Latest news with #TrawsPharma
Associated Press
3 days ago
- Business
- Associated Press
Traws Pharma Advances Antiviral Pipeline with Multiple Regulatory Submissions
Phase 2 protocol submitted to HREC to evaluate tivoxavir marboxil (TXM) in a combined seasonal and bird flu study in the Southern Hemisphere Briefing documents submitted to FDA for a Type D meeting request to continue discussions on path forward for accelerated approval of TXM for bird flu Phase 2 study protocol submitted to HREC to evaluate ratutrelvir in newly diagnosed COVID patients, with extensions to measure disease rebound and development of Long COVID NEWTOWN, Pa., June 30, 2025 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ: TRAW) ('Traws Pharma', 'Traws' or 'the Company'), a clinical-stage biopharmaceutical company developing novel therapies to target critical threats to human health from respiratory viral diseases, today announced multiple regulatory submissions related to its antiviral pipeline. Tivoxavir marboxil A proposed Phase 2 dose-ranging, non-inferiority study will evaluate the effects of tivoxavir marboxil (TXM), a potential best in class CAP-dependent endonuclease inhibitor, compared to XOFLUZA®, in patients infected with seasonal influenza. A separate single arm will evaluate the effects of TXM in patients infected with H5N1 bird flu. The proposed study has been submitted for Human Research Ethics Committee (HREC) review and is expected to enroll subjects in Australia and selected countries in Southeast Asia (SE Asia) with high rates of human bird flu infections. 'This combined study, evaluating the effects of TXM in seasonal and bird flu patients, could support the broad use of TXM against multiple influenza strains,' commented Robert R. Redfield, MD, Chief Medical Officer for Traws Pharma and former Director of the U.S. Centers for Disease Control and Prevention (CDC). 'The high rates of animal-to-human transmission of bird flu in SE Asia should allow us to evaluate the efficacy of TXM in this important clinical setting, adding to our robust pre-clinical efficacy results of TXM against bird flu.' Also, as a follow up to recent Pre-IND FDA interactions on TXM, Traws submitted briefing materials for a Type D meeting to enable further FDA dialog on a potential path to accelerated approval for bird flu. 'We are continuing to discuss with the FDA the applicability of the Animal Rule and other routes that could support an accelerated approval of TXM for bird flu,' commented C. David Pauza, PhD, Chief Science Officer for Traws Pharma. 'We look forward to continuing positive interactions with the Agency.' Ratutrelvir A proposed Phase 2 non-inferiority study will evaluate the effects of ratutrelvir, a potential best in class protease inhibitor that does not require ritonavir co-administration, compared to PAXLOVID®, in newly diagnosed COVID patients. The proposed study that has been submitted for HREC review is intended to enroll patients on a 10-day treatment regimen for ratutrelvir compared to the approved 5-day regimen for PAXLOVID®. In addition to efficacy and safety endpoints, the proposed study will also evaluate the rates of disease rebound as well as the incidence of Long COVID. A separate single arm will evaluate the safety and efficacy of ratutrelvir in newly diagnosed COVID patients who are ineligible for treatment with PAXLOVID®. 'A significant population of patients who are at risk for poor outcomes from COVID are ineligible for PAXLOVID®. In addition, rebound infections and prevention of the development of Long COVID are unaddressed by existing therapies. We believe ratutrelvir has the potential to overcome these issues,' commented Dr. Redfield. 'Our proposed Phase 2 study is expected to highlight the differentiating attributes of ratutrelvir compared to existing approved therapies.' 'Today's announcements demonstrate our commitment to rapidly advance our antiviral portfolio,' commented Iain D. Dukes, MA, DPhil, Interim Chief Executive Officer for Traws Pharma. 'We look forward to delivering these potentially vital medicines to patients.' About Tivoxavir Marboxil Tivoxavir marboxil (TXM) is an investigational oral, small molecule CAP-dependent endonuclease inhibitor designed to be administered as a single-dose for the treatment of bird flu and seasonal influenza. It has potent in vitro activity against a range of influenza strains in preclinical studies, including a human isolate of the highly pathogenic avian flu H5N1 (bird flu). Consistent, positive preclinical data from three animal species indicate that a single dose of TXM demonstrated a therapeutic effect against H5N1 bird flu. Seasonal influenza represents an estimated multi-billion dollar antiviral market opportunity, largely driven by global health organizations, practice guidelines and government tenders1,2, with upside potential from potential pandemic flu outbreaks including H5N1 bird flu. We believe that these data support further development of TXM as a treatment for bird flu. About Ratutrelvir Ratutrelvir is an investigational oral, small molecule Mpro (3CL protease) inhibitor designed to be a broadly acting treatment for COVID-19 that is used without ritonavir. It has demonstrated in vitro activity against a range of COVID-19 strains. Preclinical and Phase 1 studies show that ratutrelvir does not require co-administration with a metabolic inhibitor, such as ritonavir, which could avoid ritonavir-associated drug-drug interactions3, and potentially enable wider patient use. Phase 1 data also show that ratutrelvir's pharmacokinetic (PK) profile demonstrated maintenance of target blood plasma levels approximately 13 times above the EC50 using the target Phase 2 dosing regimen of 600 mg/day for ten days, which may also reduce the likelihood of clinical rebound and, consequently, reduce the risk for Long COVID4. Industry data indicate that COVID treatment represents a potential multi-billion dollar market opportunity5,6. Source information: Third-party products mentioned herein are the trademarks of their respective owners. About Traws Pharma, Inc. Traws Pharma is a clinical stage biopharmaceutical company dedicated to developing novel therapies to target critical threats to human health in respiratory viral diseases. Traws integrates antiviral drug development, medical intelligence and regulatory strategy to meet real world challenges in the treatment of viral diseases. We are advancing novel investigational oral small molecule antiviral agents that have potent activity against difficult to treat or resistant virus strains that threaten human health: bird flu and seasonal influenza, and COVID-19/Long COVID. Tivoxavir marboxil is in development as a single dose treatment for bird flu and seasonal influenza, targeting the influenza cap-dependent endonuclease (CEN). Ratutrelvir is in development as a ritonavir-independent COVID treatment, targeting the Main protease (Mpro or 3CL protease). Traws is actively seeking development and commercialization partners for its legacy clinical oncology programs, rigosertib and narazaciclib. More details can be found on Traws' website at For more information, please visit and follow us on LinkedIn. Forward-Looking Statements Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties including statements regarding the Company, its business and product candidates, including the potential opportunity, benefits and the regulatory plans for tivoxavir marboxil. The Company has attempted to identify forward-looking statements by terminology including 'believes', 'estimates', 'anticipates', 'expects', 'plans', 'intends', 'may', 'could', 'might', 'will', 'should', 'preliminary', 'encouraging', 'approximately' or other words that convey uncertainty of future events or outcomes. Although Traws believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including our ability to proceed with our proposed clinical trials and to enroll sufficient subjects in such studies and trials, the success and timing of Traws' clinical trials, our ability to take advantage of expedited regulatory pathways for tivoxavir marboxil, our ability to obtain regulatory approval of tivoxavir marboxil and ratutrelvir, the expectations of our interactions with regulatory authorities, including the FDA, the Human Research Ethics Committee (HREC) and other international regulatory agencies, market conditions, regulatory requirements, changes in government regulation, the extent of the spread and threat of bird flu, seasonal influenza and COVID, and those discussed under the heading 'Risk Factors' in Traws' filings with the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements contained in this release speak only as of its date. Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except to the extent required by law. Traws Pharma Contact: Nora Brennan Traws Pharma, Inc. [email protected] Investor Contact: John Fraunces LifeSci Advisors, LLC 917-355-2395 [email protected]
Yahoo
3 days ago
- Business
- Yahoo
Traws Pharma Advances Antiviral Pipeline with Multiple Regulatory Submissions
Phase 2 protocol submitted to HREC to evaluate tivoxavir marboxil (TXM) in a combined seasonal and bird flu study in the Southern Hemisphere Briefing documents submitted to FDA for a Type D meeting request to continue discussions on path forward for accelerated approval of TXM for bird flu Phase 2 study protocol submitted to HREC to evaluate ratutrelvir in newly diagnosed COVID patients, with extensions to measure disease rebound and development of Long COVID NEWTOWN, Pa., June 30, 2025 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ: TRAW) ('Traws Pharma', 'Traws' or 'the Company'), a clinical-stage biopharmaceutical company developing novel therapies to target critical threats to human health from respiratory viral diseases, today announced multiple regulatory submissions related to its antiviral pipeline. Tivoxavir marboxil A proposed Phase 2 dose-ranging, non-inferiority study will evaluate the effects of tivoxavir marboxil (TXM), a potential best in class CAP-dependent endonuclease inhibitor, compared to XOFLUZA®, in patients infected with seasonal influenza. A separate single arm will evaluate the effects of TXM in patients infected with H5N1 bird flu. The proposed study has been submitted for Human Research Ethics Committee (HREC) review and is expected to enroll subjects in Australia and selected countries in Southeast Asia (SE Asia) with high rates of human bird flu infections. 'This combined study, evaluating the effects of TXM in seasonal and bird flu patients, could support the broad use of TXM against multiple influenza strains,' commented Robert R. Redfield, MD, Chief Medical Officer for Traws Pharma and former Director of the U.S. Centers for Disease Control and Prevention (CDC). 'The high rates of animal-to-human transmission of bird flu in SE Asia should allow us to evaluate the efficacy of TXM in this important clinical setting, adding to our robust pre-clinical efficacy results of TXM against bird flu.' Also, as a follow up to recent Pre-IND FDA interactions on TXM, Traws submitted briefing materials for a Type D meeting to enable further FDA dialog on a potential path to accelerated approval for bird flu. 'We are continuing to discuss with the FDA the applicability of the Animal Rule and other routes that could support an accelerated approval of TXM for bird flu,' commented C. David Pauza, PhD, Chief Science Officer for Traws Pharma. 'We look forward to continuing positive interactions with the Agency.' Ratutrelvir A proposed Phase 2 non-inferiority study will evaluate the effects of ratutrelvir, a potential best in class protease inhibitor that does not require ritonavir co-administration, compared to PAXLOVID®, in newly diagnosed COVID patients. The proposed study that has been submitted for HREC review is intended to enroll patients on a 10-day treatment regimen for ratutrelvir compared to the approved 5-day regimen for PAXLOVID®. In addition to efficacy and safety endpoints, the proposed study will also evaluate the rates of disease rebound as well as the incidence of Long COVID. A separate single arm will evaluate the safety and efficacy of ratutrelvir in newly diagnosed COVID patients who are ineligible for treatment with PAXLOVID®. 'A significant population of patients who are at risk for poor outcomes from COVID are ineligible for PAXLOVID®. In addition, rebound infections and prevention of the development of Long COVID are unaddressed by existing therapies. We believe ratutrelvir has the potential to overcome these issues,' commented Dr. Redfield. 'Our proposed Phase 2 study is expected to highlight the differentiating attributes of ratutrelvir compared to existing approved therapies.' 'Today's announcements demonstrate our commitment to rapidly advance our antiviral portfolio,' commented Iain D. Dukes, MA, DPhil, Interim Chief Executive Officer for Traws Pharma. 'We look forward to delivering these potentially vital medicines to patients.' About Tivoxavir Marboxil Tivoxavir marboxil (TXM) is an investigational oral, small molecule CAP-dependent endonuclease inhibitor designed to be administered as a single-dose for the treatment of bird flu and seasonal influenza. It has potent in vitro activity against a range of influenza strains in preclinical studies, including a human isolate of the highly pathogenic avian flu H5N1 (bird flu). Consistent, positive preclinical data from three animal species indicate that a single dose of TXM demonstrated a therapeutic effect against H5N1 bird flu. Seasonal influenza represents an estimated multi-billion dollar antiviral market opportunity, largely driven by global health organizations, practice guidelines and government tenders1,2, with upside potential from potential pandemic flu outbreaks including H5N1 bird flu. We believe that these data support further development of TXM as a treatment for bird flu. About Ratutrelvir Ratutrelvir is an investigational oral, small molecule Mpro (3CL protease) inhibitor designed to be a broadly acting treatment for COVID-19 that is used without ritonavir. It has demonstrated in vitro activity against a range of COVID-19 strains. Preclinical and Phase 1 studies show that ratutrelvir does not require co-administration with a metabolic inhibitor, such as ritonavir, which could avoid ritonavir-associated drug-drug interactions3, and potentially enable wider patient use. Phase 1 data also show that ratutrelvir's pharmacokinetic (PK) profile demonstrated maintenance of target blood plasma levels approximately 13 times above the EC50 using the target Phase 2 dosing regimen of 600 mg/day for ten days, which may also reduce the likelihood of clinical rebound and, consequently, reduce the risk for Long COVID4. Industry data indicate that COVID treatment represents a potential multi-billion dollar market opportunity5,6. Source information: Per link TRAW data on file Carly Herbert et al. (2025) Clinical Infectious Diseases. 10K report 2024, Feb 27, 2025 Merck & Co 10K, Feb 25, 2025 Third-party products mentioned herein are the trademarks of their respective owners. About Traws Pharma, Inc. Traws Pharma is a clinical stage biopharmaceutical company dedicated to developing novel therapies to target critical threats to human health in respiratory viral diseases. Traws integrates antiviral drug development, medical intelligence and regulatory strategy to meet real world challenges in the treatment of viral diseases. We are advancing novel investigational oral small molecule antiviral agents that have potent activity against difficult to treat or resistant virus strains that threaten human health: bird flu and seasonal influenza, and COVID-19/Long COVID. Tivoxavir marboxil is in development as a single dose treatment for bird flu and seasonal influenza, targeting the influenza cap-dependent endonuclease (CEN). Ratutrelvir is in development as a ritonavir-independent COVID treatment, targeting the Main protease (Mpro or 3CL protease). Traws is actively seeking development and commercialization partners for its legacy clinical oncology programs, rigosertib and narazaciclib. More details can be found on Traws' website at For more information, please visit and follow us on LinkedIn. Forward-Looking Statements Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties including statements regarding the Company, its business and product candidates, including the potential opportunity, benefits and the regulatory plans for tivoxavir marboxil. The Company has attempted to identify forward-looking statements by terminology including 'believes', 'estimates', 'anticipates', 'expects', 'plans', 'intends', 'may', 'could', 'might', 'will', 'should', 'preliminary', 'encouraging', 'approximately' or other words that convey uncertainty of future events or outcomes. Although Traws believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including our ability to proceed with our proposed clinical trials and to enroll sufficient subjects in such studies and trials, the success and timing of Traws' clinical trials, our ability to take advantage of expedited regulatory pathways for tivoxavir marboxil, our ability to obtain regulatory approval of tivoxavir marboxil and ratutrelvir, the expectations of our interactions with regulatory authorities, including the FDA, the Human Research Ethics Committee (HREC) and other international regulatory agencies, market conditions, regulatory requirements, changes in government regulation, the extent of the spread and threat of bird flu, seasonal influenza and COVID, and those discussed under the heading 'Risk Factors' in Traws' filings with the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements contained in this release speak only as of its date. Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except to the extent required by law. Traws Pharma Contact: Nora BrennanTraws Pharma, Investor Contact:John Fraunces LifeSci Advisors, LLC917-355-2395jfraunces@ in to access your portfolio
Yahoo
03-06-2025
- Business
- Yahoo
Traws Pharma Announces Publication of Compelling Efficacy data in RDEB SCC Patients Treated with Legacy Oncology Drug Rigosertib
NEWTOWN, Pa., June 03, 2025 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ: TRAW) ('Traws Pharma', 'Traws' or 'the Company'), a clinical-stage biopharmaceutical company developing novel therapies to target critical threats to human health from respiratory viral diseases, today announced the publication of key clinical efficacy data for rigosertib, a legacy Traws Pharma oncology asset for which development and commercialization partners are being actively sought, in patients with RDEB SCC. The paper, published in the British Journal of Dermatology1, details the first clinical trial of any experimental cancer therapeutic in this rare and complicated monogenic disease. The results indicated an overall response rate of 80%, with complete responses in 50% of evaluable patients. 'These data indicate that rigosertib is a potential treatment for cutaneous SCC in RDEB patients, where there is a substantial unmet need and no approved therapies. The aggressive course of this disease is inadequately addressed by current treatment regimens, which produce limited response rates of mostly short duration,' said Victor Moyo, MD, Chief Medical Officer Oncology, Traws Pharma. 'We are excited to report the compelling efficacy and tolerability profile of rigosertib in this devastating, difficult to treat disease, and thank the patients, sponsors and investigators for their commitment to this program,' commented Iain Dukes, MA, DPhil, Interim CEO, Traws Pharma. 'Rigosertib is available for further development and commercialization, and we are committed to finding an appropriate partner to advance this important medicine to approval.' About RDEB-associated SCC RDEB is caused by insufficient expression of type VII collagen, which is responsible for anchoring the skin's inner layer to its outer layer. This leads to extreme skin fragility as well as chronic blistering and wound formation with recurrent infections in RDEB patients, many of whom go on to develop metastatic squamous cell carcinoma driven by overexpression of polo-like kinase 1 (PLK-1). RDEB-associated SCC tumors show a highly aggressive and early metastasizing course that makes them the primary cause of death for these patients, with a cumulative risk of death of 70% and 78.7% by ages 45 and 55, respectively2,3. RDEB-associated SCC can appear in pediatric patients or in young adults. Currently available treatments such as targeted therapies and conventional chemo- and/or radiotherapy have demonstrated limited response rates and poor durability in RDEB-associated SCC2,4. Abbreviations: RDEB SCC, Recessive Dystrophic Epidermolysis Bullosa Associated Locally Advanced or Metastatic Squamous Cell Carcinoma References Martin Laimer, Andrew P South, Elisabeth Mayr, Sophie Kitzmueller, Lauren Banner, Michael Alexander, Linda Hosler, Henry Yang, Matthew Parris, Meena Arora, Georg Zimmermann, Gregor Schweighofer-Zwink, Johann W Bauer, Neda Nikbakht, Efficacy and Safety of Rigosertib in Patients with Recessive Dystrophic Epidermolysis Bullosa Associated Advanced/Metastatic Cutaneous Squamous Cell Carcinoma, British Journal of Dermatology, 2025;, ljaf205, Mellerio et al. Br J Dermatol. 2016 Jan; 174(1):56-67. doi: 10.1111/bjd.14104. Fine et al. J Am Acad Dermatol. 2009 Feb; 60(2):203-11. doi: 10.1016/ Stratigos et al. Eur J Cancer. 2020 Mar;128:83-102. doi: 10.1016/ About Rigosertib Rigosertib is a small molecule kinase inhibitor (including PLK-1). The compound is being evaluated in a series of investigator sponsored studies including as a monotherapy for potential use in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC) (NCT03786237, NCT04177498), using both oral and IV formulations. Rigosertib has also been evaluated in combination with other agents, including checkpoint inhibitors, for solid tumors including non-small cell lung cancer, and metastatic melanoma. About Traws Pharma, Inc. Traws Pharma is a clinical stage biopharmaceutical company dedicated to developing novel therapies to target critical threats to human health in respiratory viral diseases. Traws integrates antiviral drug development, medical intelligence and regulatory strategy to meet real world challenges in the treatment of viral diseases. We are advancing novel investigational oral small molecule antiviral agents that have potent activity against difficult to treat or resistant virus strains that threaten human health: bird flu and seasonal influenza, and COVID-19/Long COVID. Tivoxavir marboxil is in development as a single dose treatment for bird flu and seasonal influenza, targeting the influenza cap-dependent endonuclease (CEN). Ratutrelvir is in development as a ritonavir-independent COVID treatment, targeting the Main protease (Mpro or 3CL protease). Traws is actively seeking development and commercialization partners for its legacy clinical oncology programs, rigosertib and narazaciclib. More details can be found on Traws' website at Follow our progress on our website or on LinkedIn. Forward-Looking Statements Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties including statements regarding the Company, its business and product candidates, including the potential opportunity, benefits and the regulatory plans for its rigosertib oncology program. The Company has attempted to identify forward-looking statements by terminology including 'believes', 'estimates', 'anticipates', 'expects', 'plans', 'intends', 'may', 'could', 'might', 'will', 'should', 'preliminary', 'encouraging', 'approximately' or other words that convey uncertainty of future events or outcomes. Although Traws believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including Traws' ability to identify and enter into development and/or commercialization agreements with potential partners for its legacy rigosertib oncology program, the success and timing of Traws' clinical trials, the efficacy of rigosertib as a treatment for cutaneous SCC in RDEB patients, market conditions, regulatory requirements, changes in government regulation, and those discussed under the heading 'Risk Factors' in Traws' filings with the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements contained in this release speak only as of its date. Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except to the extent required by law. Traws Pharma ContactNora BrennanTraws Pharma, Investor Contact:Bruce Mackle LifeSci Advisors, LLC646-889-1200bmackle@
Yahoo
27-05-2025
- Business
- Yahoo
Traws Pharma Announces Receipt of FDA Guidance on Tivoxavir Marboxil and Reports Plans for Pursuing Stockpiling for Pandemic Preparedness
NEWTOWN, Pa., May 27, 2025 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ: TRAW) ('Traws Pharma', 'Traws' or 'the Company'), a clinical-stage biopharmaceutical company developing novel therapies to target critical threats to human health from respiratory viral diseases, today announced receipt of written responses to questions submitted for a Type B pre-Investigational New Drug Application meeting with the U.S. Food and Drug Administration (FDA, the Agency). The FDA provided feedback on development paths for potential approval of tivoxavir marboxil (TXM) for bird flu and seasonal flu, including on the use of the Animal Rule. The Animal Rule is intended to provide a path to approval in situations when human clinical studies would be unethical or impractical. 'The FDA has provided detailed feedback on the development paths for approval, including a combined clinical study enrolling seasonal flu and bird flu-infected subjects, as such infections occur. We are requesting a Type D meeting with the FDA to specify next steps and look forward to working closely with the Agency to develop TXM for bird flu and seasonal flu,' said C. David Pauza, PhD, Chief Science Officer for Traws Pharma. 'The consistent finding of therapeutic effects of TXM in three animal models of bird flu increases our confidence that this compound should be rapidly progressed for stockpiling and pandemic readiness by government agencies,' said Robert R. Redfield, MD, Chief Medical Officer for Traws Pharma and former Director of the U.S. Centers for Disease Control and Prevention (CDC). 'To that end, we have initiated a dialog with the Biomedical Advanced Research and Development Authority (BARDA), the responsible agency for stockpiling for pandemic preparedness in the United States, and we plan to engage with respective international regulatory agencies for the same purpose. With the known history that previous H5N1 virus outbreaks in human populations are associated with death rates of up to 50%1, we believe that these actions should be pursued with great urgency.' 'This initial interaction with the FDA has helped guide the development of TXM as a broad therapeutic against pandemic and seasonal influenza,' commented Iain Dukes, MA DPhil, Interim CEO of Traws Pharma. 'We are committed to progressing the process for stockpiling TXM to prevent any pandemic outbreaks associated with bird flu.' About Tivoxavir Marboxil Tivoxavir marboxil (TXM) is an investigational oral, small molecule CAP-dependent endonuclease inhibitor designed to be administered as a single-dose for the treatment of bird flu and seasonal influenza. It has potent in vitro activity against a range of influenza strains in preclinical studies, including a human isolate of the highly pathogenic avian flu H5N1 (bird flu). Consistent, positive preclinical data from three animal species indicate that a single dose of TXM demonstrated a therapeutic effect against H5N1 bird flu. Seasonal influenza represents an estimated multi-billion dollar antiviral market opportunity, largely driven by global health organizations, practice guidelines and government tenders2,3, with upside potential from potential pandemic flu outbreaks including H5N1 bird flu. We believe that these data support further development of tivoxavir marboxil as a treatment for bird flu and seasonal flu. Source information: Per link Per link TRAW data on file About Traws Pharma, Inc. Traws Pharma is a clinical stage biopharmaceutical company dedicated to developing novel therapies to target critical threats to human health in respiratory viral diseases. Traws integrates antiviral drug development, medical intelligence and regulatory strategy to meet real world challenges in the treatment of viral diseases. We are advancing novel investigational oral small molecule antiviral agents that have potent activity against difficult to treat or resistant virus strains that threaten human health: bird flu and seasonal influenza, and COVID-19/Long COVID. Tivoxavir marboxil is in development as a single dose treatment for bird flu and seasonal influenza, targeting the influenza cap-dependent endonuclease (CEN). Ratutrelvir is in development as a ritonavir-independent COVID treatment, targeting the Main protease (Mpro or 3CL protease). For more information, please visit and follow us on LinkedIn. Forward-Looking Statements Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties including statements regarding the Company, its business and product candidates, including the potential opportunity, benefits and the regulatory plans for tivoxavir marboxil. The Company has attempted to identify forward-looking statements by terminology including 'believes', 'estimates', 'anticipates', 'expects', 'plans', 'intends', 'may', 'could', 'might', 'will', 'should', 'preliminary', 'encouraging', 'approximately' or other words that convey uncertainty of future events or outcomes. Although Traws believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Traws' clinical trials, our ability to take advantage of expedited regulatory pathways for tivoxavir marboxil, our ability to obtain regulatory approval of tivoxavir marboxil, the expectations of our interactions with regulatory authorities, including both the FDA and BARDA and international regulatory agencies, market conditions, regulatory requirements, changes in government regulation, the extent of the spread and threat of the bird flu, and those discussed under the heading 'Risk Factors' in Traws' filings with the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements contained in this release speak only as of its date. Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except to the extent required by law. Traws Pharma Contact:Nora BrennanTraws Pharma, Investor Contact:Bruce Mackle LifeSci Advisors, LLC646-889-1200bmackle@
Yahoo
25-03-2025
- Business
- Yahoo
Traws Pharma's COVID-19 Candidate, Ratutrelvir, Presented at ICAR
Preclinical and Phase 1 data suggest that ratutrelvir can be used without ritonavir and may reduce the likelihood of COVID rebound and the risk of long COVID due to a longer treatment regimen Preparations are underway for FDA interactions and initiation of Phase 2 studies Data presentation to be provided at the Investor Event on March 31, 2025 at 10:00 AM ET NEWTOWN, Pa., March 25, 2025 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ: TRAW) ('Traws Pharma', 'Traws' or 'the Company'), a clinical-stage biopharmaceutical company developing novel therapies to target critical threats to human health from respiratory viral diseases, today announced that positive data supporting the potential for ratutrelvir, a main protease inhibitor, as a treatment for COVID-19, were presented on March 20, 2025 in a poster at the International Conference for Antiviral Research (ICAR 2025), held in Las Vegas, Nevada. Robert R. Redfield, MD, Chief Medical Officer for Traws Pharma and former Director of the U.S. Centers for Disease Control and Prevention (CDC), commented, 'Traws designed ratutrelvir to overcome the limitations of current COVID treatments. COVID continues to be a significant cause of mortality for older adults with underlying medical conditions and people who are immunocompromised1. Requirement to use the boosting agent ritonavir with widely used treatment2 increases drug-drug interaction risk for patients with complex medical conditions and may limit patient eligibility for therapy3. Data presented at ICAR provide support that ratutrelvir treatment does not require co-administration of a metabolism inhibitor such as ritonavir, significantly simplifying ease of use, a key potential differentiator.' C. David Pauza, PhD, Chief Science Officer for Traws Pharma, added: 'Recent publications cite a relationship between the probability of slow viral clearance being associated with higher risk for long COVID4. Ratutrelvir suppressed replication of 18 different strains of SARS-CoV-2 in laboratory tests, maintained human blood levels within the predicted therapeutic window (>EC90), and did not require coadministration of ritonavir. Data presented at ICAR 2025 shows that ratutrelvir is highly active against native virus and nirmatrelvir-resistant strains and omicron variants. Additionally, we know that the patterns of drug resistance mutations selected in vitro using ratutrelvir are largely distinct from the emerging clinical data on drug resistance to nirmatrelvir (protease inhibitor in Paxlovid™)4 and ensitrelvir5. Ratutrelvir is differentiated from these drugs in terms of in vitro potency, human pharmacokinetics, and drug resistance patterns.' 'We believe ratutrelvir has the potential to be a highly differentiated, broadly active treatment for COVID. Preparations are underway to meet with the FDA to align on a path forward and initiate Phase 2 studies,' noted Werner Cautreels, PhD, Chief Executive Officer for Traws Pharma. 'We plan to host an Investor Event on Monday, March 31, 2025 at 10:00 AM ET to present an overview of preclinical and human data on ratutrelvir and outline potential next steps towards approval.' To register for the virtual Investor Event, click here. Ratutrelvir poster: Poster Title: Phase I Clinical Study of Ratutrelvir, a Potent Inhibitor of the SARS-CoV-2 Main Protease (Mpro/3CL): Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Poster Date: March 20, 2025 Data in the poster suggest that ratutrelvir could be used for COVID-19 therapy without ritonavir. Phase 1 results helped Traws define a target Phase 2 dose and treatment regimen and demonstrated excellent overall safety and tolerability: Potent Preclinical Suppression of Resistant Virus: Laboratory studies show that ratutrelvir is a highly active suppressor of COVID-19 replication of original and Omicron variants Pharmacokinetic (PK) Results Do Not Require a Metabolism Inhibitor: Drug exposure studies show that ratutrelvir metabolism is not induced by ten days of treatment at 600 mg/day and trough blood plasma levels of drug are maintained at four times the EC90. These data provide support that ratutrelvir treatment does not require coadministration of a metabolism inhibitor such as ritonavir, significantly simplifying ease of use, a key differentiator Phase 1 data also show potential safety and attractive PK for a 10-day regimen: Data from single- and multiple ascending dose (SAD, MAD) studies demonstrated excellent safety/tolerability at all doses tests At the selected Phase 2 dose and regimen of 600 mg/day for 10 days, ratutrelvir established and maintained 24-hour trough blood levels of approximately 13-times the EC50 and drug levels remained above the EC90 for 2 days after treatments cessation. The 10-day dosing regimen is intended to achieve optimal viral suppression and reduce the rates for clinical rebound About RatutrelvirRatutrelvir is an investigational oral, small molecule Mpro (3CL protease) inhibitor designed to be a broadly acting treatment for COVID-19, to be used without ritonavir. It has demonstrated in vitro activity against a range of COVID-19 strains. Preclinical and Phase 1 studies show that ratutrelvir does not require co-administration with a metabolic inhibitor, such as ritonavir, which could avoid ritonavir-associated drug-drug interactions3, and potentially enable wider patient use. Phase 1 data also show that ratutrelvir's pharmacokinetic (PK) profile demonstrated maintenance of target blood plasma levels approximately 13 times above the EC50 using the target Phase 2 dosing regimen of 600 mg/day for ten days, which may also reduce the likelihood of clinical rebound and, consequently, reduce the risk for long COVID.4 Industry data indicate that COVID treatment represents a potential multi-billion dollar market opportunity7,8. Source information: Carly Herbert et al. (2025) Clinical Infectious Diseases. Tamura, T.J, et al., 2024, JAMA Network Open :e2435431-e2435431 Uehara, T., al., (2025). "Ensitrelvir treatment–emergent amino acid substitutions in SARS-CoV-2 3CLpro detected in the SCORPIO-SR phase 3 trial." Antiviral Research : 106097 10K report 2024, Feb 27, 2025 ; Merck.& Co 10K, Feb 25 2025 Paxlovid is a registered trademark of Pfizer Inc. About Traws Pharma, Pharma is a clinical stage biopharmaceutical company dedicated to developing novel therapies to target critical threats to human health in respiratory viral diseases. We are advancing novel investigational antiviral agents that have potent activity against difficult to treat or resistant virus strains that threaten human health. Our product candidates are intended to be safe, with simple dosing regimens. We strive to utilize accelerated clinical trial strategies with a commitment to patients who are especially vulnerable. The Company's two antiviral programs are investigational oral small molecules targeting bird flu and seasonal influenza, and COVID-19. Tivoxavir marboxil is in development as a single dose treatment for bird flu and seasonal influenza, targeting the influenza cap-dependent endonuclease (CEN). Ratutrelvir is in development as a COVID treatment, targeting the Main protease (Mpro or 3CL protease), without the need for co-administration of ritonavir. For more information, please visit and follow us on LinkedIn. Forward-Looking StatementsSome of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties including statements regarding the Company, its business and product candidates, including the potential opportunity, benefits, effectiveness, safety, and the clinical and regulatory plans for tivoxavir marboxil and ratutrelvir. The Company has attempted to identify forward-looking statements by terminology including 'believes', 'estimates', 'anticipates', 'expects', 'plans', 'intends', 'may', 'could', 'might', 'will', 'should', 'preliminary', 'encouraging', 'approximately' or other words that convey uncertainty of future events or outcomes. Although Traws believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Traws' clinical trials, Traws' interactions with and guidance from the FDA, collaborations, market conditions, regulatory requirements and pathways for approval, the ongoing need for improved therapy to reduce the frequency of clinical rebound and the concomitant risk for long COVID, and those discussed under the heading 'Risk Factors' in Traws' filings with the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements contained in this release speak only as of its date. Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except to the extent required by law. Traws Pharma Contact:Nora BrennanTraws Pharma, Investor Contact:Bruce Mackle LifeSci Advisors, LLC646-889-1200bmackle@ in to access your portfolio
