The first patient was dosed for this open-label trial.
Yesterday, Atea Pharmaceuticals announced it has begun its phase 2 study for it investigational antiviral, bemnifosbuvir (BEM, AT-527), in combination with ruzasvir for the treatment of hepatitis C virus (HCV). The open label phase 2 study offers the opportunity to improve standard of care for those with HCV, with potential for a short duration, protease inhibitor-free treatment.
“The initiation of this phase 2 combination study marks an important clinical milestone for Atea,” CEO and Founder of Atea Pharmaceuticals Jean-Pierre Sommadossi, PhD, said in a statement. “We believe the combination of bemnifosbuvir and ruzasvir has the potential to significantly improve upon the current standard of care by offering a short duration, pan-genotypic, protease inhibitor-free treatment for patients with HCV, with or without cirrhosis.”
According to the company, the study is designed to enroll approximately 280 HCV-infected, direct-acting antiviral naive patients across all genotypes, including a 60 patient lead-in cohort. Patients will be administered 550 mg bemnifosbuvir in combination with 180 mg ruzasvir once-daily for eight weeks.
The primary endpoints of the study are safety and sustained virologic response (SVR) at week 12 post-treatment. Other virologic endpoints include virologic failure, SVR at Week 24 post-treatment and resistance. Preliminary data from the 60 patient lead-in cohort are anticipated in the fourth quarter of 2023.
In a previous interview with Contagion, Atea said the combination of bemnifosbuvir and ruzasvir demonstrated potent in vitro synergistic antiviral activity and in vivo preclinical safety without adverse interactions.
Preliminary data from the lead-in cohort is expected in the fourth quarter of 2023.