On December 23, 2024, Traws Pharma, Inc. (NASDAQ: TRAW) experienced a significant stock surge, rising over 200% during the trading session.
This increase was primarily due to the company's announcement of positive Phase 1 clinical trial results for its investigational treatment, tivoxavir marboxil, aimed at combating the H5N1 bird flu.
The trial demonstrated that a single dose of tivoxavir marboxil maintained plasma drug levels above the effective concentration for over 23 days, with no reported treatment-related adverse events.
Preclinical studies also indicated the drug's efficacy against drug-resistant influenza and highly pathogenic bird flu viruses.
The growing concern over H5N1, especially with its detection in U.S. dairy cattle and human infections, has heightened the demand for effective treatments.
Traws Pharma's progress with tivoxavir marboxil positions the company as a potential key player in addressing this public health threat, contributing to the stock's substantial rise on that date.
Traws Pharma Inc. (TRAW)
$8.67
-$0.34(-3.83%)January 2
Traws Pharma, Inc. (NASDAQ: TRAW) has announced plans to commence a Phase 2 clinical trial for tivoxavir marboxil, their investigational one-dose influenza therapy targeting H5N1 bird flu, in the first half of 2025.
This decision follows positive topline results from a Phase 1 study, which demonstrated that a single dose of tivoxavir marboxil maintained plasma drug levels above the effective concentration (EC90) for more than 23 days, with no treatment-related adverse events reported.
Preclinical studies have also shown that tivoxavir marboxil exhibits potent inhibition of drug-resistant influenza viruses and highly pathogenic bird flu viruses, both in vitro and in vivo.
The upcoming Phase 2 study aims to further evaluate the efficacy and safety of tivoxavir marboxil in a larger cohort, bringing the therapy closer to potential approval and availability for addressing the H5N1 bird flu threat.
Traws Pharma has secured financing of up to $72.6 million from leading healthcare institutional investors to support the advancement of tivoxavir marboxil's development through to approval.
This funding is expected to extend the company's cash runway into the first half of 2026, enabling them to reach both near-term and long-term value-inflecting milestones.
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 or that are specifically vulnerable.
They aim to build solutions for important medical challenges and alleviate the burden of viral infections.
The company's progress with tivoxavir marboxil positions them as a potential key player in addressing the public health threat posed by H5N1 bird flu.
The successful development of this therapy could provide a valuable resource in case of an avian flu outbreak or a pandemic, and for potential use to prevent virus spread in households and congregant settings.
Investors and stakeholders are advised to monitor Traws Pharma's announcements for updates on the Phase 2 trial's initiation and subsequent results, as these developments will be crucial in determining the future trajectory of tivoxavir marboxil and its role in combating H5N1 bird flu.
For more detailed information, please refer to Traws Pharma's official press releases and filings with the U.S. Securities and Exchange Commission (SEC).
