Atea Pharmaceuticals Unveils Promising Hepatitis C Treatment Data at EASL 2024

Atea Pharmaceuticals, Inc., a leading clinical-stage biopharmaceutical company focused on developing oral antiviral therapeutics for serious viral diseases, is set to present new efficacy data from an ongoing Phase 2 clinical trial on hepatitis C virus (HCV) treatments. The data will be disclosed at the European Association for the Study of the Liver (EASL) Congress 2024, scheduled for June 5-8 in Milan, Italy.

The company's study centers on the combination of bemnifosbuvir, an oral nucleotide NS5B polymerase inhibitor, and ruzasvir, an oral NS5A inhibitor, for treating HCV. The presentation will include SVR12 data, the primary endpoint, from the Phase 2 lead-in cohort. In addition to clinical findings, preclinical data demonstrating bemnifosbuvir's high resistance barrier and pharmacokinetics and ruzasvir's minimal drug-drug interaction potential will also be showcased.

Jean-Pierre Sommadossi, PhD, CEO and founder of Atea Pharmaceuticals, emphasized the need for new HCV treatments, stating that existing therapies have not sufficiently eradicated the virus in the U.S. He noted that the virus and patient demographics have evolved, necessitating treatments with high antiviral potency, short treatment durations, minimal drug interactions, and robust resistance barriers. Sommadossi expressed optimism that their upcoming data presentation would highlight the potential of the bemnifosbuvir and ruzasvir combination to meet these needs.

HCV continues to affect over 2 million people in the U.S., with approximately 100,000 new cases diagnosed annually. The virus persists in various genotypes, with genotype 1 being the most common. Some genotypes, such as genotype 3, pose treatment challenges due to their ability to mutate and resist existing drugs.

The EASL Congress presentations include several key posters. On June 6, Dr. Alina Jucov will present data from the lead-in cohort of an 8-week treatment regimen with bemnifosbuvir and ruzasvir. On June 8, Dr. Qi Huang will present on bemnifosbuvir’s antiviral profile and resistance barrier, followed by Dr. Alex Vo presenting data on bemnifosbuvir's pharmacokinetics and ruzasvir's drug interaction studies.

Bemnifosbuvir is designed to inhibit viral replication by targeting viral RNA polymerase, crucial for the replication of single-stranded RNA viruses like HCV. Ruzasvir, acting as an NS5A inhibitor, complements bemnifosbuvir by enhancing antiviral activity. Together, they offer synergistic effects without significant pharmacokinetic interactions, supporting once-daily dosing.

Preclinical studies have shown bemnifosbuvir's tenfold greater activity compared to sofosbuvir against various HCV strains and its efficacy against sofosbuvir-resistant strains. Ruzasvir has demonstrated potent antiviral activity and has been safe in clinical trials involving over 1,200 HCV patients.

Atea's Phase 2 global clinical trial involves up to 280 treatment-naïve HCV patients, both with and without cirrhosis. The primary endpoints include safety and sustained virologic response at 12 weeks post-treatment (SVR12). Results from an initial cohort of 60 patients showed a 98% SVR4 rate, indicating promising efficacy.

Atea Pharmaceuticals continues to focus on developing antiviral therapies for serious viral infections, leveraging their expertise in nucleos(t)ide chemistry and virology. Their goal is to address unmet medical needs through innovative treatments, including therapies for HCV and SARS-CoV-2, the virus responsible for COVID-19.