Traws Pharma Advances Antiviral Pipeline with Multiple Regulatory Submissions
Traws Pharma (NASDAQ: TRAW) has announced multiple regulatory submissions advancing its antiviral pipeline. The company has submitted a Phase 2 protocol to HREC for tivoxavir marboxil (TXM) to evaluate its effectiveness against both seasonal and bird flu in the Southern Hemisphere. Additionally, briefing documents were submitted to the FDA for a Type D meeting regarding potential accelerated approval of TXM for bird flu treatment.
The company has also submitted a Phase 2 study protocol to HREC for ratutrelvir, their protease inhibitor that doesn't require ritonavir co-administration, to evaluate its effectiveness against COVID-19. This study will compare ratutrelvir to PAXLOVID® in newly diagnosed patients, with specific focus on disease rebound and Long COVID development. The study includes a separate arm for patients ineligible for PAXLOVID® treatment.
The TXM study will be conducted in Australia and Southeast Asian countries with high rates of human bird flu infections, while the ratutrelvir study will evaluate patients on a 10-day treatment regimen compared to PAXLOVID's® 5-day regimen.
Traws Pharma (NASDAQ: TRAW) ha annunciato diverse sottomissioni regolatorie per far avanzare il suo portafoglio antivirale. L'azienda ha presentato un protocollo di Fase 2 all'HREC per tivoxavir marboxil (TXM) al fine di valutarne l'efficacia contro l'influenza stagionale e aviaria nell'emisfero sud. Inoltre, sono stati inviati documenti informativi alla FDA per una riunione di Tipo D riguardante una possibile approvazione accelerata di TXM per il trattamento dell'influenza aviaria.
La società ha anche sottoposto un protocollo di studio di Fase 2 all'HREC per ratutrelvir, il loro inibitore della proteasi che non richiede la co-somministrazione di ritonavir, per valutarne l'efficacia contro il COVID-19. Questo studio confronterà ratutrelvir con PAXLOVID® in pazienti di nuova diagnosi, con particolare attenzione al rimbalzo della malattia e allo sviluppo del Long COVID. Lo studio prevede un braccio separato per pazienti non idonei al trattamento con PAXLOVID®.
Lo studio su TXM sarà condotto in Australia e in paesi del Sud-est asiatico con alti tassi di infezioni umane da influenza aviaria, mentre lo studio su ratutrelvir valuterà i pazienti con un trattamento di 10 giorni rispetto al regime di 5 giorni di PAXLOVID®.
Traws Pharma (NASDAQ: TRAW) ha anunciado múltiples presentaciones regulatorias para avanzar en su cartera antiviral. La compañía ha enviado un protocolo de Fase 2 al HREC para tivoxavir marboxil (TXM) para evaluar su eficacia contra la gripe estacional y aviar en el hemisferio sur. Además, se presentaron documentos informativos a la FDA para una reunión Tipo D sobre la posible aprobación acelerada de TXM para el tratamiento de la gripe aviar.
La empresa también ha presentado un protocolo de estudio de Fase 2 al HREC para ratutrelvir, su inhibidor de proteasa que no requiere coadministración con ritonavir, para evaluar su eficacia contra COVID-19. Este estudio comparará ratutrelvir con PAXLOVID® en pacientes recién diagnosticados, con especial atención al rebote de la enfermedad y al desarrollo de COVID prolongado. El estudio incluye un brazo separado para pacientes no elegibles para el tratamiento con PAXLOVID®.
El estudio de TXM se llevará a cabo en Australia y en países del sudeste asiático con altas tasas de infecciones humanas por gripe aviar, mientras que el estudio de ratutrelvir evaluará a los pacientes con un régimen de tratamiento de 10 días en comparación con el régimen de 5 días de PAXLOVID®.
Traws Pharma (NASDAQ: TRAW)는 항바이러스 파이프라인을 진전시키기 위한 여러 규제 제출을 발표했습니다. 회사는 남반구에서 계절성 및 조류 인플루엔자에 대한 효과를 평가하기 위해 티복사비르 마르복실(TXM)의 2상 프로토콜을 HREC에 제출했습니다. 또한, 조류 인플루엔자 치료를 위한 TXM의 잠재적 가속 승인과 관련하여 FDA에 Type D 미팅을 위한 브리핑 문서를 제출했습니다.
회사는 또한 리토나비르 동시 투여가 필요 없는 프로테아제 억제제인 라투트렐비르의 2상 연구 프로토콜을 HREC에 제출하여 COVID-19에 대한 효과를 평가할 예정입니다. 이 연구는 새로 진단된 환자에서 라투트렐비르와 PAXLOVID®를 비교하며, 질병 재발과 롱코비드 발생에 중점을 둡니다. 연구에는 PAXLOVID® 치료 대상이 아닌 환자를 위한 별도의 그룹도 포함됩니다.
TXM 연구는 호주와 조류 인플루엔자 감염률이 높은 동남아시아 국가에서 진행되며, 라투트렐비르 연구는 PAXLOVID®의 5일 치료와 비교하여 10일 치료 요법을 평가할 예정입니다.
Traws Pharma (NASDAQ : TRAW) a annoncé plusieurs soumissions réglementaires pour faire progresser son pipeline antiviral. La société a soumis un protocole de Phase 2 au HREC pour tivoxavir marboxil (TXM) afin d’évaluer son efficacité contre la grippe saisonnière et aviaire dans l’hémisphère sud. De plus, des documents d’information ont été soumis à la FDA pour une réunion de type D concernant une éventuelle approbation accélérée de TXM pour le traitement de la grippe aviaire.
La société a également soumis un protocole d’étude de Phase 2 au HREC pour ratutrelvir, leur inhibiteur de protéase ne nécessitant pas la co-administration de ritonavir, afin d’évaluer son efficacité contre la COVID-19. Cette étude comparera ratutrelvir à PAXLOVID® chez des patients nouvellement diagnostiqués, en mettant l’accent sur la réapparition de la maladie et le développement du COVID long. L’étude comprend un bras distinct pour les patients inéligibles au traitement par PAXLOVID®.
L’étude TXM sera menée en Australie et dans des pays d’Asie du Sud-Est présentant des taux élevés d’infections humaines par la grippe aviaire, tandis que l’étude ratutrelvir évaluera les patients sous un traitement de 10 jours comparé au traitement de 5 jours de PAXLOVID®.
Traws Pharma (NASDAQ: TRAW) hat mehrere regulatorische Einreichungen angekündigt, um seine antivirale Pipeline voranzutreiben. Das Unternehmen hat ein Phase-2-Protokoll für tivoxavir marboxil (TXM) bei der HREC eingereicht, um die Wirksamkeit gegen saisonale und Vogelgrippe auf der Südhalbkugel zu evaluieren. Zusätzlich wurden der FDA Unterlagen für ein Type-D-Meeting bezüglich einer möglichen beschleunigten Zulassung von TXM zur Behandlung der Vogelgrippe vorgelegt.
Das Unternehmen hat außerdem ein Phase-2-Studienprotokoll für ratutrelvir, ihren Proteaseinhibitor, der keine Ritonavir-Ko-Medikation benötigt, bei der HREC eingereicht, um dessen Wirksamkeit gegen COVID-19 zu prüfen. Diese Studie wird ratutrelvir mit PAXLOVID® bei neu diagnostizierten Patienten vergleichen, mit besonderem Fokus auf Krankheitsrückfälle und die Entwicklung von Long COVID. Die Studie umfasst eine separate Gruppe für Patienten, die für eine PAXLOVID®-Behandlung nicht infrage kommen.
Die TXM-Studie wird in Australien und Ländern Südostasiens mit hohen Raten von menschlichen Vogelgrippe-Infektionen durchgeführt, während die ratutrelvir-Studie Patienten mit einem 10-tägigen Behandlungsregime im Vergleich zum 5-tägigen Regime von PAXLOVID® untersucht.
- Development of TXM as potential best-in-class CAP-dependent endonuclease inhibitor for both seasonal and bird flu
- Ratutrelvir's potential advantage of not requiring ritonavir co-administration unlike current treatments
- Expanded study scope to address unmet needs including PAXLOVID-ineligible patients and Long COVID
- Strategic study locations in regions with high rates of bird flu transmission
- Both drug candidates still in Phase 2 testing phase, indicating significant time before potential commercialization
- Regulatory approval pathway for bird flu indication still uncertain, requiring further FDA discussions
Insights
Traws Pharma advances two antivirals through regulatory processes for influenza and COVID-19, strengthening its development pipeline with potential market differentiation.
Traws Pharma has made significant progress with its antiviral portfolio through multiple regulatory submissions for two key drug candidates. For tivoxavir marboxil (TXM), the company submitted a Phase 2 protocol to HREC for a dual-purpose study evaluating both seasonal influenza and the more concerning H5N1 bird flu, primarily targeting Australia and Southeast Asia where bird flu transmission is higher. This strategic approach could position TXM as a broad-spectrum influenza treatment.
Additionally, Traws submitted briefing materials to the FDA for a Type D meeting to discuss potential accelerated approval pathways for TXM in bird flu treatment, including possible application of the Animal Rule - a regulatory pathway that allows approval based on animal efficacy studies when human trials aren't ethical or feasible.
For their second candidate, ratutrelvir, Traws submitted a Phase 2 protocol to evaluate it against PAXLOVID
What's most significant is the strategic positioning of both compounds as potentially "best in class" - TXM as a CAP-dependent endonuclease inhibitor for influenza and ratutrelvir as a protease inhibitor that doesn't require ritonavir co-administration for COVID-19. Both aim to overcome limitations of existing approved treatments, potentially giving Traws competitive advantages if successful in clinical development.
Phase 2 protocol submitted to HREC to evaluate tivoxavir marboxil (TXM) in a combined seasonal and bird flu study in the Southern Hemisphere
Briefing documents submitted to FDA for a Type D meeting request to continue discussions on path forward for accelerated approval of TXM for bird flu
Phase 2 study protocol submitted to HREC to evaluate ratutrelvir in newly diagnosed COVID patients, with extensions to measure disease rebound and development of Long COVID
NEWTOWN, Pa., June 30, 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 multiple regulatory submissions related to its antiviral pipeline.
Tivoxavir marboxil
A proposed Phase 2 dose-ranging, non-inferiority study will evaluate the effects of tivoxavir marboxil (TXM), a potential best in class CAP-dependent endonuclease inhibitor, compared to XOFLUZA®, in patients infected with seasonal influenza. A separate single arm will evaluate the effects of TXM in patients infected with H5N1 bird flu. The proposed study has been submitted for Human Research Ethics Committee (HREC) review and is expected to enroll subjects in Australia and selected countries in Southeast Asia (SE Asia) with high rates of human bird flu infections.
“This combined study, evaluating the effects of TXM in seasonal and bird flu patients, could support the broad use of TXM against multiple influenza strains,” commented Robert R. Redfield, MD, Chief Medical Officer for Traws Pharma and former Director of the U.S. Centers for Disease Control and Prevention (CDC). “The high rates of animal-to-human transmission of bird flu in SE Asia should allow us to evaluate the efficacy of TXM in this important clinical setting, adding to our robust pre-clinical efficacy results of TXM against bird flu.”
Also, as a follow up to recent Pre-IND FDA interactions on TXM, Traws submitted briefing materials for a Type D meeting to enable further FDA dialog on a potential path to accelerated approval for bird flu.
“We are continuing to discuss with the FDA the applicability of the Animal Rule and other routes that could support an accelerated approval of TXM for bird flu,” commented C. David Pauza, PhD, Chief Science Officer for Traws Pharma. “We look forward to continuing positive interactions with the Agency.”
Ratutrelvir
A proposed Phase 2 non-inferiority study will evaluate the effects of ratutrelvir, a potential best in class protease inhibitor that does not require ritonavir co-administration, compared to PAXLOVID®, in newly diagnosed COVID patients. The proposed study that has been submitted for HREC review is intended to enroll patients on a 10-day treatment regimen for ratutrelvir compared to the approved 5-day regimen for PAXLOVID®. In addition to efficacy and safety endpoints, the proposed study will also evaluate the rates of disease rebound as well as the incidence of Long COVID.
A separate single arm will evaluate the safety and efficacy of ratutrelvir in newly diagnosed COVID patients who are ineligible for treatment with PAXLOVID®.
“A significant population of patients who are at risk for poor outcomes from COVID are ineligible for PAXLOVID®. In addition, rebound infections and prevention of the development of Long COVID are unaddressed by existing therapies. We believe ratutrelvir has the potential to overcome these issues,” commented Dr. Redfield. “Our proposed Phase 2 study is expected to highlight the differentiating attributes of ratutrelvir compared to existing approved therapies.”
“Today’s announcements demonstrate our commitment to rapidly advance our antiviral portfolio,” commented Iain D. Dukes, MA, DPhil, Interim Chief Executive Officer for Traws Pharma. “We look forward to delivering these potentially vital medicines to patients.”
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. It has potent in vitro activity against a range of influenza strains in preclinical studies, including a human isolate of the highly pathogenic avian flu H5N1 (bird flu). Consistent, positive preclinical data from three animal species indicate that a single dose of TXM demonstrated a therapeutic effect against H5N1 bird flu. Seasonal influenza represents an estimated multi-billion dollar antiviral market opportunity, largely driven by global health organizations, practice guidelines and government tenders1,2, with upside potential from potential pandemic flu outbreaks including H5N1 bird flu. We believe that these data support further development of TXM as a treatment for bird flu.
About Ratutrelvir
Ratutrelvir is an investigational oral, small molecule Mpro (3CL protease) inhibitor designed to be a broadly acting treatment for COVID-19 that is used without ritonavir. It has demonstrated in vitro activity against a range of COVID-19 strains. Preclinical and Phase 1 studies show that ratutrelvir does not require co-administration with a metabolic inhibitor, such as ritonavir, which could avoid ritonavir-associated drug-drug interactions3, and potentially enable wider patient use. Phase 1 data also show that ratutrelvir’s pharmacokinetic (PK) profile demonstrated maintenance of target blood plasma levels approximately 13 times above the EC50 using the target Phase 2 dosing regimen of 600 mg/day for ten days, which may also reduce the likelihood of clinical rebound and, consequently, reduce the risk for Long COVID4. Industry data indicate that COVID treatment represents a potential multi-billion dollar market opportunity5,6.
Source information:
- Per link
- TRAW data on file
- https://ascpt.onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2646
- Carly Herbert et al. (2025) Clinical Infectious Diseases. https://doi.org/10.1093/cid/ciae539
- Pfizer.com 10K report 2024, Feb 27, 2025
- Merck & Co 10K, Feb 25, 2025
Third-party products mentioned herein are the trademarks of their respective owners.
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. Traws integrates antiviral drug development, medical intelligence and regulatory strategy to meet real world challenges in the treatment of viral diseases. We are advancing novel investigational oral small molecule antiviral agents that have potent activity against difficult to treat or resistant virus strains that threaten human health: bird flu and seasonal influenza, and COVID-19/Long COVID. 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 ritonavir-independent COVID treatment, targeting the Main protease (Mpro or 3CL protease).
Traws is actively seeking development and commercialization partners for its legacy clinical oncology programs, rigosertib and narazaciclib. More details can be found on Traws’ website at https://www.ir.trawspharma.com/partnering.
For more information, please visit www.trawspharma.com and follow us on LinkedIn.
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 our ability to proceed with our proposed clinical trials and to enroll sufficient subjects in such studies and trials, the success and timing of Traws’ clinical trials, our ability to take advantage of expedited regulatory pathways for tivoxavir marboxil, our ability to obtain regulatory approval of tivoxavir marboxil and ratutrelvir, the expectations of our interactions with regulatory authorities, including the FDA, the Human Research Ethics Committee (HREC) and other international regulatory agencies, market conditions, regulatory requirements, changes in government regulation, the extent of the spread and threat of bird flu, seasonal influenza and COVID, 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:
John Fraunces
LifeSci Advisors, LLC
917-355-2395
jfraunces@lifesciadvisors.com
FAQ
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