logo
#

Latest news with #GLP-1R

BrightGene Presents Positive Phase 2 Data for Dual GLP-1R/GIPR Agonist for Weight Management and Type 2 Diabetes and Preclinical Data for Novel Amylin Analog at American Diabetes Association's 85th Scientific Sessions
BrightGene Presents Positive Phase 2 Data for Dual GLP-1R/GIPR Agonist for Weight Management and Type 2 Diabetes and Preclinical Data for Novel Amylin Analog at American Diabetes Association's 85th Scientific Sessions

Yahoo

time24-06-2025

  • Business
  • Yahoo

BrightGene Presents Positive Phase 2 Data for Dual GLP-1R/GIPR Agonist for Weight Management and Type 2 Diabetes and Preclinical Data for Novel Amylin Analog at American Diabetes Association's 85th Scientific Sessions

Phase 2 data highlights best-in-class potential of dual GLP-1R/GIPR agonist BGM0504 for weight management and metabolic risk reduction in individuals with type 2 diabetes and overweight, non-obese individuals Preclinical data for BGM1812 supports further development as next-generation amylin analog for obesity treatment SUZHOU, China, June 23, 2025 /CNW/ -- BrightGene Pharmaceutical Co., Ltd., an international, innovation-driven pharmaceutical company, presented data from two Phase 2 studies for BGM0504, its investigational dual agonist targeting glucagon-like peptide-1 receptor (GLP-1R) and glucose-dependent insulinotropic polypeptide receptor (GIPR), along with preclinical data for its novel amylin analog, BGM1812, at the 85th Scientific Conference of the American Diabetes Association (ADA). Results from two separate Phase 2 studies in BGM0504 demonstrated significant potential for weight management and metabolic risk reduction in individuals with type 2 diabetes (including superiority to semaglutide), and in overweight and obese non-diabetic individuals, respectively. Preclinical data for BGM1812 demonstrated superior receptor activation, robust weight loss and synergistic potential with GLP-1/GIP dual agonism, supporting its development as a next-generation amylin analog for obesity treatment. "These Phase 2 data highlight the significant, best-in-class potential of BGM0504 as a treatment for type 2 diabetes and obesity, including potential superiority to semaglutide and a strong safety profile, while our preclinical data for BGM1812 support its continued development as a next-generation amylin analog for obesity treatment, underscoring the additional promise in our pipeline," said Dr. Jiandong Yuan, CEO, BrightGene. "Building on our extensive peptide expertise and strong heritage in high-quality, efficient drug development, BrightGene is committed to accelerating innovative therapeutics to help address unmet patient needs in metabolic disease and other important therapeutic areas." BGM0504 Phase 2 Study in Type 2 Diabetes This multicenter, randomized, double-blind (placebo-controlled) and open-label (semaglutide positive-controlled) evaluated the pharmacokinetics, safety and efficacy of once-weekly subcutaneous injection of BGM0504 across the primary endpoint, change from baseline in HbA1c at Week 12 of target dose administration, and multiple secondary endpoints including PPG-2h, FPG, body weight, HbA1c and combined HbA1c/body weight targets proportions, HOMA2-B, blood lipids, systolic blood pressure (SBP) and diastolic blood pressure (DBP). The study enrolled 67 participants with type 2 diabetes between the ages of 18 and 65, 64 received dose after randomization, randomized into five groups: 5mg (n=13), 10mg (n=12), 15mg (n=13), positive-control group (semaglutide; n=16) or placebo (n=13). Enrolled participants included adults with a baseline HbA1c between 7.0% and 10.0%, and a body mass index (BMI) between 19.5 and 35 kg/m2. At Week 12 of target dose administration, treatment with BGM0504 resulted in reductions in HbA1c across the three dose groups that were statistically significant compared with the placebo group and greater than treatment with semaglutide, including -1.72% in the 5mg dose group, -1.94% in the 10mg dose group, and -2.48% in 15mg dose group, compared to -1.43% in semaglutide and -0.28% in placebo. Similar results were observed in multiple secondary endpoints, including PPG-2h, FPG, body weight, and HbA1c and combined HbA1c/body weight target proportions, while varying improvement trends were observed in HOMA2-B, blood lipids, SBP and DBP. Most treatment emergent adverse events (TEAEs) were Grade 1 or 2 during the rapid titration stage and gradually tolerated after reaching the target dose. The most common treatment-related gastrointestinal AEs were diarrhea, nausea and abdominal distension; no hypoglycemic or other unexpected adverse reactions occurred. BGM0504 Phase 2 Study in Obesity This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of BGM0504 in 120 Chinese adults with obesity during multiple-dose administration (subcutaneous injection). Enrolled participants included adults with a BMI ≥ 24kg/m2 (mean BMI at enrollment ≥ 27kg/m2) with prediabetes and/or at least one obesity-related comorbidity, or adults with obesity (BMI≥ 28kg/m2, mean BMI at enrollment ≥ 30kg/m2). Participants were randomized into four groups: 5 mg (n=30), 10 mg (n=30), 15 mg(n=30), or placebo (n=30). The study consisted of a titration phase (2-6 weeks), 24-week treatment with once-weekly dosing, and a 2-week follow-up. Study results demonstrated reductions in waist circumference ranging from −8.0 cm to −12.98 cm (p < 0.001), and significant weight reductions ranging from -10.77% to 19.78% (LS means, placebo adjusted). Results also showed improvements in systolic blood pressure ranging from −11.60 to −13.03 mmHg and diastolic blood pressure ranging from −5.98 to −7.50 mmHg (p < 0.05). Secondary outcomes further supported the efficacy of BGM0504, and all doses were well tolerated with common adverse events. BGM1812 Preclinical Study In a preclinical study, BGM1812 demonstrated strong receptor activation with 1.8× and 2.2× increased agonist activity (EC50) at the amylin and calcitonin receptors, respectively, versus petrelintide. The agonist also demonstrated dose-dependent weight loss in 0.012 - 0.12 mg/kg dose range in the diet-induced obese (DIO) rat model. At 0.04 mg/kg, BGM1812 achieved greater weight reduction than petrelintide. In addition, BGM1812 significantly preserved relative lean mass while reducing relative fat mass. Additionally, the combination of BGM1812 and BGM0504 resulted in greater and more sustained weight loss than either semaglutide+cagrilintide or amycretin in the DIO rat model. About BGM0504 The peptide hypoglycemic drug BGM0504 injection is a dual agonist of GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulinotropic polypeptide) receptors independently developed by BrightGene. BGM0504 can stimulate the downstream pathways of GIP and GLP-1, produce biological effects such as controlling blood sugar, reducing weight and treating non-alcoholic steatohepatitis (NASH), and show potential for the treatment of various metabolic diseases. BGM0504 is currently in Phase 3 trials in China for weight management and type 2 diabetes and has completed a Phase 1 bridging study for weight management in the U.S. To date, BGM0504 has been investigated in more than 1,000 patients and demonstrated superior efficacy and a strong safety profile. About BGM1812 BGM1812 is a novel amylin analog designed using AI/ML-driven optimization to enhance agonist activities and formulation properties. A potent and ultra long-acting amylin, BGM1812 has the potential to be a once weekly oral tablet. About BrightGene BrightGene is an international, innovation-driven pharmaceutical company, listed on the Shanghai Stock Exchange, dedicated to developing and manufacturing high-quality therapeutics to address unmet patient needs. Founded in 2001, BrightGene has evolved from an established global leader in high-hurdle generics and biosimilars to developing innovative metabolic and respiratory therapeutics. An established leader in challenging chemistry and conjugation, BrightGene has proprietary, cutting-edge platforms in peptides, siRNA, nanobodies, as well as advanced formulations, and 272 patents. The company remains a global supplier of 15 APIs and 2 drug products to the US and EU. BrightGene is headquartered in China. Additional information is available at View original content: SOURCE Bright Gene 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

BrightGene Presents Positive Phase 2 Data for Dual GLP-1R/GIPR Agonist for Weight Management and Type 2 Diabetes and Preclinical Data for Novel Amylin Analog at American Diabetes Association's 85th Scientific Sessions
BrightGene Presents Positive Phase 2 Data for Dual GLP-1R/GIPR Agonist for Weight Management and Type 2 Diabetes and Preclinical Data for Novel Amylin Analog at American Diabetes Association's 85th Scientific Sessions

Cision Canada

time24-06-2025

  • Business
  • Cision Canada

BrightGene Presents Positive Phase 2 Data for Dual GLP-1R/GIPR Agonist for Weight Management and Type 2 Diabetes and Preclinical Data for Novel Amylin Analog at American Diabetes Association's 85th Scientific Sessions

Phase 2 data highlights best-in-class potential of dual GLP-1R/GIPR agonist BGM0504 for weight management and metabolic risk reduction in individuals with type 2 diabetes and overweight, non-obese individuals Preclinical data for BGM1812 supports further development as next-generation amylin analog for obesity treatment SUZHOU, China, June 23, 2025 /CNW/ -- BrightGene Pharmaceutical Co., Ltd., an international, innovation-driven pharmaceutical company, presented data from two Phase 2 studies for BGM0504, its investigational dual agonist targeting glucagon-like peptide-1 receptor (GLP-1R) and glucose-dependent insulinotropic polypeptide receptor (GIPR), along with preclinical data for its novel amylin analog, BGM1812, at the 85 th Scientific Conference of the American Diabetes Association (ADA). Results from two separate Phase 2 studies in BGM0504 demonstrated significant potential for weight management and metabolic risk reduction in individuals with type 2 diabetes (including superiority to semaglutide), and in overweight and obese non-diabetic individuals, respectively. Preclinical data for BGM1812 demonstrated superior receptor activation, robust weight loss and synergistic potential with GLP-1/GIP dual agonism, supporting its development as a next-generation amylin analog for obesity treatment. "These Phase 2 data highlight the significant, best-in-class potential of BGM0504 as a treatment for type 2 diabetes and obesity, including potential superiority to semaglutide and a strong safety profile, while our preclinical data for BGM1812 support its continued development as a next-generation amylin analog for obesity treatment, underscoring the additional promise in our pipeline," said Dr. Jiandong Yuan, CEO, BrightGene. "Building on our extensive peptide expertise and strong heritage in high-quality, efficient drug development, BrightGene is committed to accelerating innovative therapeutics to help address unmet patient needs in metabolic disease and other important therapeutic areas." BGM0504 Phase 2 Study in Type 2 Diabetes This multicenter, randomized, double-blind (placebo-controlled) and open-label (semaglutide positive-controlled) evaluated the pharmacokinetics, safety and efficacy of once-weekly subcutaneous injection of BGM0504 across the primary endpoint, change from baseline in HbA1c at Week 12 of target dose administration, and multiple secondary endpoints including PPG-2h, FPG, body weight, HbA1c and combined HbA1c/body weight targets proportions, HOMA2-B, blood lipids, systolic blood pressure (SBP) and diastolic blood pressure (DBP). The study enrolled 67 participants with type 2 diabetes between the ages of 18 and 65, 64 received dose after randomization, randomized into five groups: 5mg (n=13), 10mg (n=12), 15mg (n=13), positive-control group (semaglutide; n=16) or placebo (n=13). Enrolled participants included adults with a baseline HbA1c between 7.0% and 10.0%, and a body mass index (BMI) between 19.5 and 35 kg/m 2. At Week 12 of target dose administration, treatment with BGM0504 resulted in reductions in HbA1c across the three dose groups that were statistically significant compared with the placebo group and greater than treatment with semaglutide, including -1.72% in the 5mg dose group, -1.94% in the 10mg dose group, and -2.48% in 15mg dose group, compared to -1.43% in semaglutide and -0.28% in placebo. Similar results were observed in multiple secondary endpoints, including PPG-2h, FPG, body weight, and HbA1c and combined HbA1c/body weight target proportions, while varying improvement trends were observed in HOMA2-B, blood lipids, SBP and DBP. Most treatment emergent adverse events (TEAEs) were Grade 1 or 2 during the rapid titration stage and gradually tolerated after reaching the target dose. The most common treatment-related gastrointestinal AEs were diarrhea, nausea and abdominal distension; no hypoglycemic or other unexpected adverse reactions occurred. BGM0504 Phase 2 Study in Obesity This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of BGM0504 in 120 Chinese adults with obesity during multiple-dose administration (subcutaneous injection). Enrolled participants included adults with a BMI ≥ 24kg/m 2 (mean BMI at enrollment ≥ 27kg/m 2) with prediabetes and/or at least one obesity-related comorbidity, or adults with obesity (BMI≥ 28kg/m2, mean BMI at enrollment ≥ 30kg/m2). Participants were randomized into four groups: 5 mg (n=30), 10 mg (n=30), 15 mg(n=30), or placebo (n=30). The study consisted of a titration phase (2-6 weeks), 24-week treatment with once-weekly dosing, and a 2-week follow-up. Study results demonstrated reductions in waist circumference ranging from −8.0 cm to −12.98 cm (p < 0.001), and significant weight reductions ranging from -10.77% to 19.78% (LS means, placebo adjusted). Results also showed improvements in systolic blood pressure ranging from −11.60 to −13.03 mmHg and diastolic blood pressure ranging from −5.98 to −7.50 mmHg (p < 0.05). Secondary outcomes further supported the efficacy of BGM0504, and all doses were well tolerated with common adverse events. BGM1812 Preclinical Study In a preclinical study, BGM1812 demonstrated strong receptor activation with 1.8× and 2.2× increased agonist activity (EC50) at the amylin and calcitonin receptors, respectively, versus petrelintide. The agonist also demonstrated dose-dependent weight loss in 0.012 - 0.12 mg/kg dose range in the diet-induced obese (DIO) rat model. At 0.04 mg/kg, BGM1812 achieved greater weight reduction than petrelintide. In addition, BGM1812 significantly preserved relative lean mass while reducing relative fat mass. Additionally, the combination of BGM1812 and BGM0504 resulted in greater and more sustained weight loss than either semaglutide+cagrilintide or amycretin in the DIO rat model. About BGM0504 The peptide hypoglycemic drug BGM0504 injection is a dual agonist of GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulinotropic polypeptide) receptors independently developed by BrightGene. BGM0504 can stimulate the downstream pathways of GIP and GLP-1, produce biological effects such as controlling blood sugar, reducing weight and treating non-alcoholic steatohepatitis (NASH), and show potential for the treatment of various metabolic diseases. BGM0504 is currently in Phase 3 trials in China for weight management and type 2 diabetes and has completed a Phase 1 bridging study for weight management in the U.S. To date, BGM0504 has been investigated in more than 1,000 patients and demonstrated superior efficacy and a strong safety profile. About BGM1812 BGM1812 is a novel amylin analog designed using AI/ML-driven optimization to enhance agonist activities and formulation properties. A potent and ultra long-acting amylin, BGM1812 has the potential to be a once weekly oral tablet. BrightGene is an international, innovation-driven pharmaceutical company, listed on the Shanghai Stock Exchange, dedicated to developing and manufacturing high-quality therapeutics to address unmet patient needs. Founded in 2001, BrightGene has evolved from an established global leader in high-hurdle generics and biosimilars to developing innovative metabolic and respiratory therapeutics. An established leader in challenging chemistry and conjugation, BrightGene has proprietary, cutting-edge platforms in peptides, siRNA, nanobodies, as well as advanced formulations, and 272 patents. The company remains a global supplier of 15 APIs and 2 drug products to the US and EU. BrightGene is headquartered in China. Additional information is available at .

Terns Pharmaceuticals Presents Positive Data from Phase 1 Study of TERN-601 Once-daily Oral GLP-1R Agonist for Treatment of Obesity at 85th Annual American Diabetes Association Scientific Sessions
Terns Pharmaceuticals Presents Positive Data from Phase 1 Study of TERN-601 Once-daily Oral GLP-1R Agonist for Treatment of Obesity at 85th Annual American Diabetes Association Scientific Sessions

Yahoo

time23-06-2025

  • Business
  • Yahoo

Terns Pharmaceuticals Presents Positive Data from Phase 1 Study of TERN-601 Once-daily Oral GLP-1R Agonist for Treatment of Obesity at 85th Annual American Diabetes Association Scientific Sessions

Phase 1 clinical study of TERN-601 demonstrated differentiated profile in 28-day study; topline data were presented in September 2024 Phase 2 FALCON clinical trial of TERN-601 completed enrollment; 12-week data expected in 4Q 2025 FOSTER CITY, Calif., June 23, 2025 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. ('Terns' or the 'Company') (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity, today announced that data from the completed Phase 1 study of TERN-601, a novel once-daily oral GLP-1R agonist, will be highlighted at the American Diabetes Association (ADA) 85th Scientific Sessions, taking place June 20-23, 2025, in Chicago, IL. 'We are thrilled to be selected for an oral presentation at ADA to highlight additional data from the 28-day Phase 1 study of TERN-601 demonstrating its differentiated profile among oral GLP1-R agonists,' said Amy Burroughs, chief executive officer of Terns. 'In addition, we are pleased to share the recent completion of enrollment for our Phase 2 FALCON trial where the key objectives of the trial are to demonstrate TERN-601's competitive weight loss at 12-weeks, a class leading safety and tolerability profile, and the simplest dose titration amongst GLP-1R agonist therapies.' Topline data from the Phase 1 clinical study being presented at ADA were reported in September 2024 and provided the recommended doses taken forward in the ongoing Phase 2 FALCON study, which recently completed enrollment, with topline data expected in the fourth quarter of 2025. Key highlights from the ADA presentation include: Efficacy Statistically significant and dose-dependent weight loss up to 5.5% over 28 days with QD dosing Dose related increase in weight loss with 67% of patients losing 5% or more body weight at top dose Unique pharmaceutical properties result in flat PK curve allowing 24hr target coverage with QD dosing and effective half-life of 9-10 hours Higher gut vs. plasma exposures and low free fraction drives meaningful weight loss without sacrificing tolerability Safety Well-tolerated despite rapid dose titration every three days No treatment related interruptions, reductions, discontinuations at any dose >95% of GI AEs were mild despite rapid titration No meaningful changes in liver enzymes, vital signs or ECGs Tolerability and ease of use Simplest dose titration amongst GLP1-RA therapies Dosing with or without food Can be administered with PPIs, H2RA and/or antacids The presentations and viewing detail are listed below: Presentation Title: Effect of Oral Small Molecule GLP-1 Receptor Agonist TERN-601 in Healthy Participants with Obesity or Overweight – A First-in-Human Study Abstract Number: 307-OR Presentation Date and Time: Monday, June 23, 2025; 2:30-2:45 PM CT Session Name: Early Phase, Post Hoc, and Subgroup Analyses from Clinical Trials with lncretin-Based Therapies-Take 2 Presenter: Cara H. Nelson, Terns Pharmaceuticals, Foster City, CA, USA Presentation Title: No Effect of Food or Proton Pump Inhibitor on the Pharmacokinetics of TERN-601, an Oral Small Molecule GLP-1 Receptor Agonist Abstract Number: 767-P Presentation Date and Time: Sunday Jun 22, 2025; 12:30 PM - 1 :30 PM CT Session Name: Clinical Therapeutics-lncretin-Based Therapies Presenter: Cara H. Nelson, Terns Pharmaceuticals, Foster City, CA, USA About the TERN-601 Phase 1 Trial The Phase 1 trial was a randomized, double-blind, placebo-controlled single and multiple-ascending dose (SAD and MAD) trial to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of TERN-601 in healthy adults with obesity or overweight. The trial consisted of two parts. Part 1 (SAD) was a single ascending dose study that evaluated five TERN-601 dose levels in healthy participants with a Body Mass Index (BMI) of ≥ 25 kg/m2 and < 40 kg/m2. The starting TERN-601 dose was 30 mg, with subsequent dose levels based on review of emerging safety and PK data from prior cohorts. In Part 2 (MAD) of the trial, obese and overweight healthy adults were enrolled in cohorts that included titration of TERN-601 administered for 28 days at doses selected based on data from Part 1 (SAD). Part 2 included healthy participants with a BMI of ≥ 27 kg/m2 to < 40 kg/m2. The primary endpoint of the trial was to evaluate safety and tolerability of TERN-601 administered once-daily for 28 days. Secondary endpoints included PK, efficacy as measured by body weight loss following 28 days of treatment with TERN-601, and other exploratory markers. About FALCON Phase 2 Trial FALCON is an ongoing U.S.-based, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of TERN-601, with once-daily dosing with or without food in adults with obesity or who are overweight, without diabetes (BMI ranges from ≥30 to <50 kg/m2 or ≥27 to <30 kg/m2 with at least one weight-related comorbidity). Patients are randomized to one of four active cohorts (n=30 per cohort): 250 mg, 500 mg, 500 mg slow titration, 750 mg or placebo. The primary endpoint is percent change from baseline in body weight compared to placebo over 12 weeks and secondary endpoints include safety, tolerability and proportion of patients achieving 5% weight loss or greater. About Terns Pharmaceuticals Terns Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity. Terns' pipeline contains three clinical stage development programs including an allosteric BCR-ABL inhibitor, a small-molecule GLP-1 receptor agonist, a THR-β agonist, and a preclinical GIPR modulator discovery effort, prioritizing a GIPR antagonist nomination candidate. For more information, please visit: Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements about the Company within the meaning of the federal securities laws. Forward-looking statements include statements related to or in connection with the novelty and growth of the Company's intellectual property portfolio; expectations, timing and potential results of the clinical trials and other development activities of the Company and its partners, including with respect to the FALCON trial; the potential indications to be targeted by the Company with its small-molecule product candidates; the therapeutic potential of the Company's small-molecule product candidates; the potential for the mechanisms of action of the Company's product candidates to be therapeutic targets for their targeted indications; the potential utility and progress of the Company's product candidates in their targeted indications, including the clinical utility of the data from and the endpoints used in the Company's clinical trials; the potential differentiation of the Company's small-molecule product candidates compared to similar or competitive products or product candidates; the Company's clinical development plans and activities, including the results of any interactions with regulatory authorities on its programs; the Company's expectations regarding the profile of its product candidates, including efficacy, tolerability, safety, metabolic stability and pharmacokinetic profile and potential differentiation as compared to other products or product candidates; the Company's plans for and ability to continue to execute on its current development strategy, including potential combinations involving multiple product candidates; and the Company's expectations with regard to its cash runway and sufficiency of its cash resources. All statements other than statements of historical facts contained in this press release, including statements regarding the Company's strategy, future financial condition, future operations, future trial results, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as 'believe, 'develop', 'expect', and 'objective' and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results and the implementation of the Company's plans to vary materially, including the risks associated with the initiation, cost, timing, progress, results and utility of the Company's current and future research and development activities and preclinical studies and clinical trials. These risks are not exhaustive. For a detailed discussion of the risk factors that could affect the Company's actual results, please refer to the risk factors identified in the Company's SEC reports, including but not limited to its Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent Quarterly Reports on Form 10-Q. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason. Contacts for Terns InvestorsKaytee Bock Zafereoinvestors@ MediaJenna UrbanCG Lifemedia@

Novo Nordisk signs $812m research deal with Deep Apple for non-GLP-1 drugs
Novo Nordisk signs $812m research deal with Deep Apple for non-GLP-1 drugs

Yahoo

time12-06-2025

  • Business
  • Yahoo

Novo Nordisk signs $812m research deal with Deep Apple for non-GLP-1 drugs

Novo Nordisk is eyeing a cardiometabolic drug market future that is not purely dominated by incretins, after signing a $812m partnership with Deep Apple Therapeutics to access novel compounds for obesity and other diseases. The research collaboration and exclusive worldwide license agreement will see Deep Apple tasked with discovering and optimising drug candidates directed at a non-incretin G protein-coupled receptor target. Novo Nordisk will then have the option to develop, manufacture, and commercialise the resulting compounds and products in all indications. Duties will be transferred before the start of clinical trials, though both companies will collaborate on the research plan. The breakdown of the $812m figure was not disclosed, though it is constituted of an upfront payment, research costs, and milestone payments. Deep Apple is also in line to receive royalties on sales on any products borne from the partnership that reach market. The agreement marks a significant moment for Novo Nordisk, as it channels substantial resources into research that is not centred around incretins. The drugmaker's flagship drug semaglutide, known under the brand names Wegovy and Ozempic for obesity and type 2 diabetes treatment respectively, targets the glucagon-like peptide-1 receptor (GLP-1R), a key component of the incretin system. Eli Lilly's rival drug tirzepatide, known under the brand names Mounjaro and Zepbound for weight loss and type 2 diabetes respectively, is a dual incretin – targeting both GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) receptors. Novo Nordisk and Deep Apple have not disclosed the name of their intended target, saying only that is a 'non-incretin G-protein coupled receptor (GPCR) that is well-suited for Deep Apple's platform.' Deep Apple's drug discovery platform combines machine-learning-powered virtual screening with structural biology enabled by cryo-electron microscopy (cryo-EM). 'Novo Nordisk is developing a range of potential oral medicines for cardiometabolic diseases across modalities and targets, as we know that people living with these diseases have different needs and preferences,' said Jacob Sten Petersen, senior vice president of diabetes, obesity and MASH therapeutic area at Novo Nordisk. 'We look forward to exploring this novel target further based on Deep Apple's AI-powered platform and expertise in small molecule drug discovery,' Petersen added. Apple Tree Partners founded the Deep Apple in 2022, investing $52m in series A funding. The biotech used these funds to establish a pipeline that includes three metabolic disease programmes, with further assets across immune disorders and endocrine diseases. Deep Apple is the latest biotech Novo Nordisk has tapped in efforts to regain market share in the cardiometabolic disease market. Eli Lilly's tirzepatide is outpacing semaglutide in terms of sales, leading to declining share prices for the Danish big pharma. Novo Nordisk's new candidate, CagriSema, was hyped as a successor to semaglutide only to produce underwhelming results in a Phase III trial. Incidentally, the company listed two new trials on this week as it continues to evaluate the efficacy of the drug. Struggles at the drugmaker culminated in long-time CEO Lars Fruergaard Jørgensen stepping down in May 2025. Other deals initiated by Novo Nordisk in 2025 include a $345m pact with Gensaic, $50m invested in Variant Bio, and a potential $2bn deal with United Laboratories for a GLP-1/GIP/glucagon triple receptor agonist. "Novo Nordisk signs $812m research deal with Deep Apple for non-GLP-1 drugs" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio

Vantive to invest $1bn for kidney care advancement
Vantive to invest $1bn for kidney care advancement

Yahoo

time02-06-2025

  • Business
  • Yahoo

Vantive to invest $1bn for kidney care advancement

Vantive is investing $1bn towards advancing its kidney care and vital organ support proposition. The company, which was formerly Baxter's kidney care unit, becoming Vantive after being spun out as part of a $3.5bn divestment deal with global investment firm Carlyle in 2024, stated that the investment would be allocated over a five-year period and have a particular focus on advancing R&D and manufacturing capacity. According to Vantive, hastening the course of innovation is critical in order to meet the demand presented by the increasing burden of chronic kidney disease (CKD) end-stage renal disease (ESRD) – which research indicates places an annual healthcare burden on Europe of around $140bn annually. In addition, there is a pressing need for acute organ support therapy options, with research indicating that 60% of patients in the intensive care unit (ICU) may have acute kidney injury. Through the development of digitally enabled dialysis and critical care products and services, the company said it aims to power earlier and better-informed clinical decision-making, minimise disruption of care for patients and clinical teams, shift kidney care management from episodic to proactive, and enhance patient-care team connectivity. In turn, Vantive also plans to build a 'stronger' foundation for digital support, with plans to develop existing products including its virtual reality (VR) training on-demand for clinicians using Vantive's therapies, and its remote patient management platform. Ahead of the European Renal Association (ERA) conference where further details are set to be announced, Vantive CEO Chris Toth said the funding underscored its commitment to 'shaping the future of kidney care and vital organ support'. 'Better outcomes are possible when care is more accessible, more intuitive, and more connected to the needs of patients as well as the realities of the modern healthcare ecosystem. 'That's why we are focused on transforming where and how therapy is delivered – from life-saving critical care for patients in a hospital, to life-sustaining dialysis for patients at home.' CKD is a metabolic disorder related to conditions such as diabetes, for Glucagon-like peptide-1 receptor agonists (GLP-1Rs) have shown promise. Due to their potentially wider therapeutic benefits, GLP-1R could potentially transform treatment paradigms of multiple chronic diseases, as per GlobalData analysis. "Vantive to invest $1bn for kidney care advancement " was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into a world of global content with local flavor? Download Daily8 app today from your preferred app store and start exploring.
app-storeplay-store