In an exciting development in the fight against COVID-19, Traws Pharma, Inc. (NASDAQ: TRAW) announced promising interim results from a mid-stage clinical trial of its experimental treatment, ratutrelvir. This new oral antiviral may provide a viable alternative to Paxlovid, boasting a better side effect profile and no instances of viral rebound observed thus far.
Trial Insights and Methodology
The findings stem from a pre-specified interim analysis of a Phase 2, randomized, open-label study designed to compare ratutrelvir with Paxlovid in patients suffering from mild-to-moderate COVID-19. The trial also features a group of patients who are ineligible for ritonavir-boosted therapies, a demographic often facing limited treatment options due to drug interactions or contraindications.
Ratutrelvir is engineered to inhibit the SARS-CoV-2 main protease without requiring ritonavir boosting. In this interim analysis, data from 37 participants were scrutinized, with 25 receiving ratutrelvir and 12 on Paxlovid. More than half of the targeted enrollment of 90 patients has been completed, indicating a robust pace for this critical research.
Patients treated with ratutrelvir received the medication once daily for 10 days, while those in the Paxlovid group adhered to a standard five-day regimen. Patient-reported outcomes, based on standardized symptom diaries, revealed that symptom reduction was numerically comparable between both groups. However, it is essential to note that the analysis was descriptive, and no formal statistical testing was performed.
Key Findings and Implications
A significant highlight from the interim results is the absence of symptom or virologic rebound events among those treated with ratutrelvir. In contrast, one rebound event was recorded in the Paxlovid group, accounting for 8.3 percent of that cohort. The concern of viral rebound has been a persistent issue for clinicians and patients utilizing existing oral antiviral medications.
Additionally, the interim data suggests that ratutrelvir has a more favorable safety and tolerability profile. Mild dyspepsia was the most frequently reported adverse effect, occurring in just two patients. Notably, no treatment discontinuations were necessary, and adverse effects typically associated with Paxlovid, such as taste disturbance and dizziness, were absent in the ratutrelvir group.
Among the six patients in the ratutrelvir cohort who were ineligible for Paxlovid due to contraindications or potential drug interactions, symptom improvement patterns aligned with those of the broader ratutrelvir-treated population. This finding indicates significant potential utility for this treatment in a demographic often excluded from antiviral therapies.
Company executives expressed optimism regarding the absence of viral rebound, improved tolerability, and extended dosing, which support further investigation of ratutrelvir. They are particularly interested in its potential implications for both acute COVID-19 treatment and its role in mitigating the risk of long COVID.
Final data from the study is anticipated to be reported in January 2026. Traws Pharma confirmed that enrollment and follow-up efforts are ongoing, emphasizing the need for larger datasets to ascertain definitive conclusions regarding efficacy and long-term outcomes.
This development marks a significant milestone in the ongoing battle against COVID-19, as researchers and healthcare professionals continue to seek effective treatments for patients worldwide.
