Expert Systems and Traws Pharma Report Breakthrough in H5N1Bird Flu Antiviral Program

Rhea-AI Summary

Expert Systems and Traws Pharma (NASDAQ: TRAW) have announced significant progress in their H5N1 bird flu antiviral program. Their investigational drug, Tivoxavir Marboxil, has demonstrated promising results as a single-dose treatment for avian influenza. The oral cap-dependent endonuclease inhibitor has shown broad-spectrum efficacy against various flu strains in preclinical studies.

In Phase 1 clinical trials, the drug showed no treatment-related adverse events and maintained effective plasma levels for over 23 days with a single dose. Dr. Robert R. Redfield, Chief Medical Officer for Traws Pharma and former CDC Director, emphasized the increasing risk of bird flu adaptation to humans and potential pandemic spread.

The company plans to initiate Phase 2 efficacy studies in the first half of 2025. The development leverages Expert Systems' hybrid AI-enabled drug discovery platform, combining artificial intelligence with human expertise for expedited therapy development.

Positive

• Successful completion of Phase 1 trials with no treatment-related adverse events
• Single dose maintains effective drug levels for over 23 days
• Drug shows broad-spectrum efficacy against various flu strains
• Phase 2 trials planned for first half of 2025

Negative

• Drug still in early development stages with no proven efficacy in humans yet
• Significant regulatory hurdles remain before potential market approval

SAN DIEGO, Jan. 10, 2025 /PRNewswire/ -- Expert Systems, a hybrid AI enabled drug discovery and development accelerator, announced a significant milestone in a development of Traws Pharma, Inc. 's (NASDAQ: TRAW) H5N1 antiviral program. The investigational drug, Tivoxavir Marboxil, has shown encouraging results as a single-dose treatment for H5N1 avian influenza, representing a potentially pivotal advance in addressing this serious health challenge.

Tivoxavir Marboxil, an oral cap-dependent endonuclease inhibitor, targets a highly conserved influenza protein, demonstrating broad-spectrum efficacy against various flu strains, including avian influenza. Preclinical studies have highlighted its potent activity against drug-resistant and highly pathogenic bird flu viruses, both in vitro and in vivo.

In a recent randomized, double-blind, placebo-controlled Phase 1 clinical trial, the safety, tolerability, and pharmacokinetics of single ascending doses of Tivoxavir Marboxil were evaluated in healthy, influenza-negative adult volunteers. The trial reported no treatment-related adverse events. Notably, a single dose maintained plasma drug levels above the effective concentration (EC90) for over 23 days, indicating the potential for sustained efficacy with a one-time administration.

Dr. Robert R. Redfield, Chief Medical Officer for Traws Pharma and former Director of the U.S. Centers for Disease Control and Prevention (CDC), commented: "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. 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."

Expert Systems has been instrumental in the ideation, design, incubation, and support of this program, taking advantage of its hybrid human and AI-based drug discovery, development and venture studio startup services platform. This collaboration underscores the effectiveness of integrating artificial intelligence with human expertise and computer-aided drug design and business management, to expedite the development of innovative therapies.

"The success of Tivoxavir Marboxil underscores the transformative potential of combining artificial intelligence with human expertise to tackle urgent global health challenges," said Tudor Oprea, Chief Executive Officer of Expert Systems. "We are excited to support Traws Pharma in bringing this innovative flu treatment closer to market."

With the completion of Phase 1 trials, plans are underway to initiate Phase 2 efficacy studies in the first half of 2025. This brings Tivoxavir Marboxil closer to becoming a viable treatment option for H5N1 bird flu, addressing a critical need in global health.

About Traws Pharma
Traws Pharma, Inc. is a clinical-stage biopharmaceutical company dedicated to developing oral small molecule therapies for respiratory viral diseases and cancer. Leveraging expertise in small molecule chemistry, artificial intelligence, and streamlined development processes, Traws Pharma focuses on creating innovative medicines targeting critical health threats, including drug-resistant influenza viruses and avian flu.

https://www.trawspharma.com/

About Expert Systems
Expert Systems is a drug discovery and development accelerator and leader in computer-enabled discovery and development platforms, committed to advancing the development of innovative therapies that address critical unmet medical needs. Combining advanced machine learning algorithms with broad domain expertise, Expert Systems accelerates the development of life-saving treatments in infectious diseases, oncology, CNS, immunology and cardiometabolic diseases. The company's innovative approach is reshaping the future of therapeutics.

https://www.expertsystems.inc/

Media Contact:
Bill Farley
Chief Business Officer
bfarley@expertsystems.inc

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SOURCE Expert Systems, Inc.

FAQ

What are the Phase 1 trial results for Traws Pharma's (TRAW) Tivoxavir Marboxil?

The Phase 1 trial showed no treatment-related adverse events and maintained effective plasma drug levels for over 23 days with a single dose.

When will Traws Pharma (TRAW) begin Phase 2 trials for their H5N1 antiviral drug?

Traws Pharma plans to initiate Phase 2 efficacy studies in the first half of 2025.

What is the mechanism of action for TRAW's Tivoxavir Marboxil?

Tivoxavir Marboxil is an oral cap-dependent endonuclease inhibitor that targets a highly conserved influenza protein.

How long does TRAW's Tivoxavir Marboxil remain effective after a single dose?

A single dose maintains plasma drug levels above the effective concentration (EC90) for over 23 days.

What types of flu strains does TRAW's Tivoxavir Marboxil work against?

The drug demonstrates broad-spectrum efficacy against various flu strains, including drug-resistant and highly pathogenic bird flu viruses.