Expert Systems and Traws Pharma Report Breakthrough in H5N1Bird Flu Antiviral Program
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.
Expert Systems e Traws Pharma (NASDAQ: TRAW) hanno annunciato significativi progressi nel loro programma antivirale contro l'influenza aviaria H5N1. Il loro farmaco in fase di studio, Tivoxavir Marboxil, ha mostrato risultati promettenti come trattamento a dose unica per l'influenza aviare. L'inibitore dell'enzima endonucleasi dipendente da RNA ha dimostrato un'efficacia a largo spettro contro diversi ceppi influenzali negli studi preclinici.
Nella Fase 1 degli studi clinici, il farmaco non ha mostrato eventi avversi correlati al trattamento e ha mantenuto livelli plasmatici efficaci per oltre 23 giorni con una dose singola. Il Dr. Robert R. Redfield, Chief Medical Officer di Traws Pharma e ex Direttore dei CDC, ha sottolineato il crescente rischio di adattamento dell'influenza aviaria all'uomo e la potenziale diffusione pandemica.
L'azienda prevede di avviare gli studi di efficacia di Fase 2 nella prima metà del 2025. Lo sviluppo sfrutta la piattaforma ibrida di scoperta di farmaci abilitata all'IA di Expert Systems, combinando intelligenza artificiale con competenza umana per accelerare lo sviluppo delle terapie.
Expert Systems y Traws Pharma (NASDAQ: TRAW) han anunciado avances significativos en su programa antivírico contra la gripe aviar H5N1. Su fármaco en investigación, Tivoxavir Marboxil, ha demostrado resultados prometedores como tratamiento de dosis única para la influenza aviar. El inhibidor de la endonucleasa dependiente de cap ha mostrado eficacia de amplio espectro contra diversas cepas de gripe en estudios preclínicos.
En los ensayos clínicos de Fase 1, el fármaco no mostró eventos adversos relacionados con el tratamiento y mantuvo niveles plasmáticos efectivos durante más de 23 días con una sola dosis. El Dr. Robert R. Redfield, Director Médico de Traws Pharma y ex Director de los CDC, enfatizó el creciente riesgo de adaptación de la gripe aviar a los humanos y la potencial propagación pandémica.
La compañía planea iniciar estudios de eficacia de Fase 2 en la primera mitad de 2025. El desarrollo aprovecha la plataforma híbrida de descubrimiento de fármacos habilitada por IA de Expert Systems, combinando inteligencia artificial con experiencia humana para acelerar el desarrollo de terapias.
Expert Systems와 Traws Pharma (NASDAQ: TRAW)는 H5N1 조류 인플루엔자 항바이러스 프로그램에서 중요한 진전을 발표했습니다. 그들의 연구 중인 약물인 Tivoxavir Marboxil은 조류 인플루엔자에 대한 단일 용량 치료로 유망한 결과를 보여주었습니다. 이 경구용 RNA 의존성 엔도뉴클레아제 억제제는 전임상 연구에서 다양한 독감 바이러스 균주에 대해 넓은 범위의 효능을 나타냈습니다.
1상 임상 시험에서는 약물이 치료와 관련된 부작용 없이 단일 용량으로 23일 이상 효과적인 혈장 농도를 유지했습니다. Traws Pharma의 최고 의료 책임자이자 전 CDC 이사인 Robert R. Redfield 박사는 조류 인플루엔자가 인체에 적응할 위험이 증가하고 있으며 잠재적인 팬데믹 확산의 가능성에 대해 강조했습니다.
회사는 2025년 상반기 내에 2상 효능 연구를 시작할 계획입니다. 이 개발은 Expert Systems의 하이브리드 AI 기반 약물 발견 플랫폼을 활용하여 인공지능과 인간의 전문성을 결합해 치료 개발을 가속화하고 있습니다.
Expert Systems et Traws Pharma (NASDAQ: TRAW) ont annoncé des avancées significatives dans leur programme antiviral contre la grippe aviaire H5N1. Leur médicament investigué, Tivoxavir Marboxil, a montré des résultats prometteurs en tant que traitement à dose unique pour l'influenza aviaire. L'inhibiteur de l'endonucléase dépendante de cap a démontré une efficacité à large spectre contre diverses souches de grippe lors d'études précliniques.
Lors des essais cliniques de Phase 1, le médicament n'a montré aucun effet indésirable lié au traitement et a maintenu des niveaux plasmatiques efficaces pendant plus de 23 jours avec une dose unique. Le Dr Robert R. Redfield, Directeur Médical de Traws Pharma et ancien Directeur des CDC, a souligné le risque croissant d'adaptation de la grippe aviaire chez les humains et son potentiel de propagation pandémique.
L'entreprise prévoit de lancer des études d'efficacité de Phase 2 au cours de la première moitié de 2025. Le développement s'appuie sur la plateforme hybride de découverte de médicaments habilitée par l'IA d'Expert Systems, qui combine l'intelligence artificielle avec l'expertise humaine pour accélérer le développement des thérapies.
Expert Systems und Traws Pharma (NASDAQ: TRAW) haben bedeutende Fortschritte in ihrem H5N1-Viren-Programm angekündigt. Ihr erforschtes Medikament, Tivoxavir Marboxil, hat vielversprechende Ergebnisse als Einmalbehandlung gegen die Vogelgrippe gezeigt. Der orale RNA-abhängige Endonuklease-Inhibitor hat in präklinischen Studien eine breite Wirksamkeit gegen verschiedene Grippevirusstämme gezeigt.
In Phase-1-Studien zeigte das Medikament keine behandlungsbedingten Nebenwirkungen und hielt über 23 Tage lang wirksame Plasmaspiegel mit einer Einzeldosis aufrecht. Dr. Robert R. Redfield, Chief Medical Officer von Traws Pharma und ehemaliger CDC-Direktor, wies auf das zunehmende Risiko hin, dass sich die Vogelgrippe an den Menschen anpasst und potenziell pandemisch verbreitet.
Das Unternehmen plant, im ersten Halbjahr 2025 Phase-2-Effektivitätsstudien zu starten. Die Entwicklung nutzt die hybride KI-gestützte Plattform von Expert Systems zur Arzneimittelentdeckung, die künstliche Intelligenz mit menschlichem Fachwissen kombiniert, um die Therapieentwicklung zu beschleunigen.
- 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
- Drug still in early development stages with no proven efficacy in humans yet
- Significant regulatory hurdles remain before potential market approval
Insights
The Phase 1 trial results for Tivoxavir Marboxil represent a significant breakthrough in antiviral development. The drug's ability to maintain plasma levels above EC90 for 23 days with a single dose is exceptionally rare in antiviral therapeutics. Most current antivirals require multiple doses over several days, making this single-dose approach potentially revolutionary for treatment compliance and effectiveness.
The cap-dependent endonuclease inhibitor mechanism is particularly clever - by targeting a highly conserved influenza protein, it reduces the likelihood of resistance development. Think of it as attacking the virus's unchanging core rather than its constantly mutating outer shell. The broad-spectrum activity against multiple flu strains, including drug-resistant variants, suggests robust therapeutic potential.
In simpler terms: Imagine having a master key that can unlock multiple doors (virus strains) versus carrying different keys for each door. That's what makes this drug special - one treatment could potentially work against many flu variants.
For a small-cap biotech company (
The partnership with Expert Systems, leveraging AI in drug development, potentially reduces R&D costs and accelerates time-to-market. This hybrid approach typically cuts traditional drug development timelines by
For everyday investors: Think of this as a small company potentially sitting on a powerful solution to a growing global threat. The successful Phase 1 results and upcoming Phase 2 trials are like checkpoints that could significantly increase the company's value if passed successfully.
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
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.
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
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