Traws Pharma Doses First Patient with Ratutrelvir in Phase 2 COVID Studies, Expects Results by Year-End 2025
Traws Pharma (NASDAQ: TRAW) announced dosing of the first subject in two Phase 2 studies of ratutrelvir, a ritonavir‑free oral antiviral for newly diagnosed COVID-19 patients on Oct 14, 2025.
One trial is a non-inferiority study versus PAXLOVID® assessing safety, disease rebound and incidence of Long COVID; a second is a single-arm study in PAXLOVID®‑ineligible patients. The company expects top-line data from both trials by year-end 2025. Management highlights once-daily, single‑tablet 10‑day dosing and aims to evaluate tolerability and rates of COVID symptoms and rebound.
Traws Pharma (NASDAQ: TRAW) ha annunciato il dosaggio del primo soggetto in due studi di fase 2 su ratutrelvir, un antivirale orale privo di ritonavir per i pazienti con COVID-19 recentemente diagnosticati, il 14 ottobre 2025.
Uno studio è uno studio di non inferiorità rispetto a PAXLOVID® che valuta sicurezza, rimbalzo della malattia e incidenza di Long COVID; un secondo è uno studio single-arm in pazienti non idonei a PAXLOVID®. L'azienda prevede dati di rilascio principali di entrambi gli studi entro la fine del 2025. La gestione sottolinea una somministrazione una volta al giorno, una singola compressa per 10 giorni e mira a valutare la tollerabilità e i tassi di sintomi e rimbalzo del COVID.
Traws Pharma (NASDAQ: TRAW) anunció la administración del primer sujeto en dos ensayos de fase 2 de ratutrelvir, un antiviral oral sin ritonavir para pacientes con COVID-19 recién diagnosticados, el 14 de octubre de 2025.
Un ensayo es un estudio de no inferioridad frente a PAXLOVID® evaluando seguridad, rebote de la enfermedad e incidencia de Long COVID; un segundo es un ensayo single-arm en pacientes no elegibles para PAXLOVID®. La compañía espera ver datos principales de ambos ensayos para finales de 2025. La dirección destaca la dosis de una tableta al día durante 10 días y tiene como objetivo evaluar la tolerabilidad y las tasas de síntomas y rebote de COVID.
Traws Pharma (NASDAQ: TRAW)은 PAXLOVID® 없이 경구 항바이러스제인 ratutrelvir의 두 개의 2상 연구에서 첫 피험자에 대한 투여를 2025년 10월 14일 발표했다.
하나는 PAXLOVID®와의 비 열등성 연구로 안전성, 질병 재발 및 Long COVID의 발생을 평가하고; 다른 하나는 PAXLOVID®에 적합하지 않은 환자들을 대상으로 한 단일군 연구이다. 회사는 두 연구의 주요 데이터를 2025년 말까지 기대하고 있다. 경영진은 하루에 한 번, 한 알로 10일 간 복용하는 투약을 강조하며 내약성 및 COVID 증상과 재발 비율을 평가하는 것을 목표로 한다.
Traws Pharma (NASDAQ: TRAW) a annoncé l'administration du premier sujet dans deux essais de phase 2 de ratutrelvir, un antiviral oral sans ritonavir pour les patients récemment diagnostiqués COVID-19, le 14 octobre 2025.
L'un des essais est une étude de non‑infériorité par rapport à PAXLOVID® évaluant la sécurité, le rebond de la maladie et l'incidence du Long COVID ; le second est une étude à bras unique chez des patients éligibles ou non à PAXLOVID® ? Le texte précise “non éligibles” pour les patients. L'entreprise s'attend à des données préliminaires des deux essais d'ici fin 2025. La direction met en avant une posologie une fois par jour, une seule comprimé pendant 10 jours et vise à évaluer la tolérance ainsi que les taux de symptômes et de rebond du COVID.
Traws Pharma (NASDAQ: TRAW) kündigte die Dosierung des ersten Probanden in zwei Phase-2-Studien zu Ratutilvir an, einem ritonavirfreien oralen antiviralen Mittel für neu diagnostizierte COVID-19-Patienten, am 14. Oktober 2025.
Eine Studie ist eine Neben‑Infierioritätsstudie gegen PAXLOVID® und bewertet Sicherheit, Krankheitsrückfall und Long-COVID-Inzidenz; eine zweite ist eine Single-Arm-Studie bei PAXLOVID®-nicht berechtigten Patienten. Das Unternehmen erwartet Top-Line-Daten von beiden Studien bis Ende 2025. Das Management hebt eine einmal tägliche, einzelne Tablette über 10 Tage hervor und zielt darauf ab, Verträglichkeit sowie Raten von COVID-Symptomen und Rückfällen zu bewerten.
Traws Pharma (NASDAQ: TRAW) أعلنت إعطاء الجرعة لأول متطوع في دراستين من المرحلة الثانية لـ ratutrelvir، وهو مضاد فيروسات فموي خالٍ من Ritonavir لمرضى COVID-19 الذين تم تشخيصهم حديثاً، في 14 أكتوبر 2025.
إحدى الدراسات هي دراسة عدم التفوق مقارنة بـ PAXLOVID® وتقيّم السلامة وحدوث ارتداد المرض ومعدّلات Long COVID؛ أما الدراسة الثانية فـ بذراع واحد في مرضى غير مؤهلين لـ PAXLOVID®، وتتوقع الشركة بيانات رئيسية من كلا الدراستين بحلول نهاية 2025. وتبرز الإدارة جرعة يومية واحدة، قرص واحد لمدة 10 أيام وتهدف إلى تقييم التحمل ومعدلات أعراض COVID والارتداد.
Traws Pharma (NASDAQ: TRAW) 于 2025年10月14日宣布在两项II期研究中对 ratutrelvir 开始给药，这是一种无 ritonavir 的口服抗病毒药物，适用于新诊断的 COVID-19 患者。
一项研究是对比 PAXLOVID® 的 非劣效性 研究，评估安全性、疾病反跳和 Long COVID 的发生率；另一项是在研究 单臂 的研究，针对不符合 PAXLOVID® 适用条件的患者。公司预计两项研究的主要数据将于 2025 年底 公布。管理层强调每日一次、单片剂用药 10 天，并旨在评估耐受性以及 COVID 症状和反跳的发生率。
- Phase 2 dosing initiated on Oct 14, 2025
- Non-inferiority trial versus PAXLOVID® includes rebound and Long COVID endpoints
- Separate trial targets PAXLOVID®-ineligible vulnerable population
- Planned top-line data by year-end 2025
- Phase 2 status — efficacy not yet proven
- Non-inferiority design may not show superiority versus PAXLOVID®
- Top-line timing is an expectation, not a guaranteed outcome
Insights
Phase 2 first‑patient dosing advances the program; topline readouts expected by
The trial tests ratutrelvir versus PAXLOVID® in a non‑inferiority design and runs a separate single‑arm study in PAXLOVID®‑ineligible subjects, so the design directly compares safety, rebound rates and Long COVID incidence.
Key dependencies include enrollment speed, event rates for rebound and Long COVID, and preservations of trial integrity in a changing viral landscape; these will determine interpretability of non‑inferiority margins. Watch for primary endpoint definitions and the timing of interim analyses by
First dosing is a clinical milestone with potential commercial implications if Phase 2 data are positive by
Ratutrelvir is positioned as a once‑daily, ritonavir‑free oral therapy targeting rebound and Long COVID, and a single‑tablet 10‑day regimen could simplify use for vulnerable populations and those ineligible for PAXLOVID®.
Risks include uncertain Phase 2 effect sizes and whether safety or efficacy will convincingly meet non‑inferiority criteria; monitor enrollment completion, endpoint adjudication details, and the topline release timing expected by
Non-inferiority trial versus PAXLOVID® assessing safety and efficacy, including rates of disease rebound and incidence of Long COVID development, of ratutrelvir, a ritonavir-free anti-viral treatment
Separate single-arm trial assessing safety and efficacy in PAXLOVID®-ineligible subjects, who represent a significant, vulnerable population with few available treatment options
Top-line data from both trials expected by year-end 2025
NEWTOWN, Pa., Oct. 14, 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 the dosing of the first subject in a Phase 2 study to evaluate ratutrelvir, a ritonavir-free anti-viral treatment in newly diagnosed COVID subjects.
“The first trial will enable Traws to compare ratutrelvir, a potential best in class ritonavir-free agent, against the current gold standard, PAXLOVID®,” said Iain D. Dukes, MA, DPhil, Chief Executive Officer of Traws Pharma. “This study will evaluate safety, as well as rates of infection, COVID symptoms, disease rebound and incidence of Long COVID. In addition, we will initiate a second trial to evaluate the safety and efficacy of ratutrelvir in PAXLOVID®-ineligible patients, a population at risk for poor outcomes from COVID infection with few available treatment options. Our expectation is to be able to report the results of both Phase 2 studies by year-end 2025.”
“Across the US, we see multiple signs that COVID continues to threaten public health, especially among elderly and vulnerable individuals,” said Robert R. Redfield, MD, Chief Medical Officer of Traws Pharma. “We believe that Traws’ ritonavir-free COVID therapeutic candidate, ratutrelvir, has the potential to overcome the shortcomings of current treatments and become the new standard of care. Ratutrelvir’s good overall tolerability allows once-daily, single tablet dosing for 10 days, which could reduce the rate of rebound and the risk of Long COVID. Positive results could provide important proof-of-concept data and represent a valuable inflection point for the program.”
About Ratutrelvir
Ratutrelvir is an investigational oral, small molecule Mpro (3CL protease) inhibitor designed to be a broadly acting treatment for SARS-CoV-2/COVID-19 that is used without ritonavir. It has demonstrated in vitro activity against a range of virus 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 interactions1, and potentially enable wider patient use. Phase 1 data also showed 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 reduce the likelihood of clinical rebound and, consequently, reduce the risk for Long COVID2. Industry data indicate that COVID treatment represents a potential multi-billion dollar market opportunity3.
Source information:
- 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 Inc. 10K report 2024, Feb 27, 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: COVID-19/Long COVID and bird flu and seasonal influenza. Ratutrelvir is in development as a ritonavir-independent COVID treatment, targeting the Main protease (Mpro or 3CL protease). Tivoxavir marboxil is in development as a single dose treatment for bird flu and seasonal influenza, targeting the influenza cap-dependent endonuclease (CEN).
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, market size, benefits, effectiveness, safety, and the clinical and regulatory plans for ratutrelvir and tivoxavir marboxil, as well as plans for its legacy programs. The Company has attempted to identify forward-looking statements by terminology including “believes”, “estimates”, “anticipates”, “expects”, “plans”, “intends”, “may”, “could”, “might”, “will”, “should”, “potential”, “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, including when Traws will report results of the Phase 2 studies of ratutrelvir; the potential efficacy of ratutrelvir for the treatment of COVID-19; the potential for ratutrelvir to gain market acceptance, if and when regulatory approval is obtained, or become the new standard of care; Traws’ interactions with the FDA, BARDA and similar foreign regulators; collaborations; market conditions; regulatory requirements and pathways for approval; the ongoing need for improved therapy to reduce the frequency of clinical rebound and the concomitant risk for Long COVID; the extent of the spread and threat of the bird flu; Traws’ ability to raise additional capital when needed; 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:
Charles Parker
Traws Pharma, Inc.
cparker@trawspharma.com
www.trawspharma.com
Investor Contact:
John Fraunces
LifeSci Advisors, LLC
917-335-2395
jfraunces@lifesciadvisors.com
FAQ
What trials did Traws Pharma (TRAW) start for ratutrelvir on Oct 14, 2025?
When does Traws expect top-line Phase 2 results for ratutrelvir (TRAW)?
What endpoints will the ratutrelvir non-inferiority trial (TRAW) assess?
Why is the single-arm Phase 2 study for ratutrelvir important for PAXLOVID®-ineligible patients?
What is the proposed dosing regimen for ratutrelvir in the Phase 2 studies?
