Atea Pharmaceuticals will present the full clinical study at the upcoming EASL Congress in May.
Image Credit: Atea Pharmaceuticals
Atea Pharmaceuticals is going to provide its full phase 2 data, which will show it met its primary endpoints at the upcoming EASL Congress in May. It will present the data in a poster titled, Efficacy and Safety of Bemnifosbuvir and Ruzasvir after 8 Weeks of Treatment in Patients with Chronic Hepatitis C Virus (HCV) Infection.1
“Following our successful phase 2 study and the recent initiation of our global phase 3 program, we look forward to delivering the regimen of bemnifosbuvir and ruzasvir which we believe has the potential to increase the number of HCV patients that are treated and cured,” Atea CEO Jean-Pierre Sommadossi, PhD, said in a statement. “Untreated chronic HCV can have a profound impact on patients’ lives, as well as the associated healthcare and hospitalization costs, as the disease progresses in some cases to liver cancer.”1
Earlier this month, the company announced it had dosed its first patient. It’s C-BEYOND trial will be conducted in the US and Canada, the company is concurrently conducting its C-FORWARD, an international trial. Each trial will enroll approximately 880 treatment-naïve patients, including those with and without compensated cirrhosis.2
The regimen of bemnifosbuvir and ruzasvir will be administered orally once-daily for 8 weeks (in patients without cirrhosis) or 12 weeks (in patients with compensated cirrhosis) while the regimen of sofosbuvir and velpatasvir will be administered orally once-daily for 12 weeks for all patients with or without compensated cirrhosis. 2
The primary endpoint for each trial is HCV RNA < lower limit of quantitation (LLOQ) at 24 weeks from the start of treatment and encompasses sustained virologic response 12 weeks post-treatment (SVR12) in each arm. Measurement at 24 weeks from the start of treatment is to ensure the primary endpoint occurs at the same relative timepoint from the start of treatment in all patients. While C-BEYOND and C-FORWARD are both open-label trials, Atea has put measures and processes in place that are designed to blind Atea personnel to patient treatment assignments. 2
Atea Pharmaceuticals is presenting full Phase 2 data at the EASL Congress 2025, showing that bemnifosbuvir and ruzasvir met their primary endpoints.
The 8-week treatment demonstrated a 97% sustained virologic response (SVR12), supporting its effectiveness for chronic Hepatitis C Virus (HCV), regardless of genotype, age, or fibrosis score.
Two phase 3 trials, C-BEYOND (US & Canada) and C-FORWARD (international), are now enrolling ~880 treatment-naïve patients each.
At last year’s The Liver Meeting, Atea presented a poster that demonstrated the combination therapy achieved a 97% sustained virologic response at 12 weeks post-treatment (SVR12) in a phase 2 lead-in cohort. According to the investigators, the analysis supported a short 8-week treatment with bemnifosbuvir and ruzasvir for chronic HCV.3
The modeling results provided insight on the mechanism of action and demonstrated that the combination of bemnifosbuvir and ruzasvir was highly effective in blocking both viral replication and viral assembly/secretion in HCV-infected patients, independent of genotype, age, sex, or fibrosis score.3
Bemnifosbuvir has been shown in in vitro studies to be approximately 10-fold more active than sofosbuvir (SOF), against a panel of laboratory strains and clinical isolates of HCV GT 1–5. In vitro studies have also demonstrated bemnifosbuvir remained fully active against SOF resistance-associated substitutions (S282T), with up to 58-fold more potency than SOF.2
The pharmacokinetic (PK) profile of bemnifosbuvir supports once-daily dosing for the treatment of HCV. Bemnifosbuvir has been shown to have a low risk for drug-drug interactions. Bemnifosbuvir has been administered to over 2,200 subjects and has been well-tolerated at doses up to 550 mg for durations up to 12 weeks in healthy subjects and patients.2
The other half of the combination, ruzasvir, has demonstrated highly potent and pan-genotypic antiviral activity in preclinical (picomolar range) and clinical studies. Ruzasvir has been administered to over 1,500 HCV-infected patients at daily doses of up to 180 mg for 12 weeks and has demonstrated a favorable safety profile. The PK profile of ruzasvir supports once-daily dosing.2
