Event to highlight the differentiated features of Traws oral small molecule product candidates: Tivoxavir Marboxil, a single dose, CAP-dependent endonuclease inhibitor for Bird FluRatutrelvir, a main protease inhibitor, to be used without ritonavir, for COVID-19 NEWTON, Pa., March 26, 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 respi ...

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 regimenPreparations are underway for FDA interactions and initiation of Phase 2 studiesData 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 biopharma ...

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 regimenPreparations are underway for FDA interactions and initiation of Phase 2 studiesData 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 biopharmac ...

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].

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].

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 Insights - Traws Pharma announced positive topline results from studies on tivoxavir marboxil, showing its efficacy in treating H5N1 bird flu in ferrets, consistent with previous murine model results [1][2][3] - The company is conducting further studies in non-human primates, with data expected in Q1 2025, and plans to approach the FDA for accelerated approval under the "Animal Rule" [2][3] Company Overview - Traws Pharma is a clinical-stage biopharmaceutical company focused on developing oral small molecule therapies for respiratory viral diseases, including bird flu and seasonal influenza [6] - The company is developing two drug candidates: tivoxavir marboxil for bird flu and seasonal influenza, and ratutrelvir for COVID-19 treatment [6] Product Details - Tivoxavir marboxil is designed to inhibit the influenza protein CAP-dependent endonuclease (CEN) and has shown potent in vitro activity against various influenza strains, including H5N1 [5] - The antiviral market for bird flu and seasonal influenza is estimated to represent a multi-billion dollar opportunity, driven by global health organizations and government tenders [5]

Core Insights - Traws Pharma has regained compliance with Nasdaq's minimum stockholders' equity requirement of $2.5 million, allowing its common stock to continue trading on The NASDAQ Capital Market under the symbol "TRAW" [1][3] - The company is advancing its pipeline of investigational antivirals, particularly focusing on bird flu and influenza, with a recent successful Phase 1 trial [2][4] - Traws Pharma raised $20 million in gross proceeds through a successful offering, strengthening its financial position [3] Company Overview - Traws Pharma is a clinical-stage biopharmaceutical company developing oral small molecule therapies for respiratory viral diseases, including two novel drug candidates: tivoxavir marboxil for bird/pandemic flu and seasonal flu, and ratutrelvir for COVID-19 [4][5] - The company aims to address unmet medical needs using advanced drug development technology, focusing on product safety and solutions for vulnerable patient populations [5]

Core Viewpoint - Traws Pharma has completed Phase I clinical studies for its investigational one-dose influenza therapy, tivoxavir marboxil, aimed at treating or preventing H5N1 bird flu, with pharmacokinetic data supporting further development [1][2][3]. Group 1: Clinical Development - The Phase I trial was a randomized, double-blind, placebo-controlled study assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of ascending doses of tivoxavir marboxil in healthy adult volunteers [4]. - Topline results indicated no significant treatment-related adverse events during the study, which evaluated four dose levels [5]. - The clinical data supports accelerated development of tivoxavir marboxil in response to the increasing threat of bird flu [2][3]. Group 2: Market Opportunity - Seasonal influenza represents a multi-billion dollar antiviral market opportunity, driven by global health organizations and government tenders, with potential upside from pandemic flu outbreaks [6]. - Tivoxavir marboxil is designed to inhibit the highly conserved influenza protein, CAP-dependent endonuclease (CEN), and has shown potent in vitro activity against various influenza strains, including H5N1 [6]. Group 3: Future Directions - Ongoing animal model studies are assessing the impact of a single dose of tivoxavir marboxil on lethal bird flu infection, supporting its further development as a one-time treatment for bird flu [6]. - The combined clinical and animal model data will guide upcoming regulatory meetings as the company advances this product [3].

Core Insights - Expert Systems and Traws Pharma have achieved a significant milestone in the development of Tivoxavir Marboxil, an antiviral drug targeting H5N1 avian influenza, which shows promise as a single-dose treatment [1][2][5] Company Overview - Traws Pharma, Inc. is a clinical-stage biopharmaceutical company focused on developing oral small molecule therapies for respiratory viral diseases and cancer, utilizing expertise in small molecule chemistry and artificial intelligence [6] - Expert Systems is a leader in drug discovery and development, combining advanced machine learning algorithms with domain expertise to accelerate the development of innovative therapies for critical medical needs [7] Drug Development Progress - Tivoxavir Marboxil has demonstrated broad-spectrum efficacy against various flu strains, including drug-resistant and highly pathogenic avian influenza viruses, in preclinical studies [2] - A Phase 1 clinical trial showed that a single dose of Tivoxavir Marboxil maintained plasma drug levels above the effective concentration for over 23 days, indicating potential for sustained efficacy [3] - Following the successful completion of Phase 1 trials, plans are in place to initiate Phase 2 efficacy studies in the first half of 2025, moving closer to market availability [5] Expert Commentary - Dr. Robert R. Redfield, Chief Medical Officer of Traws Pharma, highlighted the increasing risk of avian influenza adapting to humans, emphasizing the need for vigilance against potential epidemic or pandemic spread [4] - Tudor Oprea, CEO of Expert Systems, noted the transformative potential of combining artificial intelligence with human expertise to address urgent global health challenges [5]