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RedHill Biopharma Secures Allowance of Key Chinese Patent Application for Proprietary COVID-19 Treatment, RHB-107
Prnewswire· 2025-04-28 11:03
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]
Traws Pharma's COVID-19 Candidate, Ratutrelvir, Presented at ICAR
GlobeNewswire News Room· 2025-03-25 11:30
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].
Traws Pharma's COVID-19 Candidate, Ratutrelvir, Presented at ICAR
Newsfilter· 2025-03-25 11:30
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].