Full Press Release Details
Traws Pharma Announces Completion of Phase I
studies with Tivoxavir marboxil, a single dose oral investigational drug for the treatment and prevention of H5N1 Bird Flu
Phase I completed in healthy volunteers with
pharmacokinetic data supporting dosing for both therapeutic and further development for bird flu prevention
NEWTOWN, PA, January 23, 2025 (PR NEWSWIRE) -
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 completion of Phase
1 clinical studies of its investigational one-dose influenza (flu) therapy, tivoxavir marboxil (tivoxavir), for the treatment or prevention
"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 highlights 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."
Topline Phase 1 Results
The Phase 1 trial was a randomized, double-blind,
placebo-controlled study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ascending doses of one-time
tivoxavir marboxil treatment in healthy, influenza-negative, adult volunteers.
No significant treatment related adverse events
were reported during the Phase 1 study, which evaluated four dose levels. Preclinical studies showed that tivoxavir marboxil demonstrated
potent inhibition of drug-resistant influenza viruses, as well as potent inhibition of highly pathogenic bird flu viruses1,
both in vitro and in vivo.
About Tivoxavir Marboxil
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.
About Traws Pharma, Inc. antiviral programs
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 1, 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.
Traws is committed to delivering novel compounds
for unmet medical needs using state-of-the-art drug development technology. With a commitment to patients in need and vulnerable populations,
we aim to build solutions for important medical challenges and alleviate the burden of viral infectious disease.
Forward-Looking Statements
Some of the statements
in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E
of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties
including statements regarding the Company, its business and product candidates, including the potential opportunity, benefits and the
regulatory plans for tivoxavir marboxil. The Company has attempted to identify forward-looking statements by terminology including
"believes", "estimates", "anticipates", "expects", "plans", "intends",
"may", "could", "might", "will", "should", "preliminary", "encouraging",
"approximately" or other words that convey uncertainty of future events or outcomes. Although Traws believes that the expectations
reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different
from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and
unknown risks, uncertainties, and other factors, including the success and timing of Traws' clinical trials, collaborations, market
conditions, regulatory requirements, the extent of the spread and threat of the bird flu, and those discussed under the heading "Risk
Factors" in Traws' filings with the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements contained
in this release speak only as of its date. Traws undertakes no obligation to update any forward-looking statements contained in this release
to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except to the extent
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