Phase I completed in healthy volunteers with
pharmacokinetic data supporting dosing for both therapeutic and
further development for bird flu prevention
NEWTOWN,
Pa., Jan. 23, 2025 /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 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."
Topline Phase I Results
The Phase I 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 I 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.
Source information:
- TRAWS data on file
-
https://www.cdc.gov/media/releases/2025/m0106-h5-birdflu-death.html
-
http://dx.doi.org/10.15585/mmwr.mm7344a3
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 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.
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 required
by law.
Traws Pharma Contact:
Mark Guerin
Traws Pharma, Inc.
267-759-3680
www.trawspharma.com
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SOURCE Traws Pharma, Inc.