Traws Pharma, Inc. a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of respiratory viral diseases, today announced completion of Phase I clinical studies of its investigational one-dose influenza (flu) therapy, tivoxavir marboxil (tivoxavir), for the treatment or prevention of H5N1 bird flu.

"We believe that our clinical data in healthy volunteers support accelerated development of tivoxavir marboxil in response to the growing threat of bird flu," said Werner Cautreels, PhD, Chief Executive Officer of Traws Pharma.

"The first U.S. death from the bird flu2 and the spread into commercial poultry farms highlight a growing threat to public health," 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). "We believe that new antiviral therapies, with proven activity against the H5N1 bird flu, are needed to address this potential threat. Continued circulation of this H5N1 virus in wild birds and mammals, plus spread of the virus from cattle or poultry to agricultural workers, sustains the risk for virus adaptation and human to human transmission.3"

"Topline data from the Phase I study demonstrated safety and tolerability of tivoxavir marboxil in humans at levels of exposure that have demonstrated potent inhibition of H5N1 and informs dose selections for further testing in relevant animal models of bird flu," said C. David Pauza, PhD, Chief Science Officer for Traws Pharma. "The combined clinical and animal model data package will guide our upcoming regulatory meetings as we advance this product and, hopefully, provide an important medical countermeasure against bird flu."

Seasonal influenza represents an estimated multi-billion antiviral market opportunity, largely driven by global health organizations, practice guidelines and government tenders1, with upside potential from pandemic flu outbreaks. Tivoxavir marboxil was designed as an inhibitor of the highly conserved influenza protein, CAP-dependent endonuclease (CEN). It has demonstrated potent in vitro activity against a range of influenza strains in preclinical studies, including the highly pathogenic avian flu H5N1 (bird flu). Completed and ongoing animal model studies are assessing the impact of a single dose of tivoxavir marboxil on lethal bird flu infection. We believe that these data support further development of tivoxavir marboxil as a one-time treatment for bird flu.

Traws Pharma is a clinical stage biopharmaceutical company developing potential oral small molecule therapies for the treatment of respiratory viral diseases. The viral respiratory disease program includes two oral, novel, Phase I, potentially best-in-class, small molecule drug candidates: tivoxavir marboxil, in development for flu and pandemic flu, targeting the influenza cap-dependent endonuclease (CEN); and ratutrelvir, in development as a COVID treatment, targeting the Mpro (3CL protease), without the need for co-administration of ritonavir.

 

Source: prnewswire.com

Report Abuse