NEWTOWN, PA — Traws Pharma, Inc. (NASDAQ: TRAW) has unveiled promising preclinical and Phase 1 data for ratutrelvir, its investigational oral treatment for COVID-19. Presented at the International Conference for Antiviral Research (ICAR 2025) in Las Vegas on March 20, the findings highlight the drug’s potential to significantly simplify COVID-19 treatment while enhancing outcomes for patients.
Ratutrelvir, a main protease inhibitor, is designed to be administered without ritonavir, a metabolic booster commonly required in existing COVID-19 therapies. The absence of ritonavir could reduce drug-drug interaction risks and expand treatment eligibility for individuals with complex medical conditions.
“COVID continues to be a significant cause of mortality for older adults with underlying medical conditions and people who are immunocompromised,” said Dr. Robert R. Redfield, Chief Medical Officer at Traws Pharma and former CDC Director. “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.”
Key Findings
- Potent Effectiveness Against COVID-19 Strains: Ratutrelvir effectively suppressed replication of 18 SARS-CoV-2 strains, including nirmatrelvir-resistant variants and Omicron subtypes.
- Strong Pharmacokinetics Without Ritonavir: Phase 1 studies demonstrated that ratutrelvir maintains therapeutic blood levels without requiring a metabolic booster. At the target dose of 600 mg/day for 10 days, blood plasma levels were sustained at four times the EC90, with lasting suppression beyond treatment completion.
- Enhanced Safety and Tolerability: Single- and multiple-dose studies confirmed the drug’s safety, supporting its potential for broader patient eligibility.
- Potential to Address Long COVID: The 10-day treatment regimen aims to optimize viral suppression, potentially reducing rebound cases and the risk of long COVID.
Dr. C. David Pauza, Chief Science Officer at Traws Pharma, emphasized the drug’s potential impact on viral resistance and patient outcomes. “Recent publications cite a relationship between the probability of slow viral clearance being associated with higher risk for long COVID. Ratutrelvir suppressed replication of 18 different strains of SARS-CoV-2 in laboratory tests and did not require co-administration of ritonavir,” he said. “Additionally, patterns of drug resistance mutations in vitro using ratutrelvir are distinct from those seen with nirmatrelvir and ensitrelvir, underscoring its unique profile.”
Traws Pharma is advancing preparations for discussions with the FDA and plans to initiate Phase 2 clinical trials. “We believe ratutrelvir has the potential to be a highly differentiated, broadly active treatment for COVID,” said Dr. Werner Cautreels, CEO of Traws Pharma. “Preparations are underway to meet with the FDA to align on a path forward and initiate Phase 2 studies. We plan to host an Investor Event on March 31 to present further details on our data and strategy.”
With data supporting its safety, ease of use, and broad antiviral activity, ratutrelvir could become a critical tool in combating COVID-19, offering hope for improved treatment outcomes and expanded patient access.
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