Atea Pharmaceuticals Announces Positive Results from Phase 2 Study of Bemnifosbuvir and Ruzasvir Regimen for Treatment of Hepatitis C Virus (HCV)
Atea Pharmaceuticals (NASDAQ: AVIR) announced positive Phase 2 study results for its HCV treatment combining bemnifosbuvir and ruzasvir. The study met its primary endpoints with a 98% sustained virologic response rate at 12 weeks post-treatment in treatment-adherent patients after an eight-week regimen.
The treatment showed 95% efficacy in the overall evaluable population, including non-adherent patients. The regimen was generally safe with no drug-related serious adverse events. Non-cirrhotic patients achieved a 99% success rate, while cirrhotic patients showed 88% efficacy.
The company plans to initiate a Phase 3 program in early 2025, following an FDA meeting. The upcoming phase will feature a fixed-dose combination tablet, reducing daily pill count from four to two tablets.
Atea Pharmaceuticals (NASDAQ: AVIR) ha annunciato risultati positivi della fase 2 dello studio per il suo trattamento dell'HCV che combina bemnifosbuvir e ruzasvir. Lo studio ha raggiunto gli obiettivi primari con un tasso di risposta virologica sostenuta del 98% a 12 settimane dopo il trattamento nei pazienti che hanno aderito della durata di otto settimane.
Il trattamento ha mostrato una efficacia del 95% nella popolazione valutabile complessiva, inclusi i pazienti non aderenti. Il regime è stato generalmente sicuro, senza eventi avversi gravi correlati al farmaco. I pazienti non cirrotici hanno raggiunto un tasso di successo del 99%, mentre i pazienti cirrotici hanno mostrato un'efficacia dell'88%.
L'azienda prevede di avviare un programma di fase 3 all'inizio del 2025, dopo un incontro con la FDA. La fase successiva presenterà un tablet di combinazione a dose fissa, riducendo il numero di pillole giornaliere da quattro a due.
Atea Pharmaceuticals (NASDAQ: AVIR) anunció resultados positivos del estudio de fase 2 para su tratamiento del HCV que combina bemnifosbuvir y ruzasvir. El estudio alcanzó sus objetivos primarios con una tasa de respuesta virológica sostenida del 98% a las 12 semanas post-tratamiento en pacientes cumplidores tras un régimen de ocho semanas.
El tratamiento mostró 95% de eficacia en la población evaluable total, incluidos los pacientes no cumplidores. El régimen fue generalmente seguro y no se reportaron eventos adversos graves relacionados con el medicamento. Los pacientes no cirróticos lograron una tasa de éxito del 99%, mientras que los pacientes cirróticos mostraron una eficacia del 88%.
La empresa planea iniciar un programa de fase 3 a principios de 2025, tras una reunión con la FDA. La próxima fase contará con un comprimido de combinación a dosis fija, reduciendo la cantidad diaria de píldoras de cuatro a dos.
Atea Pharmaceuticals (NASDAQ: AVIR)는 bemnifosbuvir와 ruzasvir를 결합한 HCV 치료의 2상 연구 결과를 발표했습니다. 이 연구는 8주 요법 후 치료에 잘 따른 환자에서 12주 후에 98%의 지속적인 바이러스 반응율이 나타나며 주요 목표를 달성했습니다.
치료는 비순응 환자를 포함한 전체 평가 가능한 인구에서 95%의 효능을 보였습니다. 이 요법은 일반적으로 안전했으며 약물 관련 중대한 이상 반응이 없었습니다. 비간경변 환자는 99%의 성공률을 달성했으며, 간경변 환자는 88%의 효능을 보였습니다.
회사는 FDA 회의 후 2025년 초에 3상 프로그램을 시작할 예정입니다. 다가오는 단계에서는 하루 복용량을 4개에서 2개의 정제로 줄이는 고정 용량 조합 제제가 특징입니다.
Atea Pharmaceuticals (NASDAQ: AVIR) a annoncé des résultats positifs d'une étude de phase 2 pour son traitement de l'hépatite C combinant bemnifosbuvir et ruzasvir. L'étude a atteint ses objectifs principaux avec un taux de réponse virologique soutenue de 98% 12 semaines après le traitement chez les patients adhérents après un régime de huit semaines.
Le traitement a montré une efficacité de 95% dans la population globale évaluable, y compris les patients non adhérents. Le régime s'est généralement avéré sûr, sans événements indésirables graves liés au médicament. Les patients non cirrhotiques ont atteint un taux de succès de 99%, tandis que les patients cirrhotiques ont montré une efficacité de 88%.
La société prévoit de lancer un programme de phase 3 début 2025, suite à une réunion avec la FDA. La prochaine phase comportera un comprimé de combinaison à dose fixe, réduisant la prise quotidienne de quatre à deux comprimés.
Atea Pharmaceuticals (NASDAQ: AVIR) hat positive Ergebnisse aus der Phase-2-Studie für seine HCV-Behandlung, die bemnifosbuvir und ruzasvir kombiniert, bekannt gegeben. Die Studie erfüllte ihre primären Endpunkte mit einer 98% nachhaltigen virologischen Reaktion nach 12 Wochen nach der Behandlung bei therapietreuen Patienten nach einem achtwöchigen Regime.
Die Behandlung zeigte eine 95% Wirksamkeit in der insgesamt bewertbaren Bevölkerungsgruppe, einschließlich nicht-adhärenter Patienten. Das Regime war im Allgemeinen sicher und es gab keine schwerwiegenden unerwünschten Ereignisse im Zusammenhang mit dem Medikament. Nicht-zirrhotische Patienten erreichten eine 99% Erfolgsquote, während zirrhotische Patienten eine Wirksamkeit von 88% aufwiesen.
Das Unternehmen plant, Anfang 2025 ein Phase-3-Programm zu starten, nachdem ein Treffen mit der FDA stattgefunden hat. In der kommenden Phase wird eine Tablette mit fester Dosis-Kombination vorgestellt, die die tägliche Pillenzahl von vier auf zwei reduziert.
- 98% success rate in treatment-adherent patients
- 95% efficacy in overall evaluable population including non-adherent patients
- 99% success rate in non-cirrhotic patients
- No drug-related serious adverse events reported
- Planned reduction in pill burden from 4 to 2 tablets daily for Phase 3
- Lower efficacy rate (88%) in cirrhotic patients
- Phase 3 trials not starting until early 2025
Insights
The Phase 2 results for Atea's HCV treatment combination are remarkably strong. The 98% SVR12 rate in treatment-adherent patients after just 8 weeks is highly competitive with current standard-of-care treatments. Even more impressive is the 95% success rate in the broader population including non-adherent patients, demonstrating robust drug forgiveness - a important factor for real-world effectiveness.
The pan-genotypic efficacy across genotypes 1-4 in non-cirrhotic patients (99% SVR12) positions this regimen favorably in the HCV market. The planned reduction to two tablets daily with no food restrictions addresses key convenience factors that influence treatment success. While the 88% SVR12 in cirrhotic patients led to extending their treatment to 12 weeks, this affects only an estimated 10% of the target population.
This development represents a significant market opportunity for Atea. The HCV market remains substantially underserved, with new diagnoses outpacing treatment rates. The combination of shorter treatment duration (8 weeks vs typical 12 weeks), simplified dosing and strong efficacy could drive substantial market adoption.
With Phase 3 initiation expected in early 2025 following FDA discussions, Atea is positioned to potentially capture meaningful market share in the
Primary Endpoint Achieved with
Regimen Was Generally Safe and Well-Tolerated
Global Phase 3 Program Initiation Expected Early in 2025
BOSTON, Dec. 04, 2024 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea” or “Company”), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today announced that the Company’s Phase 2 study of the regimen of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, for treatment of hepatitis C virus (HCV) met its primary endpoints of safety and sustained virologic response at 12 weeks post-treatment (SVR12).
Primary endpoint results demonstrated a
“These high SVR12 results with only eight weeks of treatment with our regimen are extremely exciting and very significant given the unmet needs for today’s HCV patients. We are eager to discuss our program with regulators, including the U.S. Food and Drug Administration, to promptly advance to Phase 3 development early next year,” said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea. “The HCV market continues to be underserved, and HCV diagnoses in the U.S. outpace treatment rates annually. Our regimen has a potential best-in-class profile that includes the key features for successfully treating today’s HCV patients including convenience, low risk for drug-drug interactions and short treatment duration. We believe that this regimen has the potential to play a major role in the eradication of HCV in the U.S.”
In the Phase 2 study,
“I’ve experienced first-hand the changing population of HCV patients and the increasing importance of short duration therapy,” said Eric Lawitz, MD, The Texas Liver Institute, Clinical Professor of Medicine, University of Texas Health San Antonio. “Our current HCV patients are younger, and frequently taking concurrent medications for their comorbidities. More recently, there are also fewer patients presenting with cirrhosis. I’m encouraged by these promising Phase 2 results and look forward to the Phase 3 program.”
Atea is currently preparing for the Phase 3 program, which is expected to follow an End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) anticipated for early 2025. It is expected that the Phase 3 program will use a fixed dose combination (FDC) tablet reducing the daily pill count from four to two tablets, enhancing patient convenience, with no food effect.
About the Phase 2 Study
The global Phase 2 study enrolled 275 treatment-naïve patients, both with and without compensated cirrhosis. The study was designed to evaluate the safety and efficacy of eight weeks of treatment with the regimen consisting of once-daily bemnifosbuvir 550 mg and ruzasvir 180 mg.
The primary endpoints of the study are safety and SVR12 in the per-protocol treatment adherent population. Secondary and other endpoints include SVR12 in the per-protocol population regardless of treatment adherence (efficacy evaluable), virologic failure and resistance.
About Bemnifosbuvir and Ruzasvir for Hepatitis C Virus (HCV)
Bemnifosbuvir has been shown in in vitro studies to be approximately 10-fold more active than sofosbuvir (SOF), against a panel of laboratory strains and clinical isolates of HCV GT 1–5. In vitro studies have also demonstrated bemnifosbuvir remained fully active against SOF resistance-associated substitutions (S282T), with up to 58-fold more potency than SOF. The pharmacokinetic (PK) profile of bemnifosbuvir supports once-daily dosing for the treatment of HCV. Bemnifosbuvir has been shown to have a low risk for drug-drug interactions. Bemnifosbuvir has been administered to over 2,200 subjects and has been well-tolerated at doses up to 550 mg for durations up to 12 weeks in healthy subjects and patients.
Ruzasvir has demonstrated highly potent and pan-genotypic antiviral activity in preclinical (picomolar range) and clinical studies. Ruzasvir has been administered to over 1,500 HCV-infected patients at daily doses of up to 180 mg for 12 weeks and has demonstrated a favorable safety profile. The PK profile of ruzasvir supports once-daily dosing.
About Hepatitis C Virus (HCV)
Hepatitis C virus (HCV) is a blood-borne, positive-sense, single-stranded (ss) RNA virus that primarily infects liver cells. HCV is a leading cause of chronic liver disease and liver transplants, spreading via blood transfusion, hemodialysis and needle sticks. An estimated 50 million people globally live with chronic HCV infection, with approximately 1 million new infections and 242,000 deaths occurring each year. Most HCV-related deaths are due to liver scarring (cirrhosis) and liver cancer (hepatocellular carcinoma). Injection drug use accounts for around
About Atea Pharmaceuticals
Atea is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral antiviral therapies to address the unmet medical needs of patients with serious viral infections. Leveraging Atea’s deep understanding of antiviral drug development, nucleos(t)ide chemistry, biology, biochemistry and virology, Atea has built a proprietary nucleos(t)ide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of serious viral diseases. Atea plans to continue to build its pipeline of antiviral product candidates by augmenting its nucleos(t)ide platform with other classes of antivirals that may be used in combination with its nucleos(t)ide product candidates. Our lead program and current focus is on the development of the fixed dose combination regimen of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, to treat HCV. For more information, please visit www.ateapharma.com.
Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include but are not limited to the anticipated advancement of the program into Phase 3 clinical development and potential contribution of the regimen of bemnifosbuvir and ruzasvir to the goal of elimination of HCV in the U.S. When used herein, words including “will,” “plans”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Atea’s current expectations and various assumptions. Atea believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Atea may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, dependence on the success of Atea’s most advanced product candidates, in particular the combination of bemnifosbuvir and ruzasvir for the treatment of hepatitis C; as well as the other important factors discussed under the caption “Risk Factors” in Atea’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While Atea may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing Atea’s views as of any date subsequent to the date of this press release.
Contacts
Jonae Barnes
SVP, Investor Relations and Corporate Communications
617-818-2985
Barnes.jonae@ateapharma.com
Will O’Connor
Precision AQ
212-362-1200
will.oconnor@precisionaq.com
FAQ
What were the Phase 2 results for Atea's HCV treatment (AVIR)?
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