Full Press Release Details
Traws Pharma's Bird Flu Drug Candidate,
Tivoxavir Marboxil, Presented at ICAR
NEWTOWN, PA, March 21, 2025 (GLOBE NEWSWIRE)
- Traws Pharma, Inc. (NASDAQ: TRAW) ("Traws Pharma", "Traws" or "the Company"), a clinical-stage
biopharmaceutical company developing novel therapies to target critical threats to human health from respiratory viral diseases, today
announced that positive data supporting the potential for tivoxavir marboxil (TXM) as a bird flu treatment was presented yesterday in
a poster at the International Society for Antiviral Research (ICAR 2025), being held in Las Vegas, Nevada.
C. David Pauza, PhD, Chief Science Officer
of Traws Pharma commented, "Bird flu has emerged as a potential threat to human health. Extensive spread in poultry and dairy farms
have increased the exposure risk for agricultural workers. We believe an effective antiviral agent for bird flu needs to potently suppress
native and resistant viruses and provide protection against mortality and viral disease, with good overall tolerability and ease of use.
The positive data presented at ICAR, from laboratory, preclinical and Phase 1 studies, reinforce our view that TXM meets that target profile
and has the potential to be a potent, effective and safe treatment for bird flu, with broad applicability to seasonal flu. Looking ahead,
we plan to meet with the FDA to align on next steps, including the potential for an accelerated path to approval."
"We were pleased to have the opportunity
to share the promising TXM results in bird flu with the international antiviral community during the poster session at ICAR. We look forward
to updating investors on Traws' antiviral programs during a virtual event on Monday, March 31, 2025 at 10:00 AM ET,
said Werner Cautreels, PhD, Chief Executive Officer of Traws Pharma.
Tivoxavir Marboxil Poster
Poster Title: Tivoxavir
marboxil, an Influenza Inhibitor Targeting Cap-dependent Endonuclease: Results from a Phase I Trial Demonstrating Safety, Tolerability
and Pharmacokinetics and Demonstrating Protection Against H5N1 Bird Flu in a Rodent Challenge Model
Poster Date: March 20,
Data in the poster support potential use of
single dose treatment of TXM in bird flu:
The International Conference on Antiviral Research
(ICAR, https://www.isar-icar.com/ICAR2025) is international organization dedicated to bringing together scientists and clinicians from
multiple disciplines to discuss the latest advances and breakthroughs in antiviral
About Tivoxavir Marboxil
Tivoxavir marboxil (TXM) is an investigational
oral, small molecule CAP-dependent endonuclease inhibitor designed to be administered as a single-dose for the treatment of bird flu and
seasonal influenza. Consistent, positive preclinical data from three species indicate that a single-dose of TXM demonstrated a therapeutic
effect against H5N1 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 potential pandemic flu
outbreaks including H5N1 bird flu. We believe that these data support further development of tivoxavir marboxil as a treatment for bird
Source information: 1. TRAW data on file; 2. Mostafa, A., Barre,
R.S., Allue-Guardia, A., et al. (2025) Emerging Microbes and Infections, https://doi.org/10.1080/22221751.2024.2447614
About Traws Pharma, Inc.
Traws Pharma is a clinical stage biopharmaceutical
company dedicated to developing novel therapies to target critical threats to human health in respiratory viral diseases. We strive to
advance novel investigational antiviral agents that have potent activity against difficult to treat or resistant virus strains that threaten
human health. Our product candidates are intended to be safe, with simple dosing regimen. We seek to utilize accelerated clinical trial
strategies with a commitment to patients who are especially vulnerable.
The Company's two antiviral programs are
investigational oral small molecules targeting bird flu and seasonal influenza, and COVID-19. Tivoxavir marboxil is in development as
a single dose treatment for bird flu and seasonal influenza, targeting the influenza cap-dependent endonuclease (CEN). Ratutrelvir is
in development as a COVID treatment, targeting the Main protease (Mpro or 3CL protease), without the need for co-administration of ritonavir.
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, effectiveness, safety, 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 and pathways for approval, 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:
LifeSci Advisors, LLC