Traws Pharma Inc. (NASDAQ:TRAW) on Wednesday shared interim data from an ongoing randomized, open-label Phase 2 with ratutrelvir, an investigational oral, ritonavir-free Mpro/3CL protease inhibitor.
The data demonstrated a differentiated clinical profile in a pre-specified interim analysis in patients with mild-to-moderate COVID-19.
The study was designed as an active-controlled comparator trial versus Pfizer Inc.’s (NYSE:PFE) Paxlovid (nirmatrelvir/ritonavir) and evaluated patient-reported symptom outcomes, safety, and real-world usability.
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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.
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.
Efficacy in Broad COVID-19-Infected Population
Across the interim analysis, ratutrelvir-treated patients demonstrated time-to-sustained symptom alleviation and resolution that was numerically comparable to Paxlovid-treated patients.
Sustained alleviation was defined as self-reported alleviation of all COVID-19 symptoms for four consecutive days.
At the time of analysis, not all patients had completed the full 28-day observation period, and no formal statistical comparisons were performed; findings are descriptive and non-inferential.
No COVID-19 symptom or virologic rebound events have been observed to date in ratutrelvir-treated patients.
One rebound event was observed in the Paxlovid comparator arm (1 of 12 patients; 8.3%), occurring shortly after completion of the standard 5-day dosing regimen.
Six patients (16.2% of the interim population; 24% of the ratutrelvir cohort) treated with ratutrelvir were ineligible for Paxlovid due to contraindications or drug–drug interaction risk.
These patients demonstrated patient-reported symptom improvement dynamics consistent with those observed in the broader ratutrelvir-treated cohort.
Ratutrelvir was well tolerated in the interim analysis, with fewer reported adverse events compared with the Paxlovid-treated cohort.
“The combination of early and sustained symptom improvement, extended dosing duration, absence of viral rebound observed to date, and favorable tolerability supports the strategic hypothesis that ratutrelvir may have utility in reducing post-acute sequelae of SARS-CoV-2 infection (Long COVID)”, commented Robert Redfield, Chief Medical Officer, Traws Pharma.
Price Action: TRAW stock is down 2.27% at $2.15 during the premarket session at the last check on Wednesday.
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