NEWTOWN, PA — Traws Pharma, Inc. (NASDAQ: TRAW) announced it has received approval from the Human Research Ethics Committee (HREC) to begin Phase 2 clinical trials of ratutrelvir, a ritonavir-free antiviral candidate for the treatment of COVID-19 in newly diagnosed patients.
The studies aim to evaluate ratutrelvir’s safety and efficacy compared to PAXLOVID®, the current standard of care, as well as its potential benefits for patients who cannot take ritonavir-containing therapies.
Two Phase 2 Studies Planned
The first trial is a non-inferiority study comparing ratutrelvir to PAXLOVID®, focusing on rates of infection, COVID-19 symptom resolution, disease rebound, and the development of Long COVID. A second single-arm study will assess ratutrelvir’s performance in PAXLOVID®-ineligible patients, a high-risk group with limited treatment options.
Top-line results from both studies are expected by the end of 2025.
Addressing Treatment Gaps
According to Interim CEO Iain D. Dukes, the trials represent a significant step toward offering a “best-in-class” alternative to existing antivirals. He noted that while Pfizer reported $427 million in PAXLOVID® sales for the second quarter of 2025—a 70% increase year-over-year—current therapies still leave critical needs unmet, particularly for patients excluded from ritonavir-based treatments.
Chief Medical Officer Dr. Robert R. Redfield emphasized that COVID-19 continues to pose serious risks, especially for elderly and immunocompromised individuals. Current treatments, he said, have limitations, including the potential for drug interactions and rebound infections. Ratutrelvir’s ritonavir-free formulation and once-daily, single-tablet dosing for 10 days could help reduce these risks and lower the likelihood of Long COVID.
Rising Variants, Renewed Urgency
Traws’ Chief Science Officer Dr. C. David Pauza highlighted the rapid spread of the NB.1.8.1 variant, which now accounts for roughly 40% of U.S. cases. With waning immunity and declining vaccination rates, effective antivirals are becoming increasingly important.
Ratutrelvir’s broad activity against multiple viral strains, including drug-resistant variants, positions it as a promising candidate for widespread adoption if trial results prove favorable.
The company expects that positive outcomes from these Phase 2 studies could represent a pivotal moment in the development of next-generation COVID-19 therapeutics.
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