Traws Pharma Announces Progress in Developing Tivoxavir Marboxil for H5N1 Bird Flu
Traws Pharma (NASDAQ: TRAW) reported progress in developing tivoxavir marboxil for H5N1 bird flu treatment. The company completed Phase 1 dosing in healthy volunteers, demonstrating safety and drug level maintenance above EC90 for over 23 days. Preclinical studies showed potent inhibition of drug-resistant influenza and bird flu viruses both in vitro and in vivo.
In laboratory testing with mice exposed to H5N1 from an infected dairy worker, oral treatment resulted in complete survival and reduced lung virus levels. The company plans to begin Phase 2 studies in H1 2025. The development addresses growing concerns about bird flu adaptation to humans, particularly among poultry and dairy workers.
Traws Pharma (NASDAQ: TRAW) ha riportato progressi nello sviluppo di tivoxavir marboxil per il trattamento dell'influenza aviaria H5N1. L'azienda ha completato la somministrazione della Fase 1 su volontari sani, dimostrando la sicurezza e il mantenimento dei livelli del farmaco sopra EC90 per oltre 23 giorni. Gli studi preclinici hanno mostrato una potente inibizione dei virus dell'influenza resistente ai farmaci e dei virus dell'influenza aviaria sia in vitro che in vivo.
Nei test di laboratorio con topi esposti all'H5N1 da un lavoratore lattiero infetto, il trattamento orale ha portato a una sopravvivenza completa e a livelli ridotti di virus nei polmoni. L'azienda prevede di avviare studi di Fase 2 nella prima metà del 2025. Lo sviluppo affronta le crescenti preoccupazioni riguardo all'adattamento dell'influenza aviaria agli esseri umani, in particolare tra i lavoratori del settore avicolo e lattiero.
Traws Pharma (NASDAQ: TRAW) informó sobre avances en el desarrollo de tivoxavir marboxil para el tratamiento de la gripe aviar H5N1. La compañía completó la dosificación de la Fase 1 en voluntarios sanos, demostrando seguridad y mantenimiento de los niveles del fármaco por encima de EC90 durante más de 23 días. Los estudios preclínicos mostraron una potente inhibición de los virus de la gripe resistentes a fármacos y del virus de la gripe aviar tanto in vitro como in vivo.
En pruebas de laboratorio con ratones expuestos al H5N1 de un trabajador lechero infectado, el tratamiento oral resultó en una supervivencia completa y niveles reducidos de virus en los pulmones. La compañía planea iniciar estudios de Fase 2 en la primera mitad de 2025. El desarrollo aborda las crecientes preocupaciones sobre la adaptación de la gripe aviar a los humanos, particularmente entre los trabajadores de la avicultura y la industria láctea.
트로우스 파마 (NASDAQ: TRAW)는 H5N1 조류 독감 치료를 위한 티복사비르 마르복실 개발에서 진전을 보고했습니다. 이 회사는 건강한 자원봉사자들을 대상으로 1단계 투여를 완료하여, 안전성과 약물 수준이 23일 이상 EC90 이상으로 유지됨을 입증했습니다. 전임상 연구에서는 약물 저항성 인플루엔자 및 조류 독감 바이러스에 대해 테스트관과 생체 내에서 모두 강력한 억제 효과를 보여주었습니다.
감염된 유제품 노동자로부터 H5N1에 노출된 쥐를 대상으로 한 실험실 테스트에서 경구 치료는 완전한 생존과 폐 바이러스 수준 감소를 초래했습니다. 이 회사는 2025년 상반기 2단계 연구 시작을 계획하고 있습니다. 이 개발은 조류 독감이 인간에게 적응할 가능성에 대한 우려가 커지는 문제를 다루고 있으며, 특히 가금류와 유제품 노동자들 사이에서 더욱 두드러집니다.
Traws Pharma (NASDAQ: TRAW) a signalé des progrès dans le développement du tivoxavir marboxil pour le traitement de la grippe aviaire H5N1. L'entreprise a terminé l'administration de la Phase 1 sur des volontaires en bonne santé, démontrant la sécurité et le maintien des niveaux de médicaments au-dessus de EC90 pendant plus de 23 jours. Les études précliniques ont montré une inhibition puissante des virus de la grippe résistants aux médicaments et des virus de la grippe aviaire, tant in vitro qu'in vivo.
Lors des tests en laboratoire avec des souris exposées à l'H5N1 par un travailleur laitier infecté, le traitement oral a conduit à une survie totale et à des niveaux réduits de virus dans les poumons. L'entreprise prévoit de commencer les études de Phase 2 au premier semestre 2025. Le développement répond aux préoccupations croissantes concernant l'adaptation de la grippe aviaire aux humains, en particulier parmi les travailleurs de la volaille et des produits laitiers.
Traws Pharma (NASDAQ: TRAW) hat Fortschritte bei der Entwicklung von Tivoxavir Marboxil zur Behandlung der H5N1-Vogelgrippe gemeldet. Das Unternehmen hat die Dosierung der Phase 1 bei gesunden Probanden abgeschlossen und dabei die Sicherheit sowie die Aufrechterhaltung des Medikamentenspiegels über EC90 für mehr als 23 Tage nachgewiesen. Präklinische Studien zeigten eine starke Hemmung von medikamentenresistenten Influenza- und Vogelgrippeviren sowohl in vitro als auch in vivo.
In Laboruntersuchungen mit Mäusen, die von einem infizierten Milcharbeiter H5N1 ausgesetzt wurden, führte die orale Behandlung zu einer vollständigen Überlebensrate und reduzierten Virusspiegeln in der Lunge. Das Unternehmen plant den Beginn der Phase-2-Studien im ersten Halbjahr 2025. Die Entwicklung geht auf die wachsenden Bedenken bezüglich der Anpassung der Vogelgrippe an den Menschen ein, insbesondere bei Mitarbeitern aus der Geflügel- und Milchindustrie.
- Phase 1 trial showed no treatment-related adverse events
- Single dose maintained effective drug levels for over 23 days
- Complete survival rate in mouse studies with human H5N1
- Phase 2 study timeline established for H1 2025
- Higher dose trial data still pending
- Product still in early development stages with no revenue potential in near term
Insights
The completion of Phase 1 trials for tivoxavir marboxil represents a significant milestone in addressing H5N1 bird flu threats. The drug's ability to maintain plasma levels above EC90 for >23 days from a single dose is remarkable, suggesting potential for extended prophylaxis or treatment periods with minimal dosing requirements. This pharmacokinetic profile substantially differentiates it from existing antivirals.
The preclinical data showing efficacy against drug-resistant strains and complete survival in mouse models infected with human H5N1 isolates is particularly compelling. The ability to suppress viral replication below quantifiable limits in lung tissue indicates robust antiviral activity at the primary site of infection. Most notably, the drug's effectiveness against samples from an infected dairy worker demonstrates real-world applicability to zoonotic transmission scenarios.
The development timing is important given the increasing incidents of H5N1 spillover into mammals and humans. The drug's broad-spectrum activity against multiple H5N1 isolates suggests potential effectiveness against emerging variants. This addresses a critical gap in our pandemic preparedness arsenal, especially considering the concerning pattern of recent H5N1 infections in dairy workers.
For context, current H5N1 therapeutics have limitations in resistance profiles and administration routes. An oral, single-dose option with extended duration of action could revolutionize outbreak management strategies, particularly in high-risk occupational settings. The planned Phase 2 initiation in H1 2025 positions this development well within the accelerating timeline of H5N1 spread across species barriers.
Investigational agent in development for treatment or prevention of H5N1 Bird Flu
Phase 1 dosing completed in healthy volunteers
Potent inhibition of drug-resistant and bird flu viruses in vitro
In vivo study in mice, with H5N1 isolated from an infected dairy worker, showed potent protection and suppression of virus replication in lungs
Phase 2 study expected to begin in H1 2025
Traws Pharma is expanding its influenza program to address the potential threat of bird flu
"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" said Robert R. Redfield, MD, Chief Medical Officer for Traws Pharma and former Director of the
"In laboratory testing, tivoxavir marboxil inhibited multiple isolates of highly pathogenic avian influenza H5N1. We evaluated the effects of drug treatment in mice exposed to human H5N1, where the virus was isolated from a dairy worker exposed to infected cattle," said C. David Pauza, PhD, Chief Science Officer for Traws Pharma. "Oral treatment with tivoxavir marboxil after the virus infection resulted in complete survival and lung virus levels below the limit of quantitation1. This result is highly encouraging for future clinical development of tivoxavir marboxil for treating human H5N1 influenza."
"Current topline data from our Phase I clinical trial demonstrated safety and tolerability of tivoxavir marboxil, and maintenance of drug levels in blood above the EC90 for longer than 23 days1, with topline data for a higher dose still to come," said Werner Cautreels, PhD, Chief Executive Officer of Traws Pharma. "In addition, the potential for tivoxavir marboxil as a treatment for H5N1 bird flu was demonstrated in an animal model."
Topline Phase 1 Results with Tivoxavir Marboxil
The Phase 1 trial was a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and pharmacokinetics (PK) 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 twenty-three 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 viruses1 both in vitro and in vivo.
About H5N1 Bird Flu
The virus, also known as Type A H5N1 was detected for the first time in
About Tivoxavir Marboxil
Seasonal influenza is estimated to represent a multi-billion antiviral market opportunity, largely driven by global health organizations, practice guidelines and government tenders1, with upside potential from pandemic flu outbreaks. Tivoxavir marboxil (also known as AV5124 or TRX-100) was designed as an inhibitor of the highly conserved influenza protein, CAP-dependent endonuclease (CEN). It has demonstrated potent in vitro activity against a range of influenza strains, including the highly pathogenic avian flu, in preclinical studies. The drug candidate's Phase 1 pharmacokinetic (PK) profile in healthy subjects, including the ability to achieve plasma levels that are consistently above the EC90 (as determined in laboratory studies), for more than twenty-three days with higher dose data to come, may enable a single dose prophylaxis regimen. 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.
Source information:
- TRAW data on file
- Flu is burdensome
- Flu hospitalizations
- Flu mortality
- Flu in older adults
- Avian flu
- Bird flu CDC
California
About Traws Pharma, Inc. Antiviral Program
Traws Pharma is a clinical stage biopharmaceutical company developing potential oral small molecule therapies for the treatment of respiratory viral diseases. The viral respiratory disease program includes two oral, novel, Phase 1, potentially best-in-class, small molecule drug candidates: tivoxavir marboxil, in development for flu and pandemic flu, targeting the influenza cap-dependent endonuclease (CEN); and ratutrelvir, in development as a COVID treatment, targeting the Mpro (3CL protease), without the need for co-administration of ritonavir.
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 that are specifically vulnerable, we aim to build solutions for important medical challenges and alleviate the burden of viral infections
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties including statements regarding the Company, its business and product candidates, including the potential opportunity, benefits and the regulatory plans for tivoxavir marboxil. The Company has attempted to identify forward-looking statements by terminology including "believes", "estimates", "anticipates", "expects", "plans", "intends", "may", "could", "might", "will", "should", "preliminary", "encouraging", "approximately" or other words that convey uncertainty of future events or outcomes. Although Traws believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Traws' clinical trials, collaborations, market conditions and those discussed under the heading "Risk Factors" in Traws' filings with the
Traws Pharma Contacts:
Mark Guerin
Traws Pharma, Inc.
267-759-3680
www.trawspharma.com
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SOURCE Traws Pharma, Inc.
FAQ
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