Atea plans Phase 3 study for hepatitis C drug following mid-stage results

Atea Pharmaceuticals announced on Wednesday that its experimental combination treatment for hepatitis C showed promising results in a Phase 2 trial, paving the way for Phase 3 studies to start early next year. During the Phase 2 trial, participants were administered a combination of bemnifosbuvir and ruzasvir for eight weeks. Notably, no serious side effects were reported, and there were no treatment discontinuations.

Twelve weeks after the treatment concluded, the researchers assessed the efficacy of the medication in combating hepatitis C. The results were encouraging: 98% of patients adhering to the treatment had a sustained virologic response at the 12-week mark. Among patients without cirrhosis, this response rate increased to 99%. Furthermore, Atea highlighted that the drugs demonstrated significant efficacy even among those patients who did not follow the pill regimen precisely, indicating a strong potential of the treatment.

Atea aims to establish itself in the lucrative market for hepatitis C medications by offering a more convenient treatment option for patients. The company’s approach focuses on a shorter duration of treatment with no dietary restrictions. In the upcoming Phase 3 trial, Atea plans to reduce the number of daily pills from four to two, further enhancing the convenience for patients.

Atea has also pointed out demographic shifts in the hepatitis C patient population, noting that it now includes a younger demographic, aged 20 to 49, who are less likely to have advanced to cirrhosis. Additionally, those at the highest risk for the virus, such as individuals with substance abuse issues, are typically the ones facing challenges in adhering to complex treatment regimens. Atea CEO Jean-Pierre Sommadossi expressed optimism about the treatment's potential impact, stating that this regimen could play a significant role in eliminating hepatitis C in the United States.

The company is in need of a significant breakthrough. Atea previously enjoyed a strong position in the industry, securing a $350 million development deal with Roche for a COVID-19 treatment and successfully going public in 2020. However, subsequent disappointing study results negatively impacted Atea's stock, causing Roche to withdraw from their partnership on the COVID-19 treatment. By early Wednesday, Atea’s shares were trading around $3.20, a sharp decline from their peak of over $86 in early 2021.

Despite these setbacks, Atea’s management has consistently defended the potential of its drug pipeline. Last year, Atea's board of directors unanimously rejected an unsolicited acquisition offer from Tang Capital Partners, arguing that the proposal significantly undervalued the company. Under this offer, Atea shareholders would have received $5.75 per share, along with potential future proceeds from licenses or research-related revenue.

As Atea prepares for the next phase of its hepatitis C treatment research, the company remains focused on demonstrating the value and efficacy of its pharmaceutical developments to both the market and potential patients.