Atea Pharmaceuticals Doses First Patient In Phase 3 Trial For Chronic Hepatitis C Treatment

(RTTNews) - Atea Pharmaceuticals (AVIR) on Wednesday announced the dosing of the first patient in its C-BEYOND phase 3 trial in the US and Canada.

The trial will evaluate the combination of bemnifosbuvir and ruzasvir for treating chronic hepatitis C virus - HCV in adults, comparing it to the standard regimen of sofosbuvir and velpatasvir. Atea's CEO, Jean-Pierre Sommadossi, expressed that this milestone marks significant progress toward delivering a next-generation HCV therapy.

In addition to C-BEYOND, Atea is conducting the international C-FORWARD trial, both enrolling about 880 treatment-naïve patients, including those with and without compensated cirrhosis. The bemnifosbuvir and ruzasvir regimen will be administered once daily for 8 weeks (for patients without cirrhosis) or 12 weeks (for those with compensated cirrhosis), while the sofosbuvir and velpatasvir combination will be administered for 12 weeks for all patients. The primary endpoint of both trials is achieving an HCV RNA level below the lower limit of quantitation (LLOQ) at 24 weeks, measuring sustained virologic response (SVR12).

Atea previously presented phase 2 data showing that the bemnifosbuvir and ruzasvir combination achieved a 97% SVR12 in a lead-in cohort, supporting the potential for a short, 8-week treatment for chronic HCV. The combination was found to effectively block viral replication and assembly/secretion, regardless of factors like genotype, age, sex, or fibrosis score.

Bemnifosbuvir has shown to be significantly more potent than sofosbuvir in vitro, with a 10-fold higher activity against various HCV genotypes and better resistance to common sofosbuvir-associated mutations. It also has a favorable pharmacokinetic profile that supports once-daily dosing and low risk for drug interactions. Ruzasvir, the second component of the combination, has demonstrated potent, pan-genotypic antiviral activity and has been well-tolerated in over 1,500 patients. Its pharmacokinetics also support once-daily dosing.

Sommadossi emphasized that if successful, their regimen could offer key advantages like a short treatment duration, low drug-drug interaction risk, and patient convenience, with the potential to improve outcomes and expand treatment access.

Wednesday, AVIR closed at $2.74, up 3.40%, and is currently trading flat in after-hours on the Nasdaq Global Select Market.