Traws Pharma Reports Positive Results from An Accepted Bird Flu Model for Anti-Viral Candidate, Tivoxavir Marboxil
Traws Pharma (NASDAQ: TRAW) has announced positive topline results from testing their antiviral candidate, tivoxavir marboxil, in ferrets infected with H5N1 bird flu. The single-dose treatment demonstrated disease suppression and reduced viral burden in lungs, consistent with previous December 2024 murine model results.
The study utilized the A/Texas/37/2024 H5N1 virus strain isolated from a Texas dairy worker. The ferret model, widely accepted for human influenza studies, showed increased survival rates and lower viral presence in lungs and nasal tissues.
The company plans to conduct additional testing in non-human primates, with data expected in Q1 2025. Traws Pharma aims to discuss accelerated approval with the FDA under the 'Animal Rule' and will host a Virtual Investor Update on March 31, 2025, to review the bird flu program in detail.
Traws Pharma (NASDAQ: TRAW) ha annunciato risultati preliminari positivi dai test del loro candidato antivirale, tivoxavir marboxil, su furetti infettati con l'influenza aviaria H5N1. Il trattamento a dose singola ha dimostrato di sopprimere la malattia e ridurre il carico virale nei polmoni, in linea con i risultati precedenti ottenuti nel modello murino di dicembre 2024.
Lo studio ha utilizzato il ceppo virale H5N1 A/Texas/37/2024 isolato da un lavoratore di una fattoria in Texas. Il modello del furetto, ampiamente accettato per gli studi sull'influenza umana, ha mostrato tassi di sopravvivenza aumentati e una presenza virale ridotta nei polmoni e nei tessuti nasali.
L'azienda prevede di condurre ulteriori test su primati non umani, con dati attesi nel primo trimestre del 2025. Traws Pharma mira a discutere l'approvazione accelerata con la FDA secondo la 'Animal Rule' e ospiterà un Aggiornamento Virtuale per gli Investitori il 31 marzo 2025, per rivedere il programma sull'influenza aviaria in dettaglio.
Traws Pharma (NASDAQ: TRAW) ha anunciado resultados positivos preliminares de las pruebas de su candidato antiviral, tivoxavir marboxil, en hurones infectados con la gripe aviar H5N1. El tratamiento de dosis única demostró suprimir la enfermedad y reducir la carga viral en los pulmones, de acuerdo con los resultados previos del modelo murino de diciembre de 2024.
El estudio utilizó la cepa de virus H5N1 A/Texas/37/2024 aislada de un trabajador lechero de Texas. El modelo de hurón, ampliamente aceptado para estudios de influenza humana, mostró tasas de supervivencia aumentadas y una menor presencia viral en los pulmones y tejidos nasales.
La empresa planea realizar pruebas adicionales en primates no humanos, con datos esperados en el primer trimestre de 2025. Traws Pharma busca discutir la aprobación acelerada con la FDA bajo la 'Animal Rule' y llevará a cabo una Actualización Virtual para Inversores el 31 de marzo de 2025, para revisar el programa de gripe aviar en detalle.
트로스 제약 (NASDAQ: TRAW)이 H5N1 조류 인플루엔자에 감염된 오소리에서 항바이러스 후보물질 티복사비르 마르복실의 긍정적인 초기 결과를 발표했습니다. 단일 투여 치료가 질병 억제 및 폐의 바이러스 부담 감소를 보여주었으며, 이는 2024년 12월의 이전 쥐 모델 결과와 일치합니다.
이번 연구는 텍사스의 유제품 노동자로부터 분리된 A/Texas/37/2024 H5N1 바이러스 균주를 사용했습니다. 인간 인플루엔자 연구에 널리 사용되는 오소리 모델은 생존율 증가와 폐 및 비강 조직에서의 낮은 바이러스 존재를 보여주었습니다.
회사는 비인간 영장류를 대상으로 추가 테스트를 수행할 계획이며, 데이터는 2025년 1분기에 예상됩니다. 트로스 제약은 '동물 규칙'에 따라 FDA와의 신속 승인을 논의할 계획이며, 2025년 3월 31일에 조류 인플루엔자 프로그램을 자세히 검토하기 위한 가상 투자자 업데이트를 개최할 것입니다.
Traws Pharma (NASDAQ: TRAW) a annoncé des résultats préliminaires positifs des tests de son candidat antiviral, tivoxavir marboxil, chez des furets infectés par la grippe aviaire H5N1. Le traitement à dose unique a démontré une suppression de la maladie et une réduction de la charge virale dans les poumons, conformément aux résultats précédents du modèle murin de décembre 2024.
L'étude a utilisé la souche virale H5N1 A/Texas/37/2024 isolée d'un travailleur laitier du Texas. Le modèle de furet, largement accepté pour les études sur la grippe humaine, a montré des taux de survie accrus et une présence virale réduite dans les poumons et les tissus nasaux.
L'entreprise prévoit de réaliser des tests supplémentaires sur des primates non humains, avec des données attendues au premier trimestre 2025. Traws Pharma vise à discuter d'une approbation accélérée avec la FDA dans le cadre de la 'Animal Rule' et organisera une mise à jour virtuelle pour les investisseurs le 31 mars 2025, afin de passer en revue le programme de grippe aviaire en détail.
Traws Pharma (NASDAQ: TRAW) hat positive vorläufige Ergebnisse aus Tests mit ihrem antiviralen Kandidaten Tivoxavir Marboxil bei mit H5N1-Vogelgrippe infizierten Frettchen bekannt gegeben. Die Einzeldosisbehandlung zeigte eine Krankheitsunterdrückung und reduzierte die Viruslast in der Lunge, was mit den vorherigen Ergebnissen des Mausmodells aus Dezember 2024 übereinstimmt.
Die Studie verwendete den H5N1-Virusstamm A/Texas/37/2024, der von einem Milchbauer in Texas isoliert wurde. Das Frettchenmodell, das allgemein für Studien zur menschlichen Influenza akzeptiert ist, zeigte erhöhte Überlebensraten und eine geringere Viruspräsenz in der Lunge und im Nasengewebe.
Das Unternehmen plant, zusätzliche Tests an nichtmenschlichen Primaten durchzuführen, mit Daten, die im ersten Quartal 2025 erwartet werden. Traws Pharma beabsichtigt, die beschleunigte Zulassung bei der FDA gemäß der 'Animal Rule' zu besprechen, und wird am 31. März 2025 ein virtuelles Investor-Update veranstalten, um das Programm zur Vogelgrippe im Detail zu überprüfen.
- Positive topline results in ferret H5N1 study
- Increased survival rates in animal testing
- Reduced viral burden in lungs and nasal tissues
- Consistent positive results across multiple animal models
- Potential accelerated FDA approval pathway
- Still in preclinical stage, requiring additional studies
- No human trial data available yet
- Timeline to market approval uncertain
Insights
Traws Pharma's positive preclinical results for tivoxavir marboxil against H5N1 bird flu represents a significant development in their clinical pipeline. The demonstration of efficacy in ferrets—an accepted animal model for human influenza—following previous positive murine model results establishes a consistent preclinical efficacy profile that strengthens their regulatory position.
The company's strategy to pursue FDA's "Animal Rule" pathway is particularly noteworthy. This regulatory mechanism allows approval based on animal efficacy studies when human trials aren't ethical or feasible, potentially accelerating the timeline to market significantly. With pending non-human primate data expected this quarter, Traws is positioning for regulatory discussions that could catalyze their development timeline.
What makes this announcement particularly timely is the escalating public health concern around bird flu, with increasing animal infections and human exposures creating urgency for effective countermeasures. The small-cap biotech (
Investors should note the upcoming Virtual Investor Update on March 31st as a critical near-term catalyst where management will likely outline regulatory strategy, development timelines, and potential commercialization scenarios that could significantly impact enterprise value.
The preclinical efficacy data from Traws Pharma's H5N1 study deserves close attention from a public health perspective. Their candidate tivoxavir marboxil demonstrated meaningful viral suppression in ferrets after a single oral dose—a critical advantage for any potential pandemic countermeasure. The ferret model is particularly valuable for influenza drug development as these animals develop human-like symptoms and transmit the virus similarly to humans.
What's technically impressive is that the drug showed dual benefits: increased survival rates and reduced viral burden in both lung and nasal tissues. This suggests potential effectiveness in both preventing severe disease and possibly reducing transmission—though the latter would require additional specific studies to confirm.
The timing of this development aligns with concerning epidemiological trends. The increase in poultry and dairy cattle infections, alongside growing human exposures including a U.S. fatality, underscores the zoonotic transmission risk of H5N1. While current human-to-human transmission remains , the expanding animal reservoir increases opportunities for viral mutations that could enhance transmissibility.
The involvement of former CDC Director Dr. Robert Redfield adds credibility to both the scientific approach and the public health framing. Their pursuit of the FDA's Animal Rule pathway is scientifically sound given the challenges of conducting controlled efficacy trials for emerging pathogens. If successful, this approach could establish a template for rapid antiviral development against future pandemic threats.
NEWTOWN, Pa., March 03, 2025 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ: TRAW) (“Traws Pharma”, “Traws” or “the Company”), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of respiratory viral diseases, today announced positive topline results from ferrets infected with H5N1 bird flu, an accepted animal model for human influenza, when treated with tivoxavir marboxil as a single dose. These data are consistent with results reported in December 2024 in a murine model. The new studies reported today evaluated the efficacy of a single dose of tivoxavir marboxil as a treatment for bird flu isolated from a Texas dairy worker and showed suppression of disease, with reduced viral burden in lungs.
“Topline data from the ferret model testing show that tivoxavir marboxil has the potential to inhibit disease after bird flu infection,” said C. David Pauza, PhD, Chief Science Officer for Traws Pharma. “The ferret challenge study builds on the robust protection from bird flu that we observed in a murine model and broadens our understanding of the disease process and the likely range of human doses that will be needed for treatment. We are conducting a similar challenge study in non-human primates, with data expected in Q1 2025.”
“We are witnessing a steady increase in the spread of bird flu,” said Robert R. Redfield, MD, Chief Medical Officer for Traws Pharma and former Director of the U.S. Centers for Disease Control and Prevention (CDC). “Dramatic increases in the number of infected poultry and dairy cattle, with increasing numbers of human exposures including one fatal case in the USA, confirm the ongoing threat of bird flu and the increasing risk for wider spread in the human population. We believe safe and effective antiviral drugs will be a critical component in the response to bird flu and that the development and testing of tivoxavir marboxil could be an important step to achieving that goal. The spread of bird flu in animals and increasing numbers of human exposures underscore the pressing need for effective medical countermeasures.”
“With the non-human primate data in hand, we intend to approach the FDA to discuss an accelerated approval under to the “Animal Rule1,” said Werner Cautreels, Chief Executive Officer of Traws Pharma. “We plan to host a Virtual Investor Update on March 31, 2025 to provide a detailed review of the bird flu program.”
Topline Preclinical Results in Ferrets
Substantial changes in disease progression were observed after a single oral dose of tivoxavir marboxil in the ferret model of bird flu using the A/Texas/37/2024 H5N1 virus isolated from an infected dairy worker in Texas. A lethal challenge in ferrets showed that tivoxavir marboxil increased the proportion of surviving animals and lowered the viral burden in lungs and nasal tissues. Ferrets are an accepted animal model for evaluating treatments for influenza.
Source:
- CFR314.600 thru 314.650, October 2015, https://www.fda.gov/media/88625/download
About Tivoxavir Marboxil
Tivoxavir marboxil 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 in preclinical studies, including the highly pathogenic avian flu H5N1 (bird flu). Completed and ongoing animal model studies are assessing the impact of a single oral dose of tivoxavir marboxil on bird flu infection. We believe that these data support further development of tivoxavir marboxil as a one-time treatment for bird flu. Bird flu and seasonal influenza are estimated to represent a potential multi-billion dollar antiviral market opportunity, largely driven by global health organizations, practice guidelines and government tenders.
About Traws Pharma, Inc.
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 novel, Phase 1, potentially best-in-class, small molecule drug candidates: tivoxavir marboxil, in development for bird flu and seasonal influenza, 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.
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, regulatory requirements; the final data results of the ferret animal model testing; previously reported results of murine studies; studies underway in non-human primates; potential to report the results of non-human primate studies in Q1 2025; the previously reports results of Phase 1 studies; the Company’s intention to seek FDA guidance on the regulatory path; the extent of the spread and threat of bird flu; the potential effectiveness of the use of tivoxavir marboxil for treatment in humans; and those discussed under the heading “Risk Factors” in Traws’ filings with the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements contained in this release speak only as of its date. Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except to the extent required by law.
Traws Pharma Contact:
Nora Brennan
Traws Pharma, Inc.
nbrennan@trawspharma.com
www.trawspharma.com
Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com
FAQ
What were the key results of TRAW's tivoxavir marboxil testing in ferrets for H5N1 bird flu?
When will Traws Pharma (TRAW) release their non-human primate study results for tivoxavir marboxil?
What is TRAW's next regulatory step for tivoxavir marboxil development?
When is Traws Pharma's (TRAW) Virtual Investor Update scheduled for the bird flu program?
