Traws Pharma’s Bird Flu Drug Candidate, Tivoxavir Marboxil, Presented at ICAR
Traws Pharma (NASDAQ: TRAW) presented positive data for its bird flu drug candidate Tivoxavir Marboxil (TXM) at ICAR 2025 in Las Vegas. The data showcased TXM's potential as an effective bird flu treatment, demonstrating:
- 100% survival rate in rodent challenge models with significant reductions in lung viremia
- Potent suppression of influenza A, B, and C viruses, including baloxavir resistant strains
- Sub-nanomolar potency against H5N1/influenza A virus
- Phase 1 results showing single-dose maintenance of plasma levels at EC90 for ~3 weeks with good tolerability
The company plans to meet with the FDA to discuss potential accelerated approval pathways. A full dataset will be presented during an Investor Call on March 31, 2025.
Traws Pharma (NASDAQ: TRAW) ha presentato dati positivi per il suo candidato farmaco contro l'influenza aviaria Tivoxavir Marboxil (TXM) all'ICAR 2025 a Las Vegas. I dati hanno messo in evidenza il potenziale di TXM come trattamento efficace per l'influenza aviaria, dimostrando:
- Un tasso di sopravvivenza del 100% nei modelli di sfida su roditori con significative riduzioni della viremia polmonare
- Potente soppressione dei virus influenzali A, B e C, comprese le varianti resistenti al baloxavir
- Potenza sub-nanomolare contro il virus H5N1/influenza A
- Risultati della fase 1 che mostrano il mantenimento dei livelli plasmatici a EC90 con una singola dose per circa 3 settimane e buona tollerabilità
L'azienda prevede di incontrare la FDA per discutere potenziali percorsi di approvazione accelerata. Un dataset completo sarà presentato durante una chiamata con gli investitori il 31 marzo 2025.
Traws Pharma (NASDAQ: TRAW) presentó datos positivos para su candidato a fármaco contra la gripe aviar Tivoxavir Marboxil (TXM) en el ICAR 2025 en Las Vegas. Los datos destacaron el potencial de TXM como un tratamiento efectivo para la gripe aviar, demostrando:
- Tasa de supervivencia del 100% en modelos de desafío con roedores con reducciones significativas en la viremia pulmonar
- Supresión potente de los virus de la influenza A, B y C, incluidas las cepas resistentes al baloxavir
- Potencia sub-nanomolar contra el virus H5N1/influenza A
- Resultados de la fase 1 que muestran el mantenimiento de niveles plasmáticos a EC90 durante aproximadamente 3 semanas con buena tolerancia
La empresa planea reunirse con la FDA para discutir posibles vías de aprobación acelerada. Un conjunto de datos completo se presentará durante una llamada con inversores el 31 de marzo de 2025.
트로스 파마(Traws Pharma) (NASDAQ: TRAW)는 라스베가스에서 열린 ICAR 2025에서 조류 인플루엔자 치료제 후보 티복사비르 마르복실(Tivoxavir Marboxil, TXM)에 대한 긍정적인 데이터를 발표했습니다. 이 데이터는 TXM의 조류 인플루엔자 치료제로서의 가능성을 보여주었습니다:
- 설치류 도전 모델에서 100% 생존율과 폐 바이러스 수치의 유의미한 감소
- 발록사비르 내성 균주를 포함한 인플루엔자 A, B 및 C 바이러스에 대한 강력한 억제
- H5N1/인플루엔자 A 바이러스에 대한 서브 나노몰 농도의 효능
- 단일 용량으로 약 3주 동안 EC90의 혈장 수준 유지와 좋은 내약성에 대한 1상 결과
회사는 FDA와 만나 잠재적인 신속 승인 경로에 대해 논의할 계획입니다. 전체 데이터 세트는 2025년 3월 31일 투자자 통화 중에 발표될 예정입니다.
Traws Pharma (NASDAQ: TRAW) a présenté des données positives pour son candidat médicament contre la grippe aviaire Tivoxavir Marboxil (TXM) lors de l'ICAR 2025 à Las Vegas. Les données ont mis en évidence le potentiel de TXM en tant que traitement efficace contre la grippe aviaire, démontrant :
- Un taux de survie de 100 % dans des modèles de défi chez les rongeurs avec des réductions significatives de la viremie pulmonaire
- Une suppression puissante des virus de la grippe A, B et C, y compris les souches résistantes au baloxavir
- Une puissance sub-nanomolaire contre le virus H5N1/grippe A
- Des résultats de phase 1 montrant le maintien des niveaux plasmatiques à EC90 pendant environ 3 semaines avec une bonne tolérance
L'entreprise prévoit de rencontrer la FDA pour discuter des voies d'approbation accélérée potentielles. Un ensemble de données complet sera présenté lors d'un appel aux investisseurs le 31 mars 2025.
Traws Pharma (NASDAQ: TRAW) hat auf dem ICAR 2025 in Las Vegas positive Daten für seinen Medikamentenkandidaten gegen Vogelgrippe Tivoxavir Marboxil (TXM) präsentiert. Die Daten zeigten das Potenzial von TXM als effektive Behandlung gegen Vogelgrippe und demonstrierten:
- Eine Überlebensrate von 100% in Herausforderungen mit Nagetieren mit signifikanten Reduktionen der Lungenviremie
- Starke Unterdrückung der Influenza-Viren A, B und C, einschließlich baloxavir-resistenter Stämme
- Sub-nanomolare Potenz gegen das H5N1/Influenza-A-Virus
- Ergebnisse der Phase 1, die eine Aufrechterhaltung der Plasmaspiegel bei EC90 für ca. 3 Wochen mit guter Verträglichkeit zeigen
Das Unternehmen plant, sich mit der FDA zu treffen, um potenzielle beschleunigte Genehmigungswege zu besprechen. Ein vollständiger Datensatz wird während eines Investorenanrufs am 31. März 2025 präsentiert.
- 100% survival rate in rodent challenge models vs. 0% in untreated group
- Demonstrated efficacy against multiple flu strains including resistant variants
- Single dose maintains therapeutic levels for ~3 weeks
- Good tolerability profile in Phase 1 trials
- Still requires FDA approval and further clinical trials
- Early-stage development (only Phase 1 completed)
Insights
The preclinical and Phase 1 data for Tivoxavir Marboxil present a compelling case for its potential in addressing H5N1 (bird flu) infections. The 100% survival rate in the rodent challenge model with no virus-induced weight loss demonstrates robust efficacy in a relevant animal model. This is particularly significant when compared to the complete mortality in the control group by day 6.
The drug's sub-nanomolar potency against H5N1 influenza A virus indicates exceptional antiviral activity. Even more impressive is TXM's demonstrated efficacy against baloxavir-resistant influenza strains, addressing a critical concern in antiviral resistance management.
From a clinical perspective, the Phase 1 pharmacokinetic profile showing three-week maintenance of effective plasma levels from a single dose represents a substantial advantage over current influenza antivirals that typically require multiple doses. This prolonged activity could translate to improved patient compliance and effectiveness in real-world settings.
While rodent models don't always translate perfectly to human outcomes, the consistency between these results and previously reported ferret data strengthens confidence in TXM's translational potential. The planned FDA discussions regarding accelerated approval pathways reflect an appropriate strategy for addressing this emerging public health threat, though regulatory requirements will need careful navigation.
Traws Pharma's TXM program represents strategic positioning in the high-value pandemic preparedness market. The positive data presented at ICAR could create significant value through multiple pathways:
- The bird flu focus provides potential for expedited regulatory review, as mentioned in their plans to discuss accelerated approval with the FDA
- The single-dose treatment maintaining effective blood levels for ~3 weeks offers substantial competitive advantages over multi-dose regimens, particularly in pandemic scenarios
- Activity against resistant viruses addresses a critical limitation of existing antivirals
- The program's expansion potential beyond bird flu to seasonal influenza could substantially expand the addressable market
The increased exposure risk among agricultural workers highlighted in the announcement suggests a potential initial market focus. Government contracts for stockpiling in pandemic preparedness could provide early revenue opportunities before broader commercialization.
For TRAW, with a market cap of
The upcoming March 31 investor call will likely provide critical insights into development timelines and regulatory strategy that could further clarify TXM's commercial potential and path to market.
- Poster underscores Tivoxavir Marboxil’s potential for the treatment of bird flu, supported by
100% survival in a rodent challenge model, potent suppression of resistant viruses and Phase 1 data - Full dataset to be highlighted during Investor Call on March 31, 2025 at 10:00 AM ET
NEWTOWN, Pa., March 21, 2025 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ: TRAW) (“Traws Pharma”, “Traws” or “the Company”), a clinical-stage biopharmaceutical company developing novel therapies to target critical threats to human health from respiratory viral diseases, today announced that positive data supporting the potential for tivoxavir marboxil (TXM) as a bird flu treatment was presented yesterday in a poster at the International Society for Antiviral Research (ICAR 2025), being held in Las Vegas, Nevada.
C. David Pauza, PhD, Chief Science Officer of Traws Pharma commented, “Bird flu has emerged as a potential threat to human health. Extensive spread in poultry and dairy farms have increased the exposure risk for agricultural workers. We believe an effective antiviral agent for bird flu needs to potently suppress native and resistant viruses and provide protection against mortality and viral disease, with good overall tolerability and ease of use. The positive data presented at ICAR, from laboratory, preclinical and Phase 1 studies, reinforce our view that TXM meets that target profile and has the potential to be a potent, effective and safe treatment for bird flu, with broad applicability to seasonal flu. Looking ahead, we plan to meet with the FDA to align on next steps, including the potential for an accelerated path to approval.”
“We were pleased to have the opportunity to share the promising TXM results in bird flu with the international antiviral community during the poster session at ICAR. We look forward to updating investors on Traws’ antiviral programs during a virtual event on Monday, March 31, 2025 at 10:00 AM ET, said Werner Cautreels, PhD, Chief Executive Officer of Traws Pharma.
Tivoxavir Marboxil Poster
| Poster Title: | Tivoxavir marboxil, an Influenza Inhibitor Targeting Cap-dependent Endonuclease: Results from a Phase I Trial Demonstrating Safety, Tolerability and Pharmacokinetics and Demonstrating Protection Against H5N1 Bird Flu in a Rodent Challenge Model |
| Poster Date: | March 20, 2025 |
Data in the poster support potential use of single dose treatment of TXM in bird flu:
- Potent Preclinical Suppression of Resistant Virus: Laboratory studies showed that TXM potently suppressed influenza A, B and C viruses and baloxavir resistant flu viruses, with sub-nanomolar potency against H5N1/influenza A virus.
- Potent Antiviral Activity in Preclinical Challenge Model: Results from a rodent challenge model showed that
100% of mice treated with TXM survived, with no virus-induced weight loss and significant reductions in lung viremia, whereas all untreated animals succumbed by study day 6. These data are consistent with previously reported ferret data. - Phase 1 data show potential for single treatment to maintain target drug levels: Results in healthy volunteers showed that a single dose of TXM maintained plasma blood levels at EC90 for ~3 weeks, with good overall tolerability. The study incorporated a wide dose range in anticipation that bird flu would be more virulent and hard to treat.
About ICAR
The International Conference on Antiviral Research (ICAR, https://www.isar-icar.com/ICAR2025) is an international organization dedicated to bringing together scientists and clinicians from multiple disciplines to discuss the latest advances and breakthroughs in antiviral research.
About Tivoxavir Marboxil
Tivoxavir marboxil (TXM) is an investigational oral, small molecule CAP-dependent endonuclease inhibitor designed to be administered as a single-dose for the treatment of bird flu and seasonal influenza. Consistent, positive preclinical data from three species indicate that a single-dose of TXM demonstrated a therapeutic effect against H5N1 bird flu. Seasonal influenza represents an estimated multi-billion antiviral market opportunity, largely driven by global health organizations, practice guidelines and government tenders1, with upside potential from potential pandemic flu outbreaks including H5N1 bird flu. We believe that these data support further development of tivoxavir marboxil as a treatment for bird flu.
Source information: 1. TRAW data on file; 2. Mostafa, A., Barre, R.S., Allue-Guardia, A., et al. (2025) Emerging Microbes and Infections, https://doi.org/10.1080/22221751.2024.2447614
About Traws Pharma, Inc.
Traws Pharma is a clinical stage biopharmaceutical company dedicated to developing novel therapies to target critical threats to human health in respiratory viral diseases. We strive to advance novel investigational antiviral agents that have potent activity against difficult to treat or resistant virus strains that threaten human health. Our product candidates are intended to be safe, with simple dosing regimen. We seek to utilize accelerated clinical trial strategies with a commitment to patients who are especially vulnerable.
The Company’s two antiviral programs are investigational oral small molecules targeting bird flu and seasonal influenza, and COVID-19. Tivoxavir marboxil is in development as a single dose treatment for bird flu and seasonal influenza, targeting the influenza cap-dependent endonuclease (CEN). Ratutrelvir is in development as a COVID treatment, targeting the Main protease (Mpro or 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, effectiveness, safety, 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 and pathways for approval, the extent of the spread and threat of the bird flu, 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
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