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

Dive Brief:

• Atea Pharmaceuticals said Wednesday that its experimental combination regimen to treat the hepatitis C virus succeeded in a Phase 2 trial, clearing the way for Phase 3 research to begin early next year.
• In the Phase 2 study, patients received a combination of bemnifosbuvir and ruzasvir for eight weeks, without any reports of serious side effects or treatment discontinuations. Twelve weeks later, researchers measured the effects the drugs had in fighting hepatitis C.
• Overall, 98% of patients who adhered to the treatment regimen had a sustained virologic response at the 12-week checkpoint. That rate went up to 99% among patients who weren’t suffering from cirrhosis. And Atea said the drugs showed success even among patients who didn’t take all the pills as directed, suggesting a “robust potency” for the treatment.

Dive Insight:

Atea is hoping to carve a niche in the multibillion dollar market for hepatitis C drugs by positioning its product as a more convenient option for patients, offering a short duration of treatment with no food effect. In the Phase 3 study, the company also plans to reduce the daily pill count to two from four.

In slides prepared for investors, Atea noted how the population of hepatitis C patients has changed, shifting to a younger population between 20 and 49 years old that is less likely to have progressed to cirrhosis. Meanwhile, the people at the highest risk for the virus — such as those with substance abuse disorders — are also the ones most likely to have trouble adhering to a complicated treatment regimen.

“We believe that this regimen has the potential to play a major role in the eradication of HCV in the U.S.,” Atea CEO Jean-Pierre Sommadossi said in the company’s press release.

Atea needs a win. The company was once a high flier in the industry, inking a $350 million development deal with Roche for a COVID-19 treatment and pulling off a successful initial public offering in 2020. But disappointing study results tanked Atea’s stock and led Roche to withdraw from their COVID-19 partnership. Atea’s shares, which had topped $86 in early 2021, traded around $3.20 early Wednesday.

Through the ups and downs, the company’s management has defended the value of its pipeline. Atea’s board of directors last year unanimously rejected an unsolicited bid from Tang Capital Partners, saying it fundamentally undervalued the company. Under that offer, Atea stockholders would have received $5.75 a share, plus potential proceeds on future licenses or revenue from research.

This article was originally published here.