Panel to Discuss Current Challenges Encountered by Patients with HCV, Results from Atea’s Phase 2 Study of the Regimen of Bemnifosbuvir and Ruzasvir, and What a New Optimized HCV Therapy Could Provide for Prescribers and Patients
Event to Replace Atea’s First Quarter 2025 Earnings Conference Call; Quarterly Calls to Resume with Second Quarter 2025 Financial Results
BOSTON, May 01, 2025 (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 it will virtually host a hepatitis C virus (HCV) key opinion leader (KOL) panel discussion on topics related to the treatment of HCV on Wednesday, May 14, 2025 at 10:00 AM ET. Atea also announced that it plans to issue a press release and report its first quarter 2025 financial results after the market closes on Monday, May 12, 2025. Atea will not host a first quarter conference call and plans to resume the quarterly calls with the second quarter 2025 financial results.
To register for the virtual HCV KOL event, please click here.
The event will feature several KOLs including:
- Eric Lawitz, MD - Texas Liver Institute, University of Texas Health San Antonio, US
- Anthony Martinez, MD - University of Buffalo, Erie County Medical Center, US
- David Wyles, MD, FIDSA - University of Colorado, Denver Health Medical Center, US
- Tarik Asselah, MD, PhD - Hôpital Beaujon, University of Paris-Cité, France
- Joaquin Cabezas, MD - Marques de Valdecilla University Hospital, Santander, Spain
- Jordan Feld, MD, MPH - University of Toronto, Toronto General Hospital, Canada
This event will include a panel of several US and ex-US physicians who are leaders in hepatology, gastroenterology, infectious diseases and HCV treatments. These experts and prescribers will discuss the current challenges encountered by patients with HCV, the results from Atea’s global Phase 2 study evaluating the regimen of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, for the treatment of HCV, and what a new optimized HCV therapy could provide for prescribers and patients. Company management will discuss the HCV commercial market opportunity and the ongoing global Phase 3 clinical development.
A live question and answer session will follow the formal discussion. The event will also be recorded and available under "Events and Presentations" in the Investor Relations section of the Atea Pharmaceuticals website at ir.ateapharma.com. This archive of the event will be available after the presentation and will remain available on Atea’s website for at least 90 days following the event.
About the KOLs
Eric Lawitz, MD is the Medical Director and VP of Research and Development at the Texas Liver Institute and Clinical Professor of Medicine at the University of Texas Health San Antonio in San Antonio, Texas, USA. He began his career by achieving a BS from the University of Illinois and an MD from Rush Medical College, both in Chicago, before receiving postgraduate training in Gastroenterology and Hepatology at Brooke Army Medical Center in San Antonio, Texas, where he subsequently became Chief of Clinical Services. Dr. Lawitz has been awarded numerous awards including the William Beaumont Clinical Research Award. He is board certified in Gastroenterology/Hepatology and is internationally recognized for his research and teaching on liver disease, having presented his research findings at both national and international medical congresses. Dr Lawitz is a Fellow of the American Association for the Study of Liver Diseases (AASLD), American Gastroenterological Association (AGA), and Academy of Physicians in Clinical Research and is a certified Principal Investigator. He serves as a reviewer for numerous journals. He has authored over 500 peer-reviewed publications resulting in more than 44,000 citations. He has published in numerous journals including New England Journal of Medicine, The Lancet, Gastroenterology, Hepatology, and Journal of Hepatology.
Anthony Martinez, MD is an Associate Professor of Medicine at the University at Buffalo and Medical Director of Hepatology at Erie County Medical Center. His clinic, “La Bodega,” has been recognized nationally and internationally as a novel co-localized model for managing liver disease and addiction disorders. Since 2013, the clinic has treated thousands of individuals for HCV and substance use disorder and it has been recognized twice with the New York State World AIDS Day Commissioner’s Special Recognition Award. Dr. Martinez, who has been treating patients with HCV since 2006, has lectured worldwide on HCV management among people with substance use disorders. His team’s work has been presented at the annual liver meeting of the American Association for the Study of Liver Diseases (AASLD), the annual conference of the International Network on Viral Hepatitis in Substance Users, and the International Liver Congress. Dr. Martinez has been a primary and co-investigator on numerous clinical trials related to hepatitis C and fatty liver disease. He is board-certified by the ABIM and the American Academy of HIV Medicine. He is a Fellow of the American Association for the Study of Liver Diseases (AASLD), ambassador and co-chair of the Chronic Liver Disease Foundation HCV Committee, and an inductee in the Gold Humanism Honor Society. In 2024, Dr. Martinez was honored with a Hepatitis Elimination Champion recognition by the Coalition for Global Hepatitis Elimination.
David Wyles, MD, FIDSA is a graduate of Northwestern University Feinberg School of Medicine and currently Professor of Medicine in the Division of Infectious Diseases at the University of Colorado and Chief of the Division of Infectious Diseases at Denver Health Medical Center. Dr. Wyles’ research interests center on viral hepatitis including: the conduct of clinical trials with novel therapeutics for HBV and HCV, HCV drug resistance/retreatment and the treatment of viral hepatitis in the setting of HIV co-infection and in underserved populations. During the COVID-19 pandemic, Dr. Wyles was also involved in clinical trials of novel therapeutics for hospitalized patients with severe COVID-19. Dr. Wyles was an inaugural member and Co-chair of the American Association for the Study of Liver Diseases (AASLD) / Infectious Diseases Society of America (IDSA) HCV guidelines panel and is also a member of the International Antiviral Society – USA Hepatitis Advisory Board. He is a current member of the ACTG Hepatitis transformative science group.
Tarik Asselah, MD, PhD is a Full Professor of Medicine and Hepatology, caring for patients at Hôpital Beaujon, Assitance Publique des Hôpitaux de Paris (AP-HP), Clichy, France, and teaching at the University of Paris-Cité, France. Professor Asselah is the Head of Viral Hepatitis at Institut National de la Santé et de la Recherche Médicale (INSERM ; UMR 1149), Centre de Recherche sur l’Inflammation. He is an MD and also holds a PhD in virology. Professor Asselah’s fields of research include chronic liver diseases, translational medicine, precision medicine, and treatment of viral hepatitis (HBV, HCV and HDV). Professor Asselah is a coordinator/principal investigator for many international clinical trials of therapies for chronic viral hepatitis with particular interest in early phase development (from phase I to III) of new direct acting antiviral therapies. Professor Asselah has coordinated at the international level major international clinical trials on viral hepatitis, such as Solstice (NCT05461170, Vir Biotechnology), MYR-204 (NCT03852433, Gilead), Octopus (NCT05275023, Janssen), and Endurance-4 (NCT02636595, AbbVie) studies. Prof. Asselah was an expert for the European Association for the Study of the Liver (EASL) Clinical Practice Guidelines on hepatitis delta virus in 2023. Professor Asselah has authored more than 300 articles in the field of chronic liver diseases in major journals (The New England Journal of Medicine, The Lancet, Gastroenterology, Hepatology, Journal of Hepatology, etc.) with over 15,000 total citations (H-index = 61). He has been selected as a Rising Star in Gastroenterology in 2009 by the United European Gastroenterology (UEG) in appreciation of his outstanding scientific work. He received awards for his genomic studies on HCV in 2005 from the French Association for Liver Disease (AFEF), and for his leadership in hepatology in 2019 from the Czech Hepatology Society. In 2023, Professor Asselah received the Faculty Outstanding Research Output Award from the Li Ka Shing Faculty of Medicine of Hong Kong. In 2024, Professor Asselah received the Presidential Award from the Asian Pacific Association for the Study of the Liver (APASL) 2024 in Kyoto, Japan.
Joaquin Cabezas, MD is a Gastroenterology and Hepatology physician. He is a staff member in the Gastroenterology and Hepatology Department at Marques de Valdecilla University Hospital, Santander, Spain. He received his Bachelor of Medicine in University of Valladolid (Spain) in 2006. He finished his specialist residence in Marques de Valdecilla University Hospital in 2011. Dr. Cabezas' investigation interests are liver diseases with special focus on viral hepatitis and alcohol-related liver disease. He is a participant in a research group called “Clinical and Translational Research in Digestive Diseases”, which is part of the Research Institute Valdecilla (IDIVAL). In 2015, Dr. Cabezas did one year of translational formation with Dr. Ramon Bataller at the University of North Carolina, Chapel Hill. Current research projects include hepatitis B, C and delta epidemiology, models of care and alcohol-related hepatitis. Dr. Cabezas is also a collaborator in the JailFree-C project, and The HONEST project focused on HCV management in the correctional setting. These studies provide a model of care including a test-and-treat strategy, a navigator/multidisciplinary team/telemedicine tools in an underserved population in prison in Cantabria-Spain. Since the success of these projects, Prof. Javier Crespo and Dr. Cabezas lead the Strategic Plan for hepatitis C elimination in Cantabria. Dr. Cabezas was a member of the INHSU Prison Network in the prison sector from 2019-2024 and is leading the development of a Global Network for Infectious Diseases in Prison.
Jordan Feld, MD, MPH is a Professor of Medicine at the University of Toronto, Section Head, Hepatology, Division of Gastroenterology and Hepatology, University Health Network and holds the Francis Family / Dr. Jenny Heathcote Chair in Liver Research and R. Phelan Chair in Translational Liver Research. Dr. Feld trained in GI and Hepatology at the University of Toronto and did post-doctoral training in the Liver Diseases Branch at the National Institutes of Health in laboratory and clinical research in viral hepatitis. After completing a Masters in Public Health at the Johns Hopkins Bloomberg School of Public Health, he returned to Toronto. Dr. Feld is a clinician-scientist at the Toronto Centre for Liver Disease in the Toronto General Hospital where he leads a large clinical and translational research program focused primarily on viral hepatitis and its complications.
About HCV
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, with 242,000 deaths occurring each year. Despite the availability of direct-acting antivirals, HCV continues to be a significant global healthcare issue. An estimated 50 million people worldwide are chronically infected with HCV and there are approximately one million new infections each year. In the US, between 2.4 and 4 million people are estimated to have HCV with annual new infections outpacing treatment rates. HCV infections in the US predominate in patients in the age group between 20-49 years old, and it is estimated that less than 10% of HCV-infected patients in the US have cirrhosis. Chronic HCV infection is the leading cause of liver cancer in the US, Europe and Japan.
About the Bemnifosbuvir / Ruzasvir HCV Phase 3 Program
Atea is conducting two open-label Phase 3 trials, C-BEYOND in the US and Canada, and C-FORWARD, a global trial outside of North America. Each Phase 3 trial will enroll approximately 880 treatment-naïve patients, including those with and without compensated cirrhosis. The trials will compare the fixed dose combination (FDC) regimen of bemnifosbuvir and ruzasvir to the FDC regimen of sofosbuvir and velpatasvir. The regimen of bemnifosbuvir and ruzasvir will be administered orally once-daily for 8 weeks (in patients without cirrhosis) or 12 weeks (in patients with compensated cirrhosis) while the regimen of sofosbuvir and velpatasvir will be administered orally once-daily for 12 weeks for all patients with or without compensated cirrhosis.
The primary endpoint for each trial is HCV RNA < lower limit of quantitation (LLOQ) at 24 weeks from the start of treatment and encompasses sustained virologic response 12 weeks post-treatment (SVR12) in each arm. Measurement at 24 weeks from the start of treatment is to ensure the primary endpoint occurs at the same relative timepoint from the start of treatment in all patients. While C-BEYOND and C-FORWARD are both open-label trials, Atea has put measures and processes in place that are designed to blind Atea personnel to patient treatment assignments. Patient enrollment for the C-BEYOND trial began in April 2025 and enrollment for C-FORWARD is expected to begin mid-2025.
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 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 regimen of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, to treat hepatitis C virus. 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 statements regarding Atea’s Phase 3 clinical development program, and the date and time of the panel presentation. When used herein, words including “expected,” “should,” “anticipated,” “believe.” “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, repurchases of our common stock may not be conducted in the manner the Company expects; uncertainties inherent in the drug discovery and development process and the regulatory submission or approval process, unexpected or unfavorable safety or efficacy data or results observed during clinical trials or in data readouts; delays in or disruptions to clinical trials or our business; our reliance on third parties over which we may not always have full control, our ability to manufacture sufficient commercial product, competition from approved treatments for HCV, as well as the other important factors discussed under the caption “Risk Factors” in Atea’s Annual Report on Form 10-K for the year ended December 31, 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
Joyce Allaire
LifeSci Advisors
Jallaire@lifesciadvisors.com
