Atea Pharmaceuticals to Present New Data Supporting the Combination of Bemnifosbuvir and Ruzasvir for the Treatment of Hepatitis C Virus at AASLD’s The Liver Meeting 2024
Atea Pharmaceuticals (NASDAQ: AVIR) announced three upcoming poster presentations at AASLD's The Liver Meeting 2024 in San Diego, showcasing new data on the combination of bemnifosbuvir and ruzasvir for Hepatitis C Virus (HCV) treatment. The combination, currently in Phase 2 development, pairs a nucleotide analog polymerase inhibitor with an NS5A inhibitor.
The presentations, scheduled for November 15, will cover multiscale modeling of Phase 2 study results, cardiac repolarization effects, and resistance barrier studies. The company aims to address unmet needs in HCV treatment, particularly for patients with substance abuse disorders and comorbidities, and plans to advance to Phase 3 development following Phase 2 results later this year.
Atea Pharmaceuticals (NASDAQ: AVIR) ha annunciato tre presentazioni di poster in programma alla AASLD's The Liver Meeting 2024 a San Diego, dove presenterà nuovi dati sulla combinazione di bemnifosbuvir e ruzasvir per il trattamento dell'Hepatitis C Virus (HCV). Questa combinazione, attualmente in fase di sviluppo Fase 2, unisce un inibitore della polimerasi ad analogo nucleotidico con un inibitore NS5A.
Le presentazioni, previste per il 15 novembre, riguarderanno la modellizzazione multiscala dei risultati dello studio di Fase 2, gli effetti sulla ripolarizzazione cardiaca e gli studi sulla barriera alla resistenza. L'azienda punta a rispondere ai bisogni insoddisfatti nel trattamento dell'HCV, in particolare per i pazienti con disturbi da uso di sostanze e comorbidità, e prevede di avanzare alla Fase 3 dopo i risultati della Fase 2 entro la fine di quest'anno.
Atea Pharmaceuticals (NASDAQ: AVIR) anunció tres presentaciones de carteles próximas en AASLD's The Liver Meeting 2024 en San Diego, mostrando nuevos datos sobre la combinación de bemnifosbuvir y ruzasvir para el tratamiento del Virus de la Hepatitis C (HCV). La combinación, que actualmente se encuentra en desarrollo de Fase 2, combina un inhibidor de la polimerasa análogo de nucleótidos con un inhibidor de NS5A.
Las presentaciones, programadas para el 15 de noviembre, cubrirán el modelado multiescalar de los resultados del estudio de Fase 2, los efectos de la repolarización cardíaca y los estudios de barrera de resistencia. La empresa busca abordar las necesidades no satisfechas en el tratamiento del HCV, especialmente para pacientes con trastornos por abuso de sustancias y comorbilidades, y planea avanzar a la Fase 3 después de los resultados de la Fase 2 más adelante este año.
Atea Pharmaceuticals (NASDAQ: AVIR)는 샌디에이고에서 개최되는 AASLD's The Liver Meeting 2024에서 새로운 데이터를 발표하며, bemnifosbuvir와 ruzasvir의 조합을 통해 간염 C 바이러스(HCV) 치료에 대한 포스터 발표를 세 차례 진행한다고 발표했습니다. 현재 Fase 2 개발 중인 이 조합은 뉴클레오타이드 유사체 폴리메라제 억제제와 NS5A 억제제를 결합하고 있습니다.
11월 15일로 예정된 발표에서는 Fase 2 연구 결과의 다중 척도 모델링, 심장 재분극 효과 및 저항 장벽 연구를 다룰 예정입니다. 이 회사는 HCV 치료에서 충족되지 않은 요구를 다루고자 하며, 특히 물질 남용 장애 및 동반질환이 있는 환자들을 위해 Fase 2 결과 이후 올해 말 Fase 3 개발로 나아갈 계획입니다.
Atea Pharmaceuticals (NASDAQ: AVIR) a annoncé trois futures présentations d'affiches lors de AASLD's The Liver Meeting 2024 à San Diego, présentant de nouvelles données sur la combinaison de bemnifosbuvir et ruzasvir pour le traitement du virus de l'hépatite C (VHC). Cette combinaison, actuellement en développement de Phase 2, associe un inhibiteur de la polymérase analogue des nucléotides avec un inhibiteur NS5A.
Les présentations, prévues pour le 15 novembre, couvriront la modélisation multi-échelle des résultats de l'étude de Phase 2, les effets de la repolarisation cardiaque et les études de barrière de résistance. L'entreprise vise à répondre aux besoins non satisfaits dans le traitement du VHC, en particulier pour les patients souffrant de troubles liés à l'usage de substances et de comorbidités, et prévoit de passer au développement de Phase 3 après les résultats de la Phase 2 plus tard cette année.
Atea Pharmaceuticals (NASDAQ: AVIR) hat drei bevorstehende Posterpräsentationen auf AASLD's The Liver Meeting 2024 in San Diego angekündigt, bei denen neue Daten zur Kombination von bemnifosbuvir und ruzasvir zur Behandlung des Hepatitis-C-Virus (HCV) präsentiert werden. Die Kombination, die sich derzeit in der Phase-2-Entwicklung befindet, vereint einen Nukleotid-Analog-Polymerasehemmer mit einem NS5A-Hemmer.
Die Präsentationen, die für den 15. November geplant sind, werden die multiskalige Modellierung der Ergebnisse der Phase-2-Studie, die Effekte der kardialen Repolarisation und Studien zur Widerstandsbarriere behandeln. Das Unternehmen zielt darauf ab, unbeantwortete Bedürfnisse in der HCV-Behandlung anzusprechen, insbesondere für Patienten mit Substanzmissbrauchsstörungen und Begleiterkrankungen, und plant, nach den Ergebnissen der Phase 2 später in diesem Jahr in die Phase 3 Entwicklung überzugehen.
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BOSTON, Oct. 30, 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 announced three upcoming 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 HCV. These data will be 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.
“We look forward to presenting these important data, which support 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. “The unrelenting high incidence rate of HCV infections underscores the need for new therapies that can address the unmet needs of today’s HCV patients, particularly those with substance abuse disorders and comorbidities. We look forward to reporting results from our Phase 2 study later this year and to advancing this program into Phase 3 development.”
Details for the AASLD’s The Liver Meeting presentations are as follows:
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
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
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
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 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 “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 June 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
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