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."
Topline Phase 1 Results with Tivoxavir
Marboxil
The Phase 1 trial was a randomized, double-blind,
placebo-controlled study to assess the safety, tolerability, and
pharmacokinetics (PK) of ascending doses for one-time tivoxavir
marboxil treatment in healthy, influenza-negative, adult
volunteers.
No treatment-related adverse events were reported
during the Phase 1 study. Current topline data from this study
showed that a single dose of tivoxavir marboxil maintained plasma
drug levels consistently above the EC90 for more than
twenty-three days, with topline data for a higher dose still to
come. 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 H5N1 Bird Flu
The virus, also known as Type A H5N1 was detected
for the first time in U.S. dairy cattle in March 2024. Since then, bird flu has been
confirmed in at least 866 herds in 16 states. More than 60
people in eight states have been infected according to the U.S.
Centers for Disease Control and Prevention. Health officials
confirmed in December 2024 the first
known severe illness in the U.S. caused by bird flu7.
The California governor declared a
state of emergency as the virus rampages through dairy cattle in
that state8.
About Tivoxavir Marboxil
Seasonal
influenza is estimated to represent a 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 (also
known as AV5124 or TRX-100) 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, including the highly pathogenic avian
flu, in preclinical studies. The drug candidate's Phase 1
pharmacokinetic (PK) profile in healthy subjects, including the
ability to achieve plasma levels that are consistently above the
EC90 (as determined in laboratory studies), for more
than twenty-three days with higher dose data to come, may enable a
single dose prophylaxis regimen. These data, combined with good
overall tolerability results in healthy subjects and prevention of
lethal influenza in an animal model, support further development of
tivoxavir marboxil as a one-time treatment for influenza.
Source information:
- TRAW data on file
- Flu is burdensome
- Flu hospitalizations
- Flu mortality
- Flu in older adults
- Avian flu
- Bird flu CDC
- California
About Traws Pharma, Inc. Antiviral
Program
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 Pharma is committed to delivering novel
compounds for unmet medical needs using state-of-the-art drug
development technology. With a focus on product safety and a
commitment to patients in need that are specifically vulnerable, we
aim to build solutions for important medical challenges and
alleviate the burden of viral infections
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 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.
Traws Pharma Contacts:
Mark Guerin
Traws Pharma, Inc.
267-759-3680
www.trawspharma.com
View original
content:https://www.prnewswire.com/news-releases/traws-pharma-announces-progress-in-developing-tivoxavir-marboxil-for-h5n1-bird-flu-302338003.html
SOURCE Traws Pharma, Inc.