Atea plans Phase 3 for hepatitis C combo after mid-stage success

Atea Pharmaceuticals made a significant announcement on Wednesday regarding the results from a mid-stage clinical trial of its hepatitis C treatment combination. The study focused on a regimen combining bemnifosbuvir, a polymerase inhibitor, and ruzasvir, an NS5A inhibitor. The trial, which included 275 participants, successfully met both its primary safety and efficacy endpoints.

Patients who adhered to the eight-week treatment regimen achieved a sustained virologic response rate of 98% twelve weeks post-treatment. Additionally, participants with liver cirrhosis who were consistent with their treatment experienced an 88% response rate within the same timeframe.

In terms of safety, the trial reported no serious adverse events related to the drugs, and there were no discontinuations due to safety concerns. Atea Pharmaceuticals plans to present the full dataset at an upcoming medical conference.

Jean-Pierre Sommadossi, the founder and CEO of Atea Pharmaceuticals, expressed the company's enthusiasm for discussing the trial outcomes with regulatory authorities, including the FDA. The goal is to move forward to Phase 3 development early next year.

For the forthcoming Phase 3 trial, Atea Pharmaceuticals intends to simplify the treatment regimen by reducing the dosage from four tablets a day to two, aiming to improve patient convenience. The Phase 2 data confirmed that an eight-week treatment period is effective, although patients with liver cirrhosis will continue to receive the combination therapy for twelve weeks.

In a related development, Atea Pharmaceuticals previously reported in September that bemnifosbuvir did not succeed in a Phase 3 trial for treating Covid-19, leading to the discontinuation of that particular study.