NEWTOWN, PA — Traws Pharma, Inc. (NASDAQ: TRAW) has reported encouraging topline results from its Phase 1 trial of ratutrelvir, an oral inhibitor designed to combat COVID-19. The trial demonstrated favorable safety outcomes and effective plasma drug levels, positioning ratutrelvir as a potential leading therapy in the fight against COVID-19.
Ratutrelvir, tested as a monotherapy over a 10-day period in healthy volunteers, showed no treatment-related adverse events. The drug achieved consistent plasma concentrations well above the EC90 level for various SARS-CoV-2 strains, eliminating the need for ritonavir co-administration. This feature distinguishes ratutrelvir from current treatments like Paxlovid™, which requires ritonavir, often associated with adverse drug interactions.
Werner Cautreels, PhD, CEO of Traws Pharma, highlighted the drug’s potential: “These data provide us with further indication that ratutrelvir has the potential to be a potent, best-in-class, once-a-day antiviral therapy for COVID.” The company has slated a Phase 2a study to begin in the first half of 2025, refining the dose based on Phase 1 findings.
The urgency for new COVID therapies persists, as noted by Robert R. Redfield, MD, Chief Medical Officer at Traws Pharma: “Despite the wide availability of approved antiviral therapies, COVID was a major cause of mortality in the US in 2023.” Redfield emphasized the need for simple, effective treatments for at-risk populations, including older adults and those with underlying health conditions.
C. David Pauza, PhD, Chief Scientific Officer, added insight into ratutrelvir’s effectiveness, stating, “Preclinical studies showed that ratutrelvir monotherapy has differentiated activity compared to nirmatrelvir against drug-resistant viruses.” The drug’s pharmacokinetic profile also suggests a reduced risk of clinical rebound, a key concern with current COVID therapies.
The Phase 1 trial, conducted in Australia, was a randomized, double-blind, placebo-controlled study involving 56 healthy volunteers. It assessed safety, tolerability, and pharmacokinetics across various dosing regimens. The outcomes revealed no adverse effects and maintained drug levels within the therapeutic window.
Traws Pharma’s promising results pave the way for further clinical studies aimed at delivering a more accessible and effective treatment option.
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