Traws Pharma Announces Interim Data on Ratutrelvir

Traws Pharma announced that interim data with ratutrelvir, an investigational oral, ritonavir-free Mpro/3CL protease inhibitor, demonstrated a differentiated clinical profile in a pre-specified interim analysis of an ongoing randomized, open-label Phase 2 clinical study in patients with mild-to-moderate COVID-19. The study was designed as an active-controlled comparator trial versus paxlovid and evaluated patient-reported symptom outcomes, safety, and real-world usability. A separate treatment arm included patients ineligible for ritonavir-boosted regimens due to contraindications or clinically significant drug-drug interactions. To date, 37 patients have been included in the interim analysis, with 25 patients treated with ratutrelvir and 12 patients treated with paxlovid. More than 50% of the planned 90-patient population has been enrolled. Patients in the ratutrelvir arm received ratutrelvir 600 mg orally once daily for 10 days, while patients in the comparator arm received paxlovid administered as nirmatrelvir 300 mg plus ritonavir 100 mg twice daily for 5 days, consistent with approved prescribing information. "From a clinical perspective, these interim data suggest that ratutrelvir may provide a meaningful benefit across a broader range of patients, including those who are unable to receive ritonavir-boosted therapy," commented Robert Redfield, MD, Chief Medical Officer, Traws Pharma. "The favorable tolerability profile observed to date, together with the absence of viral rebound events in ratutrelvir-treated patients, is encouraging. While these findings are preliminary and descriptive, they support continued clinical evaluation of ratutrelvir in both acute COVID-19 and in studies designed to better understand its potential impact on longer-term outcomes."