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[1]
Expert Systems and Traws Pharma Report Breakthrough in H5N1Bird Flu Antiviral Program
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.
[2]
Expert Systems and Traws Pharma Report Breakthrough in H5N1Bird Flu Antiviral Program By Investing.com
, /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. , Chief Medical (TASE:PMCN) 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 , 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.
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Expert Systems and Traws Pharma report significant progress in developing Tivoxavir Marboxil, a single-dose antiviral treatment for H5N1 avian influenza. The AI-enabled drug discovery process has yielded promising results in Phase 1 clinical trials, potentially revolutionizing bird flu treatment.
Expert Systems, a hybrid AI-enabled drug discovery and development accelerator, has announced a significant breakthrough in the development of an H5N1 bird flu antiviral treatment. In collaboration with Traws Pharma, Inc. (NASDAQ: TRAW), the company has reported encouraging results for their investigational drug, Tivoxavir Marboxil, which shows potential as a single-dose treatment for H5N1 avian influenza 12.
Tivoxavir Marboxil is an oral cap-dependent endonuclease inhibitor that targets a highly conserved influenza protein. This approach has demonstrated broad-spectrum efficacy against various flu strains, including avian influenza. Preclinical studies have shown potent activity against drug-resistant and highly pathogenic bird flu viruses, both in vitro and in vivo 12.
A recent randomized, double-blind, placebo-controlled Phase 1 clinical trial evaluated the safety, tolerability, and pharmacokinetics of single ascending doses of Tivoxavir Marboxil in healthy, influenza-negative adult volunteers. The trial reported no treatment-related adverse events, a crucial milestone in drug development. Notably, a single dose maintained plasma drug levels above the effective concentration (EC90) for over 23 days, suggesting the potential for sustained efficacy with just one administration 12.
Dr. Robert R. Redfield, Chief Medical Officer for Traws Pharma and former Director of the U.S. Centers for Disease Control and Prevention (CDC), emphasized the increasing risk of bird flu adaptation to humans. He stated, "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" 12.
Expert Systems has played a crucial role in the ideation, design, incubation, and support of this program. The company's hybrid human and AI-based drug discovery, development, and venture studio startup services platform has been instrumental in expediting the development of this innovative therapy. This collaboration highlights the effectiveness of integrating artificial intelligence with human expertise and computer-aided drug design and business management 12.
Tudor Oprea, Chief Executive Officer of Expert Systems, commented on the breakthrough: "The success of Tivoxavir Marboxil underscores the transformative potential of combining artificial intelligence with human expertise to tackle urgent global health challenges. We are excited to support Traws Pharma in bringing this innovative flu treatment closer to market" 12.
With the successful completion of Phase 1 trials, plans are underway to initiate Phase 2 efficacy studies in the first half of 2025. This progress brings Tivoxavir Marboxil closer to becoming a viable treatment option for H5N1 bird flu, addressing a critical need in global health 12.
As the development of Tivoxavir Marboxil continues, it represents a significant step forward in the fight against avian influenza and showcases the potential of AI-driven drug discovery to address urgent global health challenges.
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