NEWTOWN, Pa., Oct. 06, 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 appointment of John Leaman, MD, to its board of directors as an independent director, effective October 1, 2025. In addition, Traws’ Board of Directors (the “Board”) has eliminated the interim notation of its key executi ...

Core Viewpoint - Traws Pharma is advancing the development of ratutrelvir, a ritonavir-free treatment for COVID-19, through two Phase 2 trials aimed at evaluating its safety and efficacy compared to PAXLOVID®, with top-line data expected by the end of 2025 [1][2][3]. Group 1: Company Overview - Traws Pharma, Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapies for respiratory viral diseases, including COVID-19 and Long COVID [6]. - The company integrates antiviral drug development with medical intelligence and regulatory strategy to address challenges in treating viral diseases [6]. Group 2: Product Development - Ratutrelvir is an investigational oral small molecule Mpro (3CL protease) inhibitor designed to treat SARS-CoV-2 without the need for ritonavir, potentially avoiding drug-drug interactions [3]. - Preclinical and Phase 1 studies indicate that ratutrelvir maintains target blood plasma levels significantly above the effective concentration, which may reduce the likelihood of clinical rebound and Long COVID [3]. Group 3: Market Context - In Q2 2025, Pfizer reported $427 million in sales for PAXLOVID®, marking a 70% increase from the same period the previous year, highlighting the ongoing demand for effective COVID-19 treatments [2]. - The rapid emergence of new viral variants, such as NB.1.8.1, which now accounts for 40% of COVID cases, underscores the need for effective antiviral therapies [2]. Group 4: Clinical Trials - The first trial will compare ratutrelvir against PAXLOVID® in newly diagnosed COVID patients, while a second trial will focus on PAXLOVID®-ineligible patients, a vulnerable group with limited treatment options [1][2]. - Results from both Phase 2 studies are anticipated by the end of 2025, which could provide critical proof-of-concept data for ratutrelvir [2].

Core Insights - RedHill Biopharma has received a critical composition-of-matter patent for RHB-107, enhancing its market exclusivity in the COVID-19 therapeutic space, which is projected to exceed $3 billion by 2025 [1][2] - RHB-107 has shown promising results in a U.S. Phase 2 study, achieving a 100% reduction in hospitalization rates among treated patients compared to a 15% hospitalization rate in the placebo group [2] - The drug is designed to be a broad-acting antiviral that targets human serine proteases, potentially effective against various SARS-CoV-2 variants [3][4] Company Overview - RedHill Biopharma focuses on the development and commercialization of drugs for gastrointestinal diseases, infectious diseases, and oncology, with a notable product being Talicia for H. pylori infection [5] - The company has a diverse pipeline, including RHB-204 for Crohn's disease and opaganib for cancer and COVID-19, indicating a strong commitment to addressing multiple health challenges [5] Clinical Data - In the Phase 2 study, RHB-107 demonstrated a 100% reduction in hospitalization (0/41) versus 15% (3/20) in the placebo group, with a nominal p-value of 0.0317, and an 88% reduction in new severe COVID-19 symptoms [2] - The study also indicated faster recovery times, with a median recovery of 3 days for RHB-107 compared to 8 days for placebo [2] Patent and Market Position - The newly allowed patent in China strengthens RedHill's intellectual property portfolio and expands its presence in Asia, a significant pharmaceutical market [2] - RHB-107's unique mechanism of action, targeting host cells rather than the virus directly, positions it as a potential alternative to existing treatments like Pfizer's Paxlovid [2][3]

Core Viewpoint - Traws Pharma, Inc. has presented positive data for ratutrelvir, a main protease inhibitor, as a potential treatment for COVID-19, highlighting its advantages over current therapies, particularly the lack of need for co-administration with ritonavir [1][2][4]. Company Overview - Traws Pharma is a clinical-stage biopharmaceutical company focused on developing novel therapies for respiratory viral diseases, including COVID-19 [9][10]. - The company aims to create safe antiviral agents with simple dosing regimens to address critical health threats [9]. Product Development - Ratutrelvir is designed to be an oral, small molecule Mpro (3CL protease) inhibitor that can be used without ritonavir, potentially avoiding drug-drug interactions and expanding patient eligibility [7][10]. - Preclinical and Phase 1 studies indicate that ratutrelvir maintains therapeutic blood levels significantly above the effective concentration (EC50) and does not require a metabolism inhibitor [5][7]. Clinical Data - Data from Phase 1 studies demonstrate excellent safety and tolerability for ratutrelvir, with a selected Phase 2 dosing regimen of 600 mg/day for 10 days showing promising pharmacokinetics [6][7]. - Laboratory studies confirm that ratutrelvir effectively suppresses replication of various SARS-CoV-2 strains, including Omicron variants, and maintains blood plasma levels above the EC90 [5][6]. Future Plans - Traws Pharma is preparing to engage with the FDA to discuss the path forward for ratutrelvir and plans to initiate Phase 2 studies [4][6]. - An Investor Event is scheduled for March 31, 2025, to present an overview of preclinical and human data on ratutrelvir [4][6].

Core Viewpoint - Traws Pharma, Inc. has presented positive data for ratutrelvir, a main protease inhibitor, as a potential treatment for COVID-19, highlighting its advantages over current therapies, particularly the lack of need for co-administration with ritonavir [1][2][4]. Company Overview - Traws Pharma is a clinical-stage biopharmaceutical company focused on developing novel therapies for respiratory viral diseases, including COVID-19 [9][10]. - The company aims to create safe antiviral agents with simple dosing regimens and is committed to accelerated clinical trial strategies [9]. Product Development - Ratutrelvir is designed to be an oral, small molecule Mpro inhibitor that can be used without ritonavir, potentially avoiding drug-drug interactions and expanding patient eligibility [7][10]. - Preclinical and Phase 1 studies indicate that ratutrelvir maintains blood plasma levels approximately 13 times above the EC50, which may reduce the likelihood of clinical rebound and long COVID [7][6]. Clinical Data - Data presented at the International Conference for Antiviral Research (ICAR 2025) demonstrated that ratutrelvir effectively suppressed replication of 18 different SARS-CoV-2 strains, including Omicron variants [2][5]. - Phase 1 results showed excellent safety and tolerability, with a selected Phase 2 dosing regimen of 600 mg/day for 10 days [3][6]. Future Plans - The company is preparing to engage with the FDA to discuss the path forward for ratutrelvir and plans to initiate Phase 2 studies [4][2]. - An Investor Event is scheduled for March 31, 2025, to present an overview of preclinical and human data on ratutrelvir [4][2].