NEWTOWN, PA — Traws Pharma, Inc. (NASDAQ: TRAW) has begun dosing participants in a Phase 2 clinical trial evaluating ratutrelvir, a ritonavir-free antiviral therapy for newly diagnosed COVID-19 patients. The study marks an important step in the company’s strategy to advance next-generation oral treatments with improved safety and accessibility.
“The first trial will enable Traws to compare ratutrelvir, a potential best in class ritonavir-free agent, against the current gold standard, PAXLOVID®,” said Iain D. Dukes, MA, DPhil, Chief Executive Officer of Traws Pharma. “This study will evaluate safety, as well as rates of infection, COVID symptoms, disease rebound and incidence of Long COVID. In addition, we will initiate a second trial to evaluate the safety and efficacy of ratutrelvir in PAXLOVID®-ineligible patients, a population at risk for poor outcomes from COVID infection with few available treatment options. Our expectation is to be able to report the results of both Phase 2 studies by year-end 2025.”
“Across the US, we see multiple signs that COVID continues to threaten public health, especially among elderly and vulnerable individuals,” said Robert R. Redfield, MD, Chief Medical Officer of Traws Pharma. “We believe that Traws’ ritonavir-free COVID therapeutic candidate, ratutrelvir, has the potential to overcome the shortcomings of current treatments and become the new standard of care. Ratutrelvir’s good overall tolerability allows once-daily, single tablet dosing for 10 days, which could reduce the rate of rebound and the risk of Long COVID. Positive results could provide important proof-of-concept data and represent a valuable inflection point for the program.”
Ratutrelvir is an investigational oral small-molecule Mpro (3CL protease) inhibitor designed to treat SARS-CoV-2/COVID-19 without the use of ritonavir. Preclinical and Phase 1 studies show ratutrelvir achieves sustained blood plasma levels approximately 13 times above the EC50 using the Phase 2 dosing regimen of 600 mg per day for ten days. This may help reduce the risk of rebound infection and Long COVID.
By eliminating the need for ritonavir, which is known for drug-drug interactions, Traws Pharma aims to expand treatment eligibility for patients who cannot tolerate current regimens. If successful, ratutrelvir could compete in a multi-billion-dollar antiviral market while addressing persistent gaps in COVID-19 care.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.