Atea Pharmaceuticals Shares Positive Phase 2 Data for Hepatitis C Treatment at EASL 2024

Atea Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, recently announced promising results from its ongoing Phase 2 study featuring a combination treatment for hepatitis C virus (HCV). This study investigates the efficacy of bemnifosbuvir, an oral nucleotide NS5B polymerase inhibitor, partnered with ruzasvir, an oral NS5A inhibitor. Data from the lead-in cohort of 60 non-cirrhotic patients showed a remarkable 97% sustained virologic response rate at 12 weeks post-treatment (SVR12), which marks the primary efficacy endpoint.

Additionally, the combination therapy demonstrated a 100% SVR12 rate among participants infected with genotype 3, which is notoriously challenging to treat. The regimen was well tolerated with no significant drug-related adverse events or treatment discontinuations. This positive outcome supports the continuation of the Phase 2 study, which aims to enroll up to 220 additional subjects, including patients with compensated cirrhosis.

Preclinical data presented at the European Association for the Study of the Liver (EASL) Congress further underscore the potential of this combination therapy. The data illustrate a high barrier to resistance for bemnifosbuvir and a low risk of drug-drug interactions for ruzasvir. This combination treatment could emerge as a best-in-class option for HCV, especially considering its short 8-week duration and high antiviral potency.

In the context of evolving patient demographics and rising HCV infection rates, Atea CEO and Founder Jean-Pierre Sommadossi highlighted the necessity for innovative treatments to meet modern healthcare demands. He emphasized the potential of bemnifosbuvir and ruzasvir to significantly improve HCV treatment outcomes.

Dr. Eric Lawitz from The Texas Liver Institute expressed enthusiasm about the initial data, noting the combination's advantages such as short treatment duration and low risk of drug interactions. He believes this regimen could significantly benefit patients with complex medical needs who are on multiple concurrent therapies.

The wider implications of this study are significant, given that more than 2 million people in the U.S. live with chronic HCV, and new chronic cases continually outpace the rate of treatment. The combination treatment of bemnifosbuvir and ruzasvir could potentially reverse this trend by offering a highly effective and well-tolerated option.

Key findings presented at the EASL Congress include:
1. Lead-in Cohort Results: The lead-in cohort of 60 patients showed a 97% SVR12 rate with an 8-week treatment duration. The combination exhibited robust antiviral activity across different genotypes and was well tolerated with no severe adverse events.

2. High Resistance Barrier: Bemnifosbuvir demonstrated at least ten times greater potency than sofosbuvir against all tested HCV genotypes and showed high resistance to resistance-associated substitutions (RASs).

3. Pharmacokinetics and Safety: Preclinical studies indicated that bemnifosbuvir has favorable absorption, distribution, metabolism, and excretion properties in animal models and was rapidly metabolized to its active form.

4. Low Drug-Drug Interaction Risk: Ruzasvir exhibited a low potential for drug-drug interactions based on in vitro metabolism and transporter interaction studies, making it a suitable option for patients on multiple medications.

In summary, Atea Pharmaceuticals' Phase 2 study on the combination of bemnifosbuvir and ruzasvir for treating HCV is showing highly promising results. The combination therapy not only meets the primary efficacy and safety endpoints but also offers a high barrier to resistance and low risk of drug interactions, making it a strong candidate for addressing the needs of HCV-infected individuals.

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