Traws Pharma, Inc. Announced positive results from a Phase 2 clinical study evaluating its novel oral COVID-19 treatment, ratutrelvir, against Paxlovid, while simultaneously reporting advancements and a clinical hold concerning its influenza treatment, tivoxavir marboxil. The ratutrelvir study, involving 90 patients with mild-to-moderate COVID-19, demonstrated a differentiated profile compared to Paxlovid, specifically showing fewer adverse events and no viral rebounds, particularly in patients who were unable to receive ritonavir-boosted treatments.
The findings indicate ratutrelvir may offer a safer treatment option for a significant patient population currently excluded from Paxlovid therapy. According to the company, ratutrelvir also showed promise in facilitating quicker symptom resolution in this group. The clinical analysis was completed as of February 19, 2026, according to a company statement.
Alongside the positive ratutrelvir data, Traws Pharma highlighted pre-clinical results for tivoxavir marboxil, an investigational treatment for seasonal influenza. These results suggest increased exposure levels, potentially enabling once-monthly oral administration for preventative use. Preparations for human clinical studies are underway. However, the Food and Drug Administration (FDA) has placed a clinical hold on the U.S. Investigational New Drug (IND) application for tivoxavir marboxil due to unspecified safety concerns.
Traws Pharma initially completed enrollment in the ratutrelvir clinical study in January 2026, concurrently announcing plans to explore tivoxavir marboxil as a prophylactic treatment for influenza. The company is focused on developing treatment options for respiratory viral diseases, emphasizing the potential of both ratutrelvir and tivoxavir marboxil.
The company did not provide a timeline for addressing the FDA’s clinical hold on tivoxavir marboxil, and the agency has not publicly commented on the specific safety concerns prompting the action.
