Traws Pharma Reports Positive Phase 1 Results for Influenza Therapy Tivoxavir Marboxil

Traws Pharma

NEWTOWN, PA — Traws Pharma, Inc. (NASDAQ: TRAW) has announced promising topline results from its Phase 1 study of tivoxavir marboxil, an investigational one-dose influenza treatment. Designed to inhibit the CAP-dependent endonuclease (CEN) protein, tivoxavir is aimed at combating a broad spectrum of flu strains, including drug-resistant and bird flu viruses.

Werner Cautreels, PhD, CEO of Traws Pharma, reported that the Phase 1 study demonstrated tivoxavir’s good tolerability and favorable pharmacokinetic profile in healthy volunteers. “A single dose of tivoxavir maintained plasma drug levels above the EC90 for more than five days,” Cautreels stated, highlighting its potential as a one-time flu treatment. He also emphasized tivoxavir’s efficacy against drug-resistant strains and its impending Phase 2 clinical trials in early 2025.

Robert R. Redfield, MD, Chief Medical Officer of Traws Pharma and ex-CDC Director, underscored the urgency for new antiviral options, given the public health challenge posed by influenza in the United States. “The need for novel therapeutics is especially critical amidst bird flu risks,” Redfield said, reinforcing tivoxavir’s potential to curb virus spread in community settings.

C. David Pauza, PhD, Chief Science Officer, emphasized tivoxavir’s broad-spectrum activity. “We are pleased that tivoxavir showed robust activity against drug-resistant and highly pathogenic strains like avian flu,” Pauza noted. He also pointed to tivoxavir’s enhanced lung uptake as a critical feature, achieving significant accumulation compared to plasma levels.

The Phase 1 trial was a randomized, double-blind, placebo-controlled study evaluating tivoxavir’s safety and pharmacokinetics in influenza-negative adults. No treatment-related adverse events were observed, and the drug successfully maintained therapeutic plasma levels beyond five days, supporting the selection of doses for future studies.

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Traws Pharma’s announcement marks a significant step forward in developing effective, one-dose treatments to address both seasonal and pandemic influenza threats, offering hope for improved public health management.

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