Traws Pharma Announces Progress in Developing Tivoxavir Marboxil for H5N1 Bird Flu

In This Article:

Investigational agent in development for treatment or prevention of H5N1 Bird Flu

Phase 1 dosing completed in healthy volunteers 

 Potent inhibition of drug-resistant and bird flu viruses in vitro

In vivo study in mice, with H5N1 isolated from an infected dairy worker, showed potent protection and suppression of virus replication in lungs

Phase 2 study expected to begin in H1 2025

Traws Pharma is expanding its influenza program to address the potential threat of bird flu

NEWTOWN, Pa., Dec. 23, 2024 /PRNewswire/ -- Traws Pharma, Inc. (NASDAQ: TRAW) ("Traws Pharma", "Traws" or "the Company"), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of respiratory viral diseases, today announced progress in the development of its investigational one-dose influenza (flu) investigational therapy, tivoxavir marboxil for treatment of H5N1 bird flu.

"The spread of avian influenza in wild and domestic animal populations including mammals, brings increasing risk for adaptation to humans and subsequent spread in the population" said Robert R. Redfield, MD, Chief Medical Officer for Traws Pharma and former Director of the U.S. Centers for Disease Control and Prevention (CDC). "Bird flu is an occupational hazard for poultry and dairy workers. With increasing numbers of human infections and recent reports of severe cases, we should be alert to the rising potential for epidemic or pandemic spread of bird flu."

"In laboratory testing, tivoxavir marboxil inhibited multiple isolates of highly pathogenic avian influenza H5N1. We evaluated the effects of drug treatment in mice exposed to human H5N1, where the virus was isolated from a dairy worker exposed to infected cattle," said C. David Pauza, PhD, Chief Science Officer for Traws Pharma. "Oral treatment with tivoxavir marboxil after the virus infection resulted in complete survival and lung virus levels below the limit of quantitation1. This result is highly encouraging for future clinical development of tivoxavir marboxil for treating human H5N1 influenza."

"Current topline data from our Phase I clinical trial demonstrated safety and tolerability of tivoxavir marboxil, and maintenance of drug levels in blood above the EC90 for longer than 23 days1, with topline data for a higher dose still to come," said Werner Cautreels, PhD, Chief Executive Officer of Traws Pharma. "In addition, the potential for tivoxavir marboxil as a treatment for H5N1 bird flu was demonstrated in an animal model."