Traws Pharma Completes First Cohort Dosed in Phase 1 Trial for COVID Therapy

Investigational travatrelvir demonstrated preclinical activity against multiple SARS-CoV-2 variants

Orally administered novel protease inhibitor does not require ritonavir co-administration

First-in-Human study to evaluate safety, tolerability and pharmacokinetics in healthy volunteers

Topline Phase 1 data and Phase 2 initiation expected in H2 2024

NEWTOWN, Pa., May 07, 2024 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (“Traws” or “Traws Pharma”), a clinical stage biopharmaceutical company developing oral small molecules for respiratory viral diseases and cancer, today announced that it completed dosing in the first cohort of the first-in-human Phase 1 study to evaluate travatrelvir (TRX01), an orally-available protease inhibitor, in development for treatment of COVID19. There have been no safety observations reported.

“COVID-19 remains a significant global health concern, with SARS-CoV-2 infections posing a leading cause of mortality, especially among individuals aged 65 and above,” stated Werner Cautreels, Ph.D., Chief Executive Officer of Traws Pharma. “Our mission at Traws is to develop novel agents to treat respiratory viral diseases. Subject to future study results, we believe that travatrelvir may represent a major potential advance in the treatment of SARS-CoV-2 and are thrilled to advance this program into the first human clinical studies. We expect to report topline data from the Phase 1 study in H2 2024, followed by the initiation of an international Phase 2 safety and efficacy study."

Robert R. Redfield, M.D., Chief Medical Officer of Traws Pharma and former director of the US Centers for Disease Control (CDC) added, “Travatrelvir has an exciting and unique profile. In preclinical trials, it is active against multiple SARS-CoV-2 variants, does not require ritonavir co-administration and has a pharmacokinetic profile that may enable a dosing regimen that reduces the likelihood of viral rebound. These qualities may enable travatrelvir to overcome some of the limitations reported with other treatments and position travatrelvir as a potential best-in-class agent. We are grateful for the collaboration of the clinical investigators, human volunteers, and study sites and hope that travatrelvir will represent a new treatment option for this deadly viral disease.”

About Travatrelvir, the Phase 1 Program and Planned Next Steps

Travatrelvir was designed as an inhibitor of the SARS-CoV-2 Mpro (3CL protease). It has demonstrated in vitro activity against the original strain of the virus as well as the delta and omicron variants and is more active than nirmatrelvir (Pfizer’s Mpro inhibitor) in preclinical studies. Also in preclinical studies, travatrelvir did not require co-administration with a human cytochrome P450 (CYP) inhibitor, such as ritonavir, and so it is expected to avoid associated drug:drug interactions, potentially permitting wider patient use. The drug candidate’s pharmacokinetic (PK) profile may enable a once daily, 10-day treatment regimen to reduce the likelihood of viral rebound. GLP toxicology studies did not identify adverse events (AEs) in animals at the doses being studied in the Phase 1 clinical trial.