Atea Pharmaceuticals Shares Promising Data From Therapy Study For Hepatitis C Virus

Zinger Key Points
  • The combination regimen was well tolerated, with no drug-related severe adverse events (SAEs) or treatment discontinuations.
  • The company says the Phase 2 study continues to enroll up to an additional 220 subjects, including those with compensated cirrhosis.

Atea Pharmaceuticals Inc AVIR announced Wednesday new data from the lead-in cohort (n=60) of the company’s ongoing Phase 2 combination study of bemnifosbuvir for hepatitis C virus (HCV).

With an eight-week treatment duration in 60 patients, the Phase 2 data from the lead-in cohort of non-cirrhotic patients showed a 97% sustained virologic response rate at 12 weeks post-treatment (SVR12), the study’s primary efficacy endpoint.

The company will also present preclinical data further demonstrating a high barrier to resistance and pharmacokinetics for bemnifosbuvir and a low risk of drug-drug interactions for ruzasvir.

The combination was generally safe and well tolerated. There were no drug-related serious adverse events or treatment discontinuations, and adverse events were mostly mild.

These data will be presented at the European Association for the Study of the Liver (EASL) Congress.

Results from the lead-in cohort of 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 (SAEs) or treatment discontinuations.

The company says the Phase 2 study continues to enroll up to an additional 220 subjects, including those with compensated cirrhosis.

The company said that the results also demonstrated that bemnifosbuvir is at least ten-fold more potent than sofosbuvir, a medication to treat HCV infections, across all genotypes tested and is not resistant to resistance-associated substitutions (RASs) that have been found to alter the activity of sofosbuvir.

Following a single oral dose in rats, bemnifosbuvir has favorable overall absorption, distribution, metabolism, and excretion (ADME) properties, including good bioavailability (>60%) and wide distribution to tissues with low penetration into the brain.

Price Action: AVIR shares are up 2.12% at $3.85 at last check Wednesday.

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