Core Insights - Traws Pharma is advancing its antiviral pipeline with multiple regulatory submissions for tivoxavir marboxil (TXM) and ratutrelvir, targeting seasonal and bird flu as well as COVID-19 [1][2][3] Group 1: Tivoxavir Marboxil (TXM) - A Phase 2 study protocol has been submitted to evaluate TXM in patients with seasonal influenza and H5N1 bird flu, aiming for a non-inferiority comparison with XOFLUZA® [2][3] - The study will enroll subjects in Australia and Southeast Asia, regions with high rates of human bird flu infections, to assess TXM's efficacy [2][3] - Traws Pharma is in discussions with the FDA regarding accelerated approval pathways for TXM under the Animal Rule [4][3] - TXM is designed as a single-dose oral treatment with demonstrated in vitro activity against various influenza strains, including H5N1 [8] Group 2: Ratutrelvir - A separate Phase 2 study protocol has been submitted for ratutrelvir, a protease inhibitor for newly diagnosed COVID patients, comparing it to PAXLOVID [4][6] - The study will evaluate a 10-day treatment regimen for ratutrelvir against the 5-day regimen for PAXLOVID, focusing on efficacy, safety, disease rebound, and Long COVID incidence [4][5] - Ratutrelvir is positioned as a ritonavir-independent treatment, potentially broadening its use among patients ineligible for PAXLOVID [9][6] Group 3: Market Potential - The seasonal influenza antiviral market represents a multi-billion dollar opportunity, driven by global health organizations and potential pandemic outbreaks [8] - The COVID-19 treatment market also presents significant potential, with ratutrelvir aiming to address gaps in existing therapies [9]

Core Viewpoint - Traws Pharma is advancing the development of tivoxavir marboxil (TXM) as a treatment for bird flu and seasonal influenza, with recent FDA feedback guiding their regulatory strategy and clinical study plans [1][2][3]. Group 1: FDA Interaction and Development Plans - The FDA provided written responses regarding the development paths for TXM, including the potential use of the Animal Rule for approval [1][2]. - Traws Pharma is requesting a Type D meeting with the FDA to clarify next steps in the development process for TXM [2]. - The company aims to conduct a combined clinical study involving subjects infected with seasonal and bird flu [2]. Group 2: Therapeutic Efficacy and Urgency - Positive therapeutic effects of TXM have been observed in three animal models of bird flu, reinforcing the need for rapid progression towards stockpiling and pandemic readiness [3]. - Traws Pharma has initiated discussions with the Biomedical Advanced Research and Development Authority (BARDA) for stockpiling TXM in preparation for potential pandemics [3]. - The historical context of H5N1 virus outbreaks, which have had death rates up to 50%, underscores the urgency of these actions [3]. Group 3: Product Overview and Market Opportunity - TXM is an investigational oral small molecule designed as a single-dose treatment for bird flu and seasonal influenza, showing potent in vitro activity against various influenza strains [4]. - The seasonal influenza market represents a multi-billion dollar opportunity, driven by global health organizations and government tenders, with additional potential from pandemic outbreaks [4]. - The data supporting TXM's development as a treatment for both bird flu and seasonal flu is considered robust [4].

FDA briefing document submitted April 24, 2025 in support of a meeting to align on pathway for tivoxavir marboxil (TXM, bird flu/seasonal flu) including potential for accelerated approval utilizing the "Animal Rule" Additional briefing document in support of a meeting to align on ratutrelvir for COVID - including Long COVID - to be submitted to regulatory authorities in Q2 2025 Cash runway to support planned operations into Q1 2026 NEWTOWN, Pa., May 15, 2025 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ: T ...

Core Viewpoint - Traws Pharma announced positive topline results from a study of tivoxavir marboxil (TXM) as a treatment for H5N1 bird flu in non-human primates, indicating its potential as a novel therapy for respiratory viral diseases [1][3][4]. Group 1: Study Results - The study involved ten non-human primates, with TXM administered as a single dose equivalent to 480 mg for humans, showing significant reduction in lung viremia and prevention of weight loss [2][5]. - TXM-treated animals had lung viremia levels consistently below the quantitation limit of 2X10^3 infectious particles per ml, while control animals reached levels as high as 1X10^7 infectious particles per ml [5]. - Control animals lost an average of 4.2% of their body weight over ten days post-challenge, whereas TXM-treated animals maintained stable or slightly increased body weight (p<0.004) [5]. Group 2: Regulatory Path and Future Plans - The company plans to meet with the FDA in the first half of 2025 to discuss the regulatory path for TXM, including the potential for accelerated approval under the "Animal Rule" [3][4]. - An Investor Event is scheduled for March 31, 2025, to present an overview of preclinical and human data on TXM and discuss next steps towards approval [4][5]. Group 3: Broader Implications - The ongoing threat of bird flu, particularly with reports of mutations increasing pandemic risk, underscores the importance of developing effective antiviral treatments like TXM [3][6]. - TXM has shown consistent therapeutic effects across multiple animal models, including ferrets and mice, reinforcing its potential as a treatment for both bird flu and seasonal influenza [5][6][12].

Poster underscores Tivoxavir Marboxil’s potential for the treatment of bird flu, supported by 100% survival in a rodent challenge model, potent suppression of resistant viruses and Phase 1 dataFull dataset to be highlighted during Investor Call on March 31, 2025 at 10:00 AM ET NEWTOWN, Pa., March 21, 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 h ...

Core Viewpoint - Traws Pharma, Inc. has presented positive data supporting the potential of tivoxavir marboxil (TXM) as a treatment for bird flu at the International Society for Antiviral Research (ICAR 2025) conference, indicating its effectiveness and safety profile [1][2]. Company Overview - Traws Pharma is a clinical-stage biopharmaceutical company focused on developing novel therapies for respiratory viral diseases, including bird flu and seasonal influenza [8][9]. - The company aims to create investigational antiviral agents that are potent against difficult-to-treat or resistant virus strains, with a commitment to patient safety and simple dosing regimens [8]. Product Development - Tivoxavir marboxil (TXM) is an investigational oral small molecule designed as a single-dose treatment targeting the influenza cap-dependent endonuclease (CEN) [9]. - The data presented at ICAR highlighted that TXM demonstrated 100% survival in a rodent challenge model against H5N1 bird flu, with significant reductions in lung viremia and no virus-induced weight loss [6][5]. - Laboratory studies showed TXM's potent suppression of influenza A, B, and C viruses, including those resistant to baloxavir, with sub-nanomolar potency against H5N1 [6]. Clinical Trials and Regulatory Plans - Phase 1 trial results indicated that a single dose of TXM maintained plasma blood levels at EC90 for approximately three weeks, demonstrating good overall tolerability [6]. - The company plans to meet with the FDA to discuss next steps, including the potential for an accelerated path to approval for TXM [2]. Market Opportunity - Seasonal influenza represents a significant multi-billion dollar antiviral market opportunity, driven by global health organizations and government tenders, with additional potential from pandemic flu outbreaks like H5N1 [7].