A phase 1 trial of the investigational therapy for H5N1 bird flu showed promising safety, tolerability, and pharmacokinetic results, with the company securing financing to advance its development.
RT’s Three Key Takeaways:
- Positive Phase 1 Results: Tivoxavir marboxil demonstrated safety and tolerability in a phase 1 clinical trial for H5N1 bird flu, supporting further development of the therapy.
- Strong Preclinical Evidence: The investigational therapy has shown potent inhibition of drug-resistant influenza viruses and H5N1 in both preclinical studies and animal models.
- Securing Funding for Advancement: The company has entered an agreement to raise up to $72.6 million to support the continued development of tivoxavir marboxil, with key data readouts expected in early 2025.
Clinical-stage biopharmaceutical company Traws Pharma Inc announced topline phase 1 clinical trial results for its investigational one-dose influenza investigational therapy, tivoxavir marboxil, being developed for the treatment of H5N1 bird flu.
The phase 1 trial was a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and pharmacokinetics 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 23 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 viruses both in vitro and in vivo.
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, according to a release from Traws Pharma.
“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,” says Robert R. Redfield, MD, chief medical officer for Traws Pharma and former director of the US Centers for Disease Control and Prevention, in a release. “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.”
The virus, also known as type A H5N1 was detected for the first time in US 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 US Centers for Disease Control and Prevention. Health officials confirmed in December 2024 the first known severe illness in the US caused by bird flu. The California governor declared a state of emergency as the virus rampages through dairy cattle in that state.
Securing Financing to Advance Tivoxavir Marboxil for Bird Flu
Subsequently, Traws Pharma announced that it entered into definitive agreements to raise up to $72.6 million before deduction of placement agent’s fees and other estimated offering expenses to advance tivoxavir marboxil development for H5N1 bird flu to approval.
The initial tranche of $20 million gross proceeds will come in at closing for the issuance and sale of an aggregate of 3,919,249.00 shares of common stock and pre-paid warrants and up to another $52.6 million upon exercise of non-prepaid warrants issued with the offering if exercised in full within 30 days of the later of the following key data readouts: ferret bird flu data and non-human primate bird flu data (both expected early-1Q25) and Phase 2A Data (expected-2H25).
“We are appreciative of the support from new and existing institutional investors including Perceptive Advisors, OrbiMed, Alyeska, Torrey Pines and Ikarian Capital. This financing by high quality investors is transformative for Traws and highlights the meaningful potential for tivoxavir marboxil,” says Iain D. Dukes, MA, DPhil, executive chairman of Traws Pharma and venture partner of OrbiMed.
Traws Pharma will host an update call on tivoxavir marboxil during the first quarter of 2025 with additional details forthcoming.
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