Today, Atea Pharmaceuticals announced further data from its ongoing phase 2 trial, which showed its combination investigational antiviral, bemnifosbuvir (BEM, AT-527) and ruzasvir (RZR) for the treatment of hepatitis C (HCV) reached a 97% sustained virologic response at week 12 (SVR12), and it is the primary endpoint of the study.
Results from this lead-in cohort of 60 participants in the phase 2 study also showed a 100% SVR12 rate in participants infected with genotype 3 (n=13), a historically difficult-to-treat genotype of HCV. The combination regimen was well tolerated, with no drug-related severe adverse events or treatment discontinuations.
“I am excited about the initial bemnifosbuvir and ruzasvir combination data,” said Eric Lawitz, MD, The Texas Liver Institute, Clinical Professor of Medicine, University of Texas Health San Antonio. “The combination of a short 8-week treatment duration, a low risk of drug-drug interactions, and robust antiviral efficacy across all genotypes makes this an attractive regimen.”
The data is being presented at this week’s European Association for the Study of the Liver (EASL) Congress taking place June 5-8, in Milan, Italy. Atea will be presenting posters on the combination viral at the conference.
“Today, new challenges are hindering progress towards our goal of HCV elimination in the US and globally. Patient demographics have changed, and the pace of new HCV infections is quickly outpacing the rate of those being treated. It is apparent that further innovations are required to address the needs of today’s HCV-infected patients,” Atea CEO Jean-Pierre Sommadossi, PhD, said in a statement.
Atea is a Boston-based, clinical-stage biopharmaceutical company engaged in the development of oral antiviral therapeutics for viral diseases. They also have an investigational COVID-19 therapy in clinical trials.
[Read More: The Means for Curative Hepatitis C Care are Available, But Many Still Don’t Utilize]
What You Need to Know
Atea Pharmaceuticals presented data at the European Association for the Study of the Liver (EASL) Congress showing a 97% sustained virologic response (SVR12) at 12 weeks post-treatment with their investigational antiviral combination of bemnifosbuvir (BEM, AT-527) and ruzasvir (RZR).
The phase 2 trial included a lead-in cohort of 60 participants, with a notable 100% SVR12 rate in those infected with genotype 3 HCV, a historically difficult-to-treat genotype.
The company aims to continue its phase 2 study with an expanded cohort of up to 220 subjects, including those with compensated cirrhosis, and plans to report full results later in the year.
The Challenges Associated With HCV Care
For people with HCV, there are a few challenges associated with getting them into care. Called the silent killer, hepatitis C can be asymptomatic for years, and without any acute health issues, this might prevent some people from seeking care. Some individuals with HCV may inject drugs, be underinsured, homeless, and have other socioeconomic issues and only use health care sparingly, if at all.
“Today, many of my HCV patients present with other conditions requiring multiple concurrent therapies and complicated lives,” Lawitz stated.
Further Data
Based on these positive data from the lead-in cohort, the phase 2 study will continue with the goal to enroll up to an additional 220 subjects, including those with compensated cirrhosis. “We look forward to reporting the full results from our ongoing phase 2 study during the second half of this year,” said Sommadossi.
Reference
Atea Pharmaceuticals Announces Presents Positive Initial Phase 2 Data for Bemnifosbuvir and Ruzasvir Combination for Treatment of Hepatitis C Virus at EASL Congress 2024. Atea Pharmaceuticals press release. June 5, 2024. Accessed June 5, 2024. https://ir.ateapharma.com/news-releases/news-release-details/atea-pharmaceuticals-presents-positive-initial-phase-2-data
