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Atea Pharmaceuticals to showcase positive hepatitis C treatment results at EASL 2025
Atea Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, announced that the full results from the PhaseII2 clinical study of Atea’s regimen of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, for the treatment of hepatitis C virus (HCV) infection will be presented at the European Association for the Study of the Liver (EASL) Congress 2025. In addition, pharmacokinetic and safety results supporting the regimen’s profile will also be presented. The EASL Congress 2025 will take place May 7-10 in Amsterdam, Netherlands.
The abstract detailing the results of the Phase II clinical trial (TOP-251) was identified by the EASL Congress as a top poster and selected for the “Poster Tour: Viral Hepatitis C: Clinical Aspects Including Follow Up After SVR & Therapy and Resistance” which also allows the poster to be displayed throughout the entire time of the event. The presentation of the full Phase 2 clinical results will highlight the efficacy and safety of the regimen of bemnifosbuvir and ruzasvir and its potential best-in-class profile, which includes short treatment duration, low risk for drug-drug interactions and convenience with no food effect. Atea has previously announced that the PhaseII2 clinical trial met its primary endpoints of efficacy and safety.
“Atea is dedicated to developing a best-in-class regimen addressing the diverse needs of individuals living with hepatitis C,” said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and founder of Atea Pharmaceuticals.
“Following our successful Phase II study and the recent initiation of our global Phase III program, we look forward to delivering the regimen of bemnifosbuvir and ruzasvir which we believe has the potential to increase the number of HCV patients that are treated and cured. Untreated chronic HCV can have a profound impact on patients’ lives, as well as the associated healthcare and hospitalization costs, as the disease progresses in some cases to liver cancer.”
Despite the availability of direct-acting antivirals, HCV continues to be a significant global health burden. 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. Chronic HCV infection is the leading cause of liver cancer in the US, Europe and Japan.
The accepted abstracts will become available on the EASL Congress 2025 website following the embargo lift on Wednesday, April 23rd at 8:00 AM Central European Time (CEST). Details for the EASL Congress 2025 presentations are as follows:
Poster ID: TOP-251
Title: Efficacy and Safety of Bemnifosbuvir and Ruzasvir after 8 Weeks of Treatment in Patients with Chronic Hepatitis C Virus (HCV) Infection
Presenting Author: Alina Jucov
Date and Time: Wednesday, May 7th, 8:30 AM CEST through Saturday, May 10th, 12:45 PM -1:45 PM CEST, Poster Tour May 10th, 12:45 PM -1:45 PM CEST, Track Hub 5 – Viral Hepatitis
Poster ID: WED-278
Title: Pharmacokinetics of Bemnifosbuvir in Participants with Hepatic Impairment
Presenting Author: Xiao-Jian Zhou
Date and Time: Wednesday, May 7th, 8:30 AM – 5:00 PM CEST
Poster ID: WED-279
Title: No Drug-Drug Interaction (DDI) Between Bemnifosbuvir/Ruzasvir and Bictegravir/Emtricitabine/Tenofovir Alafenamide
Presenting Author: Xiao-Jian Zhou
Date and Time: Wednesday, May 7th, 8:30 AM – 5:00 PM CEST
Poster ID: WED-280
Title: Pharmacokinetics of Bemnifosbuvir in Participants with Renal Impairment
Presenting Author: Xiao-Jian Zhou
Date and Time: Wednesday, May 7th, 8:30 AM – 5:00 PM CEST
HCV KOL Investor Event at 10:00 AM ET on May 14, 2025
Following the EASL Congress 2025, Atea will host a virtual key opinion leader (KOL) investor event with a panel of HCV experts and prescribers on Wednesday, May 14, 2025, at 10:00 AM ET. To register, click here.
About the Phase III C-BEYOND and C-FORWARD Trials in Adults with Chronic HCV
As a part of its Phase 3 registrational program, Atea is conducting two open-label Phase 3 trials, C-BEYOND in the US and Canada which is currently enrolling patients, and C-FORWARD, a global trial outside of North America which is expected to begin enrollment of patients in Q2 2025. 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. The initiation of the Phase III program follows a successful engagement with the FDA at an End-of-Phase II meeting in January 2025, shortly after the Company announced that its Phase II study evaluating the potential best-in-class regimen of bemnifosbuvir and ruzasvir met its primary endpoints of safety and SVR12.
