Atea Pharmaceuticals Presents Multiple New Datasets Supporting the Combination of Bemnifosbuvir and Ruzasvir for the Treatment of Hepatitis C Virus at AASLD’s The Liver Meeting 2024
Atea Pharmaceuticals (AVIR) presented three posters at AASLD's The Liver Meeting 2024 supporting the combination of bemnifosbuvir and ruzasvir for hepatitis C virus (HCV) treatment. The Phase 2 lead-in cohort showed a 97% SVR12 success rate with an 8-week treatment course. Key findings include: the drug combination effectively blocks viral replication and assembly, bemnifosbuvir demonstrates no clinically relevant effects on cardiac function, and shows a high barrier to resistance. The company plans to report full Phase 2 results in early December and initiate Phase 3 development in early 2025.
Atea Pharmaceuticals (AVIR) ha presentato tre poster all'AASLD's The Liver Meeting 2024 a sostegno della combinazione di bemnifosbuvir e ruzasvir per il trattamento dell'infezione da virus dell'epatite C (HCV). La coorte di lead-in della Fase 2 ha mostrato un 97% di tasso di successo SVR12 con un ciclo di trattamento di 8 settimane. I risultati chiave includono: la combinazione di farmaci blocca efficacemente la replicazione e l'assemblaggio virale, il bemnifosbuvir non presenta effetti clinicamente rilevanti sulla funzione cardiaca e mostra un'elevata barriera alla resistenza. La società prevede di riportare i risultati completi della Fase 2 all'inizio di dicembre e di avviare lo sviluppo della Fase 3 all'inizio del 2025.
Atea Pharmaceuticals (AVIR) presentó tres carteles en la reunión The Liver Meeting 2024 de AASLD, apoyando la combinación de bemnifosbuvir y ruzasvir para el tratamiento del virus de la hepatitis C (VHC). La cohorte de lead-in de Fase 2 mostró una tasa de éxito SVR12 del 97% con un curso de tratamiento de 8 semanas. Los hallazgos clave incluyen: la combinación de medicamentos bloquea efectivamente la replicación y ensamblaje viral, el bemnifosbuvir no demuestra efectos clínicamente relevantes sobre la función cardíaca y presenta una alta barrera a la resistencia. La empresa planea informar los resultados completos de la Fase 2 a principios de diciembre e iniciar el desarrollo de la Fase 3 a principios de 2025.
Atea Pharmaceuticals (AVIR)는 AASLD의 The Liver Meeting 2024에서 bemnifosbuvir와 ruzasvir의 간염 C 바이러스(HCV) 치료를 위한 조합을 지지하는 세 개의 포스터를 발표했습니다. 2상 리드인 코호트는 8주 치료 과정에서 97% SVR12 성공률을 보였습니다. 주요 결과로는: 약물 조합이 바이러스 복제와 조립을 효과적으로 차단하고, bemnifosbuvir가 심장 기능에 대한 임상적으로 유의미한 영향을 미치지 않으며, 저항에 대한 높은 장벽을 나타냅니다. 회사는 12월 초에 전체 2상 결과를 보고할 예정이며, 2025년 초에 3상 개발을 시작할 계획입니다.
Atea Pharmaceuticals (AVIR) a présenté trois affiches lors de la réunion The Liver Meeting 2024 de l'AASLD soutenant la combinaison de bemnifosbuvir et ruzasvir pour le traitement de l'infection par le virus de l'hépatite C (VHC). La cohorte de lancement de la phase 2 a montré un taux de succès SVR12 de 97% avec un traitement de 8 semaines. Les résultats clés incluent : la combinaison de médicaments bloque efficacement la réplication et l'assemblage viral, le bemnifosbuvir ne montre aucun effet cliniquement pertinent sur la fonction cardiaque et présente une forte barrière à la résistance. La société prévoit de communiquer les résultats complets de la phase 2 début décembre et de commencer le développement de la phase 3 début 2025.
Atea Pharmaceuticals (AVIR) präsentierte drei Poster auf dem AASLD The Liver Meeting 2024, die die Kombination von bemnifosbuvir und ruzasvir zur Behandlung des Hepatitis-C-Virus (HCV) unterstützen. Die Lead-in-Kohorte der Phase 2 zeigte eine 97% SVR12 Erfolgsrate mit einem 8-wöchigen Behandlungsverlauf. Wichtige Ergebnisse beinhalten: die Arzneimittelkombination blockiert wirksam die virale Replikation und Assemblierung, bemnifosbuvir zeigt keine klinisch relevanten Auswirkungen auf die Herzfunktion und weist eine hohe Widerstandsfähigkeit gegenüber Resistenzen auf. Das Unternehmen plant, die vollständigen Phase-2-Ergebnisse Anfang Dezember zu berichten und die Phase-3-Entwicklung Anfang 2025 zu initiieren.
- Phase 2 lead-in cohort achieved 97% SVR12 success rate
- Drug combination demonstrates effectiveness in blocking viral replication and assembly
- Bemnifosbuvir shows high barrier to resistance with minimal amino acid changes
- No cardiac safety concerns identified in QT study
- Phase 3 development planned for early 2025
- None.
Insights
The Phase 2 clinical trial data for Atea's HCV treatment combination shows promising efficacy with a
The multiscale modeling data validates the clinical effectiveness, while the resistance profile study suggests minimal risk of viral mutations. These findings position the treatment favorably in the competitive HCV market, where shorter treatment durations and better safety profiles are key differentiators. The potential for reduced treatment duration could significantly improve patient compliance and reduce healthcare costs.
This development represents a significant opportunity in the $4.7 billion global HCV market. The combination therapy's potential best-in-class profile, particularly the shorter treatment duration and favorable drug interaction profile, could capture substantial market share from current standard-of-care treatments. The positive cardiac safety profile and high barrier to resistance address key concerns that often limit the adoption of new antivirals.
With Phase 3 trials planned for early 2025, Atea is positioned to potentially launch this product within the next 2-3 years, assuming successful trials and regulatory approval. This could significantly impact Atea's market position, especially given their current market cap of
BOSTON, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today presented three poster presentations supporting the combination of bemnifosbuvir and ruzasvir as a potential treatment for hepatitis C virus (HCV). The combination of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, is in Phase 2 development for the treatment of HCV. These data are being presented at the American Association for the Study of Liver Diseases’ (AASLD) The Liver Meeting 2024, being held from November 15-19, 2024 in San Diego, CA.
“These important data presented today at The Liver Meeting add to the growing body of evidence supporting the combination of bemnifosbuvir and ruzasvir and its potential best-in-class profile for the treatment of HCV,” said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals. “We expect to report results from our Phase 2 study of the combination of bemnifosbuvir and ruzasvir in early December and we look forward to initiating Phase 3 development in early 2025. Our combination includes the most compelling attributes of current HCV drug treatments such as convenience, low risk for drug-drug interactions, as well as short duration, which is further supported by the viral kinetic modeling results presented today. We believe our combination has the potential to address current treatment challenges and unmet needs and to play a major role in the eradication of HCV.”
“A multiscale model of HCV infection and treatment was designed to estimate the in vivo effectiveness of agents including various combinations of direct-acting antivirals to block HCV replication and viral assembly,” said Alan Perelson, PhD, Senior Fellow at Los Alamos National Laboratory. “The data presented today modeling the combination of bemnifosbuvir and ruzasvir for the treatment of HCV align with the reported clinical results from the lead-in cohort of the Phase 2 study. These data are highly encouraging and show a SVR12 rate of
Poster Number: 1467
Date and Time: Friday, November 15, 1:00 p.m. – 2:00 p.m. PT
Location: San Diego Convention Center
Title: Multiscale Modeling of Lead-in Results from a Phase 2 Study of an 8-Week Combination Regimen of Bemnifosbuvir and Ruzasvir in Patients with Chronic Hepatitis C Virus Infection
Presenter: Ruy M. Ribeiro, PhD
A multiscale HCV viral kinetic model was utilized to estimate the clinical effectiveness of the combination of bemnifosbuvir and ruzasvir in blocking HCV replication and viral assembly/secretion against HCV. This model evaluated the combination of bemnifosbuvir and ruzasvir in the lead-in cohort (n=60) of a Phase 2 single-arm study. This cohort was comprised of treatment-naïve, non-cirrhotic patients with chronic HCV receiving 550 mg bemnifosbuvir once daily (QD) and 180 mg ruzasvir QD for 8 weeks. The multiscale model was fit to the plasma viral load (VL) and the alanine aminotransferase (ALT) data from all 60 subjects simultaneously through mixed-effects population fitting.
The modeling results provided insight on the mechanism of action and demonstrated that the combination of bemnifosbuvir and ruzasvir was highly effective in blocking both viral replication and viral assembly/secretion in HCV-infected patients, independent of genotype, age, sex, or fibrosis score. A high sustained virologic response at 12 weeks post-treatment (SVR12) rate of
Poster Number: 1466
Date and Time: Friday, November 15, 1:00 p.m. – 2:00 p.m. PT
Location: San Diego Convention Center
Title: Bemnifosbuvir Does Not Alter Cardiac Repolarization in Healthy Participants: Results from a Thorough QT Study
Presenter: Xiao-Jian Zhou, PhD
Bemnifosbuvir had no clinically relevant effects on cardiac repolarization, heart rate, PR interval, or QRS duration (all related to heart function) in healthy volunteers (n=38). A QTc effect exceeding 10 milliseconds, the established threshold of concern, can be excluded across the observed plasma concentrations of bemnifosbuvir and its metabolites at the therapeutic and supratherapeutic doses.
Poster Number: 1501
Date and Time: Friday, November 15, 1:00 p.m. – 2:00 p.m. PT
Location: San Diego Convention Center
Title: Bemnifosbuvir Poses High Barrier for Resistance in Both Preclinical and Phase 1b Monotherapy Studies
Presenter: Qi Huang, PhD
Next generation sequencing was performed to determine bemnifosbuvir resistant substitutions in a Phase 1b study (n=42) that had demonstrated potent antiviral activity of bemnifosbuvir when used as a monotherapy in HCV genotype 1b, 2a and 3a infected patients. Time-related, dose-related, and exposure-related decreases in HCV RNA were observed after multiple doses of bemnifosbuvir. The pre-existing NS5B non-nucleoside resistance-associated substitutions at baseline did not correlate to bemnifosbuvir antiviral activity based on the maximum HCV RNA reduction of each subject. The changes of amino acid percentage in on-treatment samples were generally minimal, within 1
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 combination 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 date and time of the presentations at The Liver Meeting, the anticipated timing for reporting of the results from Atea’s Phase 2 clinical trial of the combination of bemnifosbuvir and ruzasvir in the treatment of hepatitis C and the anticipated advancement of the program into Phase 3 clinical development. When used herein, words including “expect,” “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
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