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Yahoo
17-06-2025
- Business
- Yahoo
Vivoryon Therapeutics N.V. Q1 2025 Financial Results and Operational Progress
Vivoryon Therapeutics N.V. Q1 2025 Financial Results and Operational Progress Continued progress in advancing varoglutamstat in kidney disease based on encouraging data and expansion of IP portfolio Varoglutamstat's pre-clinical dataset showing synergistic effect in combination with an SGLT-2 inhibitor in different treatment regimens Novel composition of matter patent for varoglutamstat granted after accelerated review in the U.S.; patent term to provide exclusivity through 2044 with subsequent opportunity for patent term extension Varoglutamstat meta-analysis data presented in oral presentation at ERA 2025 Preparations ongoing for Phase 2b of varoglutamstat in diabetic kidney disease (DKD) Management to host a conference call today at 3:00 pm CEST (9:00 am EDT) Halle (Saale) / Munich, Germany, June 17, 2025 – Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon), a clinical stage company developing small molecule medicines for inflammatory and fibrotic disorders, with a primary focus on kidney diseases, today announced financial results for the three-month period ended March 31, 2025, and provided an update on its corporate progress. 'We have started the year 2025 focused on rounding out the evidence to support the success of varoglutamstat in kidney disease,' said Frank Weber, MD, CEO of Vivoryon. 'Building on solid Phase 2 clinical evidence of varoglutamstat's beneficial impact on eGFR, we have developed a viable clinical development strategy, with a planned Phase 2b study in diabetic kidney disease as a first step. Beyond varoglutamstat as single agent, our clinical program also includes investigation of varoglutamstat in combination with SGLT-2 inhibitors for which we have generated very promising preclinical data. On the IP side, we have been able to significantly extend protection of our key asset varoglutamstat with a new composition of matter patent in the U.S. With the groundbreaking clinical data demonstrating varoglutamstat's unique impact on kidney function, a deeper understanding of its MOA in inflammation and fibrosis, and a strengthened IP portfolio, we believe we are well on track to deliver a novel therapy that addresses a significant unmet medical need for patients suffering from kidney disease. In particular, we strive to change the likely trajectory toward kidney failure for patients with advanced DKD, who currently have little to no treatment options to halt progression of kidney failure or improve kidney function.' Q1 2025 and Post-Period Updates Varoglutamstat Clinical Program Meta-analysis of VIVIAD and VIVA-MIND study data On January 14, 2025, the Company disclosed a meta-analysis of VIVIAD and VIVA-MIND data which confirmed that treatment with varoglutamstat at 600mg twice daily significantly improved eGFR kidney function in the overall study population. Statistically significant differences between varoglutamstat and placebo were first observed at week 24 and were sustained until week 96. The meta-analysis also confirmed a substantially larger effect size in study participants with diabetes compared to those without diabetes. Data for varoglutamstat were presented at the 62nd ERA Congress of the European Renal Association in Vienna, Austria, June 6, 2025, showing consistent improvement in both trials independently, replicated in the meta-analysis and pooled analysis, thus providing converging evidence for the findings. Synergistic effect of combination treatment with varoglutamstat and SGLT-2 inhibitors in pre-clinical animal model On April 29, 2025, Vivoryon disclosed preclinical data from a series of experiments in a chronic kidney disease animal model, analyzing different treatment regimens of varoglutamstat in combination with standard of care for kidney disease, the SGLT-2 inhibitor dapagliflozin. Data analysis revealed a synergistic in vivo effect for the combination treatment of dapagliflozin and varoglutamstat over a broad panel of markers, nearly normalizing pathology vs. control across the three key areas of inflammation, fibrosis and kidney function. Substantially de-risking the Company's DKD/CKD clinical development program, the strong synergistic effects observed on multiple outcome parameters suggest that QPCT/L inhibitors could be an ideal combination partner for patients treated with SGLT-2 inhibitors. Vivoryon is currently investigating additional animal models, including a DKD model, to provide further proof points. Proposed clinical development plan in DKD Vivoryon's key strategic priority for 2025 is to advance varoglutamstat in kidney disease and confirm the previously reported compelling data from two independent Phase 2 studies, VIVIAD and VIVA-MIND, by conducting a Phase 2b clinical study in patients with advanced diabetic kidney disease (DKD) stage 3b/4. Initiation of the Phase 2b and all future studies is subject to additional funding and/or partnership, which Vivoryon continues to actively explore. Expanding intellectual property portfolio in kidney disease treatment Vivoryon announced on May 27, 2025, that the United States Patent and Trademark Office (USPTO) has granted an additional patent covering the active polymorph of varoglutamstat. The new U.S. patent (US 12,312,335) was granted after an accelerated examination process and is expected to provide exclusivity through 2044 with subsequent opportunity for patent term extension of up to five years to 2049 under the Hatch-Waxman Act. Additional patents for medical use and dosing regimens under examination for varoglutamstat and related structures in kidney disease as monotherapy and in combination with SGLT-2 inhibitors. Pipeline Updates: Early-stage Pipeline The Company has enlarged its portfolio by nominating a novel, next generation QPCT/L inhibitor showing compelling pharmacological activity. This candidate, VY2149, is a potential fast follower in DKD or could also be explored for other inflammatory and fibrotic diseases including orphan diseases and chronic kidney disease (CKD). VY2149 is expected to enter formal, late-stage pre-clinical development within this year, subject to additional funding and/or partnership, which Vivoryon continues to actively explore. Corporate Development Updates In April 2025, Vivoryon entered into a Standby Equity Purchase Agreement (SEPA) withYorkville Advisors Global, LP, allowing for the purchase of up to EUR 15 million in ordinary shares over the next 36 months. Under the terms of this agreement, Yorkville has committed to acquiring these shares, providing Vivoryon with the right, but not the obligation, to sell them in individual tranches while excluding existing shareholders' pre-emptive rights. This agreement is expected to enhance Vivoryon's financial flexibility as the company seeks optimal funding solutions for its planned Phase 2b study in diabetic kidney disease. On April 29, 2025, the Company announced the appointment of Julia Neugebauer, PhD, as Chief Operating Officer (COO), effective May 1, 2025, heading investor relations and communications activities, spearheading market analysis, and overseeing various corporate functions. On May 13, 2025, Vivoryon announced that it will hold its 2025 Annual General Meeting on June 24, 2025. The full agenda and all relevant documents are available on the Company's website ( Financial Results for the First Quarter of 2025 Revenues were zero in the three months ended March 31, 2025, as well as in the three months ended March 31, 2024. Research and development expenses decreased by EUR 6.2 million to EUR 1.2 million in the three months ended March 31, 2025, compared to EUR 7.4 million in the three months ended March 31, 2024. This decrease was largely attributable to EUR 6.1 million lower third-party expenses consisting mainly of lower manufacturing cost (EUR 1.5 million) and lower clinical costs (EUR 4.5 million), predominantly due to the ramp-down of the VIVIAD and VIVA-MIND Phase 2b clinical studies. General and administrative expenses were EUR 1.3 million in the three months ended March 31, 2025, compared to EUR 2.1 million in the three months ended March 31, 2024. The decrease by EUR 0.8 million was largely attributable to lower expenses for personnel (EUR 0.3 million) as well as legal and consulting fees (EUR 0.2 million). Net loss for the three months ended March 31, 2025, was EUR 2.5 million, compared to EUR 9.3 million for the three months ended March 31, 2024. The Company held EUR 7.0 million in cash and cash equivalents as of March 31, 2025, compared to EUR 9.4 million, as of December 31, 2024. Outlook & Financial Guidance As published on April 29, 2025, the issuance date of its annual Financial Statements 2024, the Company expects, based on its most recent financial and business plan, that its existing cash and cash equivalents will be sufficient to fund its operating plans into January 2026, subject to the occurrence of unforeseen circumstances and without taking into account the SEPA as well as other potential additional financing transactions, if any. This cash runway guidance reflects an overall reduction in cash utilization including the conclusion of the VIVIAD and VIVA-MIND studies while prudently investing in preparing to execute on the Company's kidney disease strategy. The initiation of the Phase 2b DKD study is subject to further additional funding and/or partnership, which the Company continues to actively viability of the Company's business beyond its current guidance is dependent on its ability to raise additional funds to finance its operations which also depends on the success of its research and development activities such as those focusing on exploring opportunities in kidney Company expects to have continuing operating losses for the foreseeable future and the need to raise additional capital to finance its future operations. The Company has concluded that the ability to continue as a going concern in the financial year 2026, as stated in the Company's Annual Report 2024 published on April 29, 2025, depends on the ability to generate additional funding. Please refer to the Company's Annual Report 2024 for further information. Conference call and webcast Vivoryon will host a conference call and webcast today, June 17, 2025, at 3:00 pm CEST (9:00 am EDT). A Q&A session will follow the presentation of the first quarter 2025 results. A live webcast and slides will be made available at: To join the conference call via phone, participants may pre-register and will receive dedicated dial-in details to easily and quickly access the call via the following website: It is suggested participants dial into the conference call 15 minutes prior to the scheduled start time to avoid any delays in attendance. Approximately one day after the call, a slide-synchronized audio replay of the conference will be available on: ### About Vivoryon Therapeutics is a clinical stage biotechnology company focused on developing innovative small molecule-based medicines for the treatment of inflammatory and fibrotic disorders of the kidney. Driven by its passion for ground-breaking science and innovation, the Company strives to improve patient outcomes by changing the course of severe diseases through modulating the activity and stability of pathologically relevant proteins. Vivoryon's most advanced program, varoglutamstat, a proprietary, first-in-class orally available QPCT/L inhibitor, is being evaluated to treat diabetic kidney disease. press release includes forward-looking statements, including, without limitation, those regarding the business strategy, management plans and objectives for future operations of Vivoryon Therapeutics N.V. (the 'Company'), estimates and projections with respect to the market for the Company's products and forecasts and statements as to when the Company's products may be available. Words such as 'anticipate,' 'believe,' 'estimate,' 'expect,' 'forecast,' 'intend,' 'may,' 'plan,' 'project,' 'predict,' 'should' and 'will' and similar expressions as they relate to the Company are intended to identify such forward-looking statements. These forward-looking statements are not guarantees of future performance; rather they are based on the Management's current expectations and assumptions about future events and trends, the economy and other future conditions. The forward-looking statements involve a number of known and unknown risks and uncertainties. These risks and uncertainties and other factors could materially adversely affect the outcome and financial effects of the plans and events described herein. The Company's results of operations, cash needs, financial condition, liquidity, prospects, future transactions, strategies or events may differ materially from those expressed or implied in such forward-looking statements and from expectations. As a result, no undue reliance should be placed on such forward-looking statements. This press release does not contain risk factors. Certain risk factors that may affect the Company's future financial results are discussed in the published annual financial statements of the Company. This press release, including any forward-looking statements, speaks only as of the date of this press release. The Company does not assume any obligation to update any information or forward-looking statements contained herein, save for any information required to be disclosed by law. For more information, please contact: Investor ContactsVivoryon Therapeutics Manuela Bader, Director IR & CommunicationEmail: IR@ LifeSci AdvisorsSandya von der Weid Tel: +41 78 680 05 38Email: svonderweid@ Media ContactTrophic CommunicationsValeria Fisher or Verena SchossmannTel: +49 175 8041816 / +49 151 219 412 77Email: vivoryon@ Attachment 20250617_VVY Q1 2025_PRSign in to access your portfolio
Yahoo
17-06-2025
- Business
- Yahoo
Vivoryon Therapeutics N.V. Q1 2025 Financial Results and Operational Progress
Vivoryon Therapeutics N.V. Q1 2025 Financial Results and Operational Progress Continued progress in advancing varoglutamstat in kidney disease based on encouraging data and expansion of IP portfolio Varoglutamstat's pre-clinical dataset showing synergistic effect in combination with an SGLT-2 inhibitor in different treatment regimens Novel composition of matter patent for varoglutamstat granted after accelerated review in the U.S.; patent term to provide exclusivity through 2044 with subsequent opportunity for patent term extension Varoglutamstat meta-analysis data presented in oral presentation at ERA 2025 Preparations ongoing for Phase 2b of varoglutamstat in diabetic kidney disease (DKD) Management to host a conference call today at 3:00 pm CEST (9:00 am EDT) Halle (Saale) / Munich, Germany, June 17, 2025 – Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon), a clinical stage company developing small molecule medicines for inflammatory and fibrotic disorders, with a primary focus on kidney diseases, today announced financial results for the three-month period ended March 31, 2025, and provided an update on its corporate progress. 'We have started the year 2025 focused on rounding out the evidence to support the success of varoglutamstat in kidney disease,' said Frank Weber, MD, CEO of Vivoryon. 'Building on solid Phase 2 clinical evidence of varoglutamstat's beneficial impact on eGFR, we have developed a viable clinical development strategy, with a planned Phase 2b study in diabetic kidney disease as a first step. Beyond varoglutamstat as single agent, our clinical program also includes investigation of varoglutamstat in combination with SGLT-2 inhibitors for which we have generated very promising preclinical data. On the IP side, we have been able to significantly extend protection of our key asset varoglutamstat with a new composition of matter patent in the U.S. With the groundbreaking clinical data demonstrating varoglutamstat's unique impact on kidney function, a deeper understanding of its MOA in inflammation and fibrosis, and a strengthened IP portfolio, we believe we are well on track to deliver a novel therapy that addresses a significant unmet medical need for patients suffering from kidney disease. In particular, we strive to change the likely trajectory toward kidney failure for patients with advanced DKD, who currently have little to no treatment options to halt progression of kidney failure or improve kidney function.' Q1 2025 and Post-Period Updates Varoglutamstat Clinical Program Meta-analysis of VIVIAD and VIVA-MIND study data On January 14, 2025, the Company disclosed a meta-analysis of VIVIAD and VIVA-MIND data which confirmed that treatment with varoglutamstat at 600mg twice daily significantly improved eGFR kidney function in the overall study population. Statistically significant differences between varoglutamstat and placebo were first observed at week 24 and were sustained until week 96. The meta-analysis also confirmed a substantially larger effect size in study participants with diabetes compared to those without diabetes. Data for varoglutamstat were presented at the 62nd ERA Congress of the European Renal Association in Vienna, Austria, June 6, 2025, showing consistent improvement in both trials independently, replicated in the meta-analysis and pooled analysis, thus providing converging evidence for the findings. Synergistic effect of combination treatment with varoglutamstat and SGLT-2 inhibitors in pre-clinical animal model On April 29, 2025, Vivoryon disclosed preclinical data from a series of experiments in a chronic kidney disease animal model, analyzing different treatment regimens of varoglutamstat in combination with standard of care for kidney disease, the SGLT-2 inhibitor dapagliflozin. Data analysis revealed a synergistic in vivo effect for the combination treatment of dapagliflozin and varoglutamstat over a broad panel of markers, nearly normalizing pathology vs. control across the three key areas of inflammation, fibrosis and kidney function. Substantially de-risking the Company's DKD/CKD clinical development program, the strong synergistic effects observed on multiple outcome parameters suggest that QPCT/L inhibitors could be an ideal combination partner for patients treated with SGLT-2 inhibitors. Vivoryon is currently investigating additional animal models, including a DKD model, to provide further proof points. Proposed clinical development plan in DKD Vivoryon's key strategic priority for 2025 is to advance varoglutamstat in kidney disease and confirm the previously reported compelling data from two independent Phase 2 studies, VIVIAD and VIVA-MIND, by conducting a Phase 2b clinical study in patients with advanced diabetic kidney disease (DKD) stage 3b/4. Initiation of the Phase 2b and all future studies is subject to additional funding and/or partnership, which Vivoryon continues to actively explore. Expanding intellectual property portfolio in kidney disease treatment Vivoryon announced on May 27, 2025, that the United States Patent and Trademark Office (USPTO) has granted an additional patent covering the active polymorph of varoglutamstat. The new U.S. patent (US 12,312,335) was granted after an accelerated examination process and is expected to provide exclusivity through 2044 with subsequent opportunity for patent term extension of up to five years to 2049 under the Hatch-Waxman Act. Additional patents for medical use and dosing regimens under examination for varoglutamstat and related structures in kidney disease as monotherapy and in combination with SGLT-2 inhibitors. Pipeline Updates: Early-stage Pipeline The Company has enlarged its portfolio by nominating a novel, next generation QPCT/L inhibitor showing compelling pharmacological activity. This candidate, VY2149, is a potential fast follower in DKD or could also be explored for other inflammatory and fibrotic diseases including orphan diseases and chronic kidney disease (CKD). VY2149 is expected to enter formal, late-stage pre-clinical development within this year, subject to additional funding and/or partnership, which Vivoryon continues to actively explore. Corporate Development Updates In April 2025, Vivoryon entered into a Standby Equity Purchase Agreement (SEPA) withYorkville Advisors Global, LP, allowing for the purchase of up to EUR 15 million in ordinary shares over the next 36 months. Under the terms of this agreement, Yorkville has committed to acquiring these shares, providing Vivoryon with the right, but not the obligation, to sell them in individual tranches while excluding existing shareholders' pre-emptive rights. This agreement is expected to enhance Vivoryon's financial flexibility as the company seeks optimal funding solutions for its planned Phase 2b study in diabetic kidney disease. On April 29, 2025, the Company announced the appointment of Julia Neugebauer, PhD, as Chief Operating Officer (COO), effective May 1, 2025, heading investor relations and communications activities, spearheading market analysis, and overseeing various corporate functions. On May 13, 2025, Vivoryon announced that it will hold its 2025 Annual General Meeting on June 24, 2025. The full agenda and all relevant documents are available on the Company's website ( Financial Results for the First Quarter of 2025 Revenues were zero in the three months ended March 31, 2025, as well as in the three months ended March 31, 2024. Research and development expenses decreased by EUR 6.2 million to EUR 1.2 million in the three months ended March 31, 2025, compared to EUR 7.4 million in the three months ended March 31, 2024. This decrease was largely attributable to EUR 6.1 million lower third-party expenses consisting mainly of lower manufacturing cost (EUR 1.5 million) and lower clinical costs (EUR 4.5 million), predominantly due to the ramp-down of the VIVIAD and VIVA-MIND Phase 2b clinical studies. General and administrative expenses were EUR 1.3 million in the three months ended March 31, 2025, compared to EUR 2.1 million in the three months ended March 31, 2024. The decrease by EUR 0.8 million was largely attributable to lower expenses for personnel (EUR 0.3 million) as well as legal and consulting fees (EUR 0.2 million). Net loss for the three months ended March 31, 2025, was EUR 2.5 million, compared to EUR 9.3 million for the three months ended March 31, 2024. The Company held EUR 7.0 million in cash and cash equivalents as of March 31, 2025, compared to EUR 9.4 million, as of December 31, 2024. Outlook & Financial Guidance As published on April 29, 2025, the issuance date of its annual Financial Statements 2024, the Company expects, based on its most recent financial and business plan, that its existing cash and cash equivalents will be sufficient to fund its operating plans into January 2026, subject to the occurrence of unforeseen circumstances and without taking into account the SEPA as well as other potential additional financing transactions, if any. This cash runway guidance reflects an overall reduction in cash utilization including the conclusion of the VIVIAD and VIVA-MIND studies while prudently investing in preparing to execute on the Company's kidney disease strategy. The initiation of the Phase 2b DKD study is subject to further additional funding and/or partnership, which the Company continues to actively viability of the Company's business beyond its current guidance is dependent on its ability to raise additional funds to finance its operations which also depends on the success of its research and development activities such as those focusing on exploring opportunities in kidney Company expects to have continuing operating losses for the foreseeable future and the need to raise additional capital to finance its future operations. The Company has concluded that the ability to continue as a going concern in the financial year 2026, as stated in the Company's Annual Report 2024 published on April 29, 2025, depends on the ability to generate additional funding. Please refer to the Company's Annual Report 2024 for further information. Conference call and webcast Vivoryon will host a conference call and webcast today, June 17, 2025, at 3:00 pm CEST (9:00 am EDT). A Q&A session will follow the presentation of the first quarter 2025 results. A live webcast and slides will be made available at: To join the conference call via phone, participants may pre-register and will receive dedicated dial-in details to easily and quickly access the call via the following website: It is suggested participants dial into the conference call 15 minutes prior to the scheduled start time to avoid any delays in attendance. Approximately one day after the call, a slide-synchronized audio replay of the conference will be available on: ### About Vivoryon Therapeutics is a clinical stage biotechnology company focused on developing innovative small molecule-based medicines for the treatment of inflammatory and fibrotic disorders of the kidney. Driven by its passion for ground-breaking science and innovation, the Company strives to improve patient outcomes by changing the course of severe diseases through modulating the activity and stability of pathologically relevant proteins. Vivoryon's most advanced program, varoglutamstat, a proprietary, first-in-class orally available QPCT/L inhibitor, is being evaluated to treat diabetic kidney disease. press release includes forward-looking statements, including, without limitation, those regarding the business strategy, management plans and objectives for future operations of Vivoryon Therapeutics N.V. (the 'Company'), estimates and projections with respect to the market for the Company's products and forecasts and statements as to when the Company's products may be available. Words such as 'anticipate,' 'believe,' 'estimate,' 'expect,' 'forecast,' 'intend,' 'may,' 'plan,' 'project,' 'predict,' 'should' and 'will' and similar expressions as they relate to the Company are intended to identify such forward-looking statements. These forward-looking statements are not guarantees of future performance; rather they are based on the Management's current expectations and assumptions about future events and trends, the economy and other future conditions. The forward-looking statements involve a number of known and unknown risks and uncertainties. These risks and uncertainties and other factors could materially adversely affect the outcome and financial effects of the plans and events described herein. The Company's results of operations, cash needs, financial condition, liquidity, prospects, future transactions, strategies or events may differ materially from those expressed or implied in such forward-looking statements and from expectations. As a result, no undue reliance should be placed on such forward-looking statements. This press release does not contain risk factors. Certain risk factors that may affect the Company's future financial results are discussed in the published annual financial statements of the Company. This press release, including any forward-looking statements, speaks only as of the date of this press release. The Company does not assume any obligation to update any information or forward-looking statements contained herein, save for any information required to be disclosed by law. For more information, please contact: Investor ContactsVivoryon Therapeutics Manuela Bader, Director IR & CommunicationEmail: IR@ LifeSci AdvisorsSandya von der Weid Tel: +41 78 680 05 38Email: svonderweid@ Media ContactTrophic CommunicationsValeria Fisher or Verena SchossmannTel: +49 175 8041816 / +49 151 219 412 77Email: vivoryon@ Attachment 20250617_VVY Q1 2025_PR
Medscape
08-06-2025
- Health
- Medscape
Pegcetacoplan Maintains Kidney Benefits at 52 Weeks
Pegcetacoplan, a targeted C3/C3b inhibitor, shows sustained, robust effects on key markers of kidney disease in patients with C3 glomerulopathy and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), according to 52-week results from the VALIANT trial. The 26-week results, which were presented last October at Kidney Week 2024, showed a highly significant difference in change in proteinuria from baseline, as measured by the urine protein-to-creatinine ratio (uPCR); the reduction was 67.2% with pegcetacoplan vs 2.9% with placebo ( P < .0001). The current findings showed that not only were these benefits sustained in patients who remained on pegcetacoplan, patients who switched from placebo to pegcetacoplan also experienced reductions of similar magnitude, said Fadi Fakhouri, MD, of Lausanne University Hospital and the University of Lausanne, Switzerland. Fakhouri presented the 1-year results at the 62nd European Renal Association (ERA) Congress 2025. VALIANT Open-Label Period The phase 3 VALIANT trial involved 124 patients with native or post-transplant recurrent C3 glomerulopathy or primary IC-MPGN who were randomly assigned to treatment two times a week with either subcutaneous pegcetacoplan 1080 mg, or weight-based doses for adolescents weighing ≤50 kg (n = 63); or to placebo (n = 61). In the subsequent 26-week open-label period, the placebo group crossed over and all patients received pegcetacoplan. Overall, 59 (93.7%) people in the pegcetacoplan group and 55 (90.2%) in the placebo group completed the study treatment and 52-week assessment. At week 52, patients in the original pegcetacoplan group maintained the significant proteinuria reduction that was observed at week 26, with a mean urine protein-to-creatinine ratio (UPCR) change at week 26 of –67.2% and at week 52 of –68.3%. Patients in the placebo group, who experienced a +3.2% change in uPCR at week 26, experienced a reduction of –51.3% at week 52 after being switched to pegcetacoplan. In addition, eGFR levels in the pegcetacoplan group dropped slightly from -1.2 mL/min/1.73 m2 at week 26 to -3.7 mL/min/1.73 m2 at week 52; in the placebo-to-pegcetacoplan group, the corresponding changes were -7.9 mL/min/1.73 m2 at week 26 and -4.7 mL/min/1.73 m2 at week 52. In terms of safety, pegcetacoplan remained well-tolerated in the second 26 weeks, and treatment-emergent adverse events (TEAEs) were similar between the two arms during the open-label period (pegcetacoplan-to-pegcetacoplan, 77%; placebo-to-pegcetacoplan, 73.7%). Overall, infusion-related TEAEs decreased from the randomized to open-label period in the pegcetacoplan-to-pegcetacoplan group (33.3% vs 9.8%, respectively), suggesting an improvement in tolerability over time. Adherence was high, at 97.6% of patients having an adherence of ≥90% to ≤100%, overall. Infections included two cases of pneumococcal pneumonia (including one that was serious) occurring during the open-label period, and there was one case each of streptococcal pharyngitis and urinary tract infection caused by Escherichia . No patient deaths or allograft losses were reported. 'The open-label period results confirm pegcetacoplan's significant effect on kidney function,' Fakhouri said. 'Patients in the placebo arm experienced a decline in eGFR during the randomized controlled period, but a stabilization after switching to pegcetacoplan, comparable to randomized controlled period results in the pegcetacoplan group,' he added. Patients With Baseline Nephrotic Range Proteinuria The results of subanalyses looking at several other trial outcomes were also presented at the meeting. These included an analysis of patients with nephrotic range proteinuria at baseline, who are at a notably high risk of rapid disease progression to kidney failure. At baseline, 24 patients in the pegcetacoplan arm (38.1%) and 16 in the placebo arm (26.2%) had nephrotic range proteinuria, defined as a uPCR ratio ≥3 g/g. At the end of the initial 26-week period, among patients with nephrotic range proteinuria, those treated with pegcetacoplan had a relative reduction of proteinuria of 72.1% compared with placebo ( P < .0001). Patients Treated With Immunosuppressive Therapies A second subanalysis evaluated outcomes among 48 (76%) participants in the pegcetacoplan group and 42 (69%) in the placebo group who were receiving concomitant immunosuppressive therapy at baseline. Patients were permitted to continue the immunosuppressants provided that the doses had remained stable during the preceding 12-week period and throughout the trial. The outcomes between the two groups were similar: Immunosuppressant-treated patients who received pegcetacoplan had a relative reduction of 70% in proteinuria vs placebo ( P < .0001), and among patients who did not receive immunosuppressants, the relative reduction was 64.5% compared to placebo ( P = .0005). At week 26, 62.5% (30/48) of immunosuppressant‐treated patients receiving pegcetacoplan achieved a ≥50% reduction in proteinuria from baseline vs 4.8% (2/42) on placebo ( P < .0001). Among those not on immunosuppressants, 53.3% (8/15) of the pegcetacoplan group met the same endpoint compared with 5.3% (1/19) in the placebo arm ( P = .0087). 'Reassuringly, proteinuria was reduced in both groups, and the immunosuppressed group had a highly statistically significant reduction,' said David Kavanagh, MD, of the National Renal Complement Therapeutics Centre, Newcastle University, Newcastle upon Tyne, United Kingdom, who presented this subanalysis. Other outcomes, including stabilization of eGFR, were also similar to the overall reductions, including those patients not on immunosuppressants. Importantly, rates of TEAEs were also comparable between the immunosuppressed and non-immunosuppressed patients. 'If you can reduce your proteinuria by at least 50%, you're going to have an outcome that can reduce the risk of kidney failure,' Kavanagh concluded. The studies were sponsored by Apellis. Fakhouri reported relationships with Apellis, Sobi, Novartis, Roche, Alexion Pharmaceuticals, and AstraZeneca. Kavanagh reported relationships with Idorsia, Novartis, Chemocentryx, Alexion Pharmaceuticals, Samsung, Sobi, Gyroscope Therapeutics, Purespring, and Apellis.
Yahoo
06-06-2025
- Health
- Yahoo
Sobi Showcases Breadth of data in C3G/primary IC-MPGN at ERA 2025
STOCKHOLM, June 4, 2025 /PRNewswire/ -- Sobi® (STO: SOBI) will have a strong scientific presence at this year's ERA congress in Vienna (4-7 June) with a total of eight presentations: six oral presentations and two posters. We are proud that two of our abstracts have been recognised in the top 10 abstracts at ERA 2025, as selected by expert reviewers coordinated by the ERA Paper Selection Committee. Notably, 52-week results from the open-label-period (OLP) of the VALIANT Phase 3 study will be presented for the first time. This data will be featured in an oral presentation by Professor Fadi Fakhouri (Lausanne University Hospital and University of Lausanne) during the session "Innovative Kidney Trials", on 6 June 2025 at 15:00 CEST. The two abstracts selected in the top 10 at the conference both highlight important subgroup results from the randomised-controlled-period (RCP) of the VALIANT Phase 3 study covering the treatment effect of pegcetacoplan at 26 weeks in patients with nephrotic range proteinuria at baseline, and the effect of pegcetacoplan in adolescents at 26 weeks. Lydia Abad-Franch, MD, MBA, Head of Research, Development, and Medical Affairs (RDMA), and Chief Medical Officer at Sobi says, "The large number of oral presentations, including one achieving the highest ranking of all ERA abstracts and a second in the top 10, reflects the importance of the data and research outputs being generated from our work aimed at advancing treatments for rare kidney conditions." Key data to be presented at ERA 2025 VALIANT A thematic analysis of healthcare provider perspective on the care pathway and unmet needs in patients with C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in the US and Europe. Presenter: Carly Rich Poster presentation Session: Glomerular & tubulo-interstitial diseases Room: XWall 1 Mozart Symphony No. 40 Date: 5 June 2025 Time: 13:12 CEST Pegcetacoplan treatment effect in patients with nephrotic range proteinuria: results from the VALIANT Phase 3 study in patients with C3G or Primary (Idiopathic) IC-MPGN Presenter: Antonio Mastrangelo Oral presentation Session: FC 14: About C3 and IgA Glomerulonephritis Room: Hall F1 Date: 6 June 2025 Time: 08:15 CEST Targeted treatment with pegcetacoplan for adolescents with C3G or Primary (Idiopathic) IC- MPGN in the VALIANT Phase 3 trial Presenter: Antonio Mastrangelo Oral presentation Session: FC 14: About C3 and IgA Glomerulonephritis Room: Hall F1 Date: 6 June 2025 Time: 08:30 CEST Pegcetacoplan demonstrates clinically significant responses in C3G and Primary (Idiopathic) IC-MPGN patients with or without concomitant immunosuppression in VALIANT Presenter: David Kavanagh Oral presentation Session: FC 14: About C3 and IgA Glomerulonephritis Room: Hall F1 Date: 6 June 2025 Time: 09:30 CEST Association between proteinuria and clinically meaningful endpoints in patients with C3G / IC- MPGN: a Delphi consensus of European experts Presenter: Fernando Caravaca-Fontán Poster Presentation Session: Chronic Kidney Disease Room: Strauss Wiener Blut Date: 6 June 2025 Time: 13:06 CEST Pegcetacoplan for C3G and primary (idiopathic) IC- MPGN: 52-week results from the phase 3 VALIANT trial show sustained efficacy Presenter: Fadi Fakhouri Oral presentation Session: Innovative Kidney Trials Room: The Square Date: 6 June 2025 Time: 15:00 CEST Targeted Treatment with Pegcetacoplan for post- Transplant Recurrent C3G or Primary (idiopathic) IC-MPGN in the VALIANT Phase 3 Trial Presenter: Michiel Oosterveld Focused Oral presentation Session: Glomerular & tubulo-interstitial diseases Room: Focused Oral Room 3 Date: 6 June 2025 Time: 15:54 CEST Pegcetacoplan Treatment appears to halt disease progression in C3G and Primary (Idiopathic) IC-MPGN patients: results from the Phase 3 VALIANT study Presenter: Daniel Gale Focused Oral presentation Session: Glomerular & tubulo-interstitial diseases Room: Focused Oral Room 3 Date: 6 June 2025 Time: 16:06 CEST About the VALIANT Study The VALIANT Phase 3 study (NCT05067127) was a randomised, placebo-controlled, double-blinded, multi-centre study evaluating pegcetacoplan efficacy and safety in 124 patients who were 12 years of age and older, with C3G or primary IC-MPGN. It is the largest single trial conducted in these populations and the only study to include adolescent and adult patients, with native and post-transplant kidneys. During the 26-week randomised-controlled-period (RCP) of VALIANT, patients received twice weekly subcutaneous pegcetacoplan or placebo. The RCP was followed by a 26-week open-label period (OLP) in which all patients received pegcetacoplan. The primary endpoint of the study was the log transformed ratio of urine protein-to-creatinine ratio (UPCR) at week 26 compared to baseline. About Sobi Sobi is a global biopharma company unlocking the potential of breakthrough innovations, transforming everyday life for people living with rare diseases. Sobi has approximately 1,900 employees across Europe, North America, the Middle East, Asia and Australia. In 2024, revenue amounted to SEK 26 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at and LinkedIn, BlueSkyX Contacts For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here. This information was brought to you by Cision The following files are available for download: Sobi Showcases Breadth of data at ERA 2025 View original content: Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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06-06-2025
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Vivoryon Therapeutics N.V. Presents Meta-analysis Data of VIVIAD and VIVA-MIND studies at ERA 2025
Vivoryon Therapeutics N.V. Vivoryon Therapeutics N.V. Presents Meta-analysis Data of VIVIAD and VIVA-MIND studies at ERA 2025 Halle (Saale) / Munich, Germany, June 6, 2025 – Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon), a clinical stage company developing small molecule medicines for inflammatory and fibrotic disorders, with a primary focus on kidney diseases, today announced that meta-analysis data for its lead drug in development, varoglutamstat, was presented at the 62nd ERA Congress of the European Renal Association in Vienna, Austria, today, June 6, 2025. 'We are delighted that the results of the Phase 2 program were accepted for presentation at the ERA 2025 congress. This allowed Vivoryon to share the outstanding improvements of varoglutamstat on kidney function (eGFR) with the scientific and medical expert community in the kidney space,' said Frank Weber, MD, CEO of Vivoryon. Presentation Highlights Varoglutamstat is a first-in-class glutaminyl cyclase (QPCT/L) inhibitor with potent anti-inflammatory and anti-fibrotic effects. VIVIAD and VIVA-MIND, two independent Phase 2 studies in the EU and U.S. showed a statistically significant and clinically meaningful improvement in a prospectively defined kidney function parameter, eGFR, in an elderly patient population. This improvement was consistent in both trials independently, replicated in the meta-analysis and pooled analysis, and provides converging evidence for this finding. Statistically significant differences between varoglutamstat and placebo were first observed at week 24 and were sustained until week 96. The meta-analysis also confirmed a substantially larger effect size in study participants with diabetes compared to those without diabetes. The next step is planned to be a dedicated Phase 2b trial in patients with diabetic kidney disease (patients with diabetes and chronic kidney disease stage 3b/4). The main goal will be to investigate the efficacy on eGFR in this patient population and to obtain additional information on a potential effect on proteinuria and other kidney specific markers. Presentation Details Date: June 6, 2025 Presentation time: 8:15 am CEST as part of the focused oral session Title: Varoglutamstat improves eGFR and offers a new approach to treat diabetic kidney disease (DKD): meta-analysis from two independent Phase 2 studies Venue: Vienna, Austria Presenter: Frank Weber, MD, CEO of Vivoryon Therapeutics ### About Vivoryon Therapeutics N.V. Vivoryon is a clinical stage biotechnology company focused on developing innovative small molecule-based medicines for the treatment of inflammatory and fibrotic disorders of the kidney. Driven by its passion for ground-breaking science and innovation, the Company strives to improve patient outcomes by changing the course of severe diseases through modulating the activity and stability of pathologically relevant proteins. Vivoryon's most advanced program, varoglutamstat, a proprietary, first-in-class orally available QPCT/L inhibitor, is being evaluated to treat diabetic kidney disease.
