Global Phase 3 trial of Atea’s combo therapy doses 1st hep C patient
Ongoing trials to enroll hundreds of patients in North America and globally
The first participant has been dosed in a Phase 3 clinical trial testing Atea Pharmaceuticals’ combination therapy of bemnifosbuvir and ruzasvir in people with chronic hepatitis C.
Called C-FORWARD (NCT07037277), the global study is enrolling up to 880 adults with a chronic infection of the hepatitis C virus (HCV) who have not previously received any antiviral treatment for hepatitis C. Participants are being recruited at a single site in Moldova, with additional sites expected to open in countries outside of North America.
The trial runs in parallel with the North American Phase 3 C-BEYOND trial (NCT06868264), which has already dosed its first patient in the U.S., where enrollment is ongoing. The study is expected to expand to sites in Canada.
Trials to compare Atea’s combination therapy against Epclusa
Both trials will compare the safety and efficacy of Atea’s once-daily, fixed-dose combination therapy against Epclusa (sofosbuvir/velpatasvir), an approved oral treatment for hepatitis C.
“We are pleased to reach another important milestone for our global HCV program with the first patient dosed in C-FORWARD, our HCV Phase 3 trial being conducted outside North America,” Jean-Pierre Sommadossi, PhD, Atea’s CEO and founder, said in a company press release. “Our Phase 3 program is now enrolling patients on a global basis.”
Last month, Atea hosted a web panel with global hepatitis C experts to discuss Phase 2 results and the company’s Phase 3 plans. The virtual panel can be replayed upon registration.
“We are focused on the successful development of a potential best-in-class HCV regimen that may make it easier to treat and cure patients infected with HCV,” Sommadossi said.
Hepatitis C is a liver disease caused by infection with the HCV, leading to inflammation, or hepatitis. While the infection can sometimes resolve on its own, in most cases it becomes chronic, potentially progressing to serious liver complications, including irreversible scarring (cirrhosis), liver failure, and cancer, if left untreated.
“The evolving HCV patient population and rising burden of untreated HCV in Europe mirrors trends seen in North America. Many patients present with [simultaneous health conditions] and complex medical histories, with treatment decisions often influenced by [other] medications,” said Tarik Asselah, MD, PhD, C-FORWARD’s principal investigator and professor of hepatology at University of Paris-Cité’s Hôpital Beaujon. “To truly advance HCV eradication and meet the needs of today’s patients, an ideal treatment would combine high efficacy, short duration, and minimal risk of drug-drug interactions.”
Bemnifosbuvir and ruzasvir, like approved treatments for hepatitis C, work by disrupting the virus’s ability to grow and replicate in liver cells. The novel combination, however, seeks to clear the virus more quickly, potentially enabling a shorter course of treatment.
Positive results from earlier trials
Results from an earlier Phase 2 study (NCT05904470) showed 98% of participants had no detectable HCV following bemnifosbuvir plus ruzasvir treatment. Among a subset of patients (17%) with suboptimal adherence to the treatment, the rate of sustained virologic response at 12 weeks, which is defined as having an undetectable HCV load in the blood 12 weeks after completing treatment, was still 95%.
According to Atea, additional Phase 1 trials showed a low risk of drug-drug interactions and confirmed the combo’s safety in hepatitis C patients co-infected with HIV, a common occurrence due to shared routes of transmission. Bemnifosbuvir was also found to be safe in people with impaired liver or kidney function, with no need for dose adjustment.
In both C-FORWARD and C-BEYOND, participants are randomly assigned to receive the investigational combination or Epclusa once-daily.
Patients who do not have cirrhosis will receive bemnifosbuvir plus ruzasvir for eight weeks (about two months), while those with compensated cirrhosis (when the liver can still work properly) will be treated for 12 weeks (about three months). In the Epclusa group, all participants, regardless of cirrhosis, will receive 12 weeks of treatment.
The main goal of both trials is to evaluate the proportion of patients achieving sustained virologic response at 12 weeks.
“The regimen of bemnifosbuvir and ruzasvir may offer a potent and more convenient option for my patients and may also make treatment more accessible for any patient who tests positive for HCV,” said Eric Lawitz, MD, medical director at the Texas Liver Institute and clinical professor of medicine at the University of Texas Health San Antonio. “I look forward to seeing the Phase 3 results when they are available.”
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