Bemnifosbuvir-ruzasvir Phase 3 trials in hepatitis C launch in April
Each trial recruiting 800 people with chronic hepatitis C
Atea Pharmaceuticals plans to launch two parallel Phase 3 trials soon to test its investigational combination therapy of bemnifosbuvir and ruzasvir for people with hepatitis C.
One trial will take place at sites in the U.S. and Canada, while the other will enroll hepatitis C patients at sites outside of North America. Both studies will test the combination therapy against the approved hepatitis C treatment Epclusa (sofosbuvir/velpatasvir). Recruitment is expected to start in April.
This comes after positive feedback from a meeting in January with the U.S. Food and Drug Administration (FDA), where promising data from a Phase 2 clinical trial (NCT05904470) were discussed.
“I am pleased to share that we recently had a successful End-of-Phase 2 meeting with the FDA, and we expect enrollment to begin next month in our global [hepatitis C] Phase 3 program evaluating the regimen of bemnifosbuvir and ruzasvir,” Jean-Pierre Sommadossi, PhD, CEO and founder of Atea, said in a company press release.
Hepatitis C is a condition marked by liver inflammation, or hepatitis, due to a hepatitis C virus (HCV) infection. Chronic infection can eventually lead to serious liver problems such as irreversible scarring (cirrhosis), failure, and cancer of the liver.
Combo expected to work faster than currently approved treatments
Similar to standard hepatitis C antiviral treatment, bemnifosbuvir and ruzasvir work by blocking the HCV’s ability to grow and replicate inside liver cells. According to Atea, the novel combination is expected to work faster than currently approved treatments, allowing more convenience for patients.
A previous Phase 2 trial tested the combo in 275 people with chronic HCV infection who had never been treated with antivirals.
Top-line data showed 98% of patients who took bemnifosbuvir and ruzasvir as directed for eight weeks achieved sustained virologic response at 12 weeks post-treatment (SVR12). This measure is defined as reaching an HCV load in the blood below the lower limit of detection that’s sustained for 12 weeks (about three months) after treatment completion.
The treatment combo was also found to be generally safe and well tolerated.
“Results to-date demonstrate the potency of our potential best-in-class regimen with a short 8-week treatment duration, low risk of drug-drug interactions and convenience with no food effect,” Sommadossi said.
Atea expects to present full Phase 2 trial data at a future scientific meeting.
The upcoming Phase 3 trials will each enroll up to 800 people with chronic hepatitis C who either don’t have cirrhosis or have compensated cirrhosis, meaning the liver is still able to function despite irreversible liver scarring.
Phase 3 trial participants will receive bemnifosbuvir-ruzasvir or Epclusa
Participants without cirrhosis will get bemnifosbuvir plus ruzasvir for eight weeks or Epclusa for 12 weeks, while those with compensated cirrhosis will be given the experimental combo or Epclusa for 12 weeks.
The main goals are to assess SVR12 and the number of patients with no detectable HCV genetic material at 24 weeks (about six months) after starting treatment.
The studies will be open-label, meaning participants will know whether they are receiving the bemnifosbuvir-ruzasvir combo or Epclusa. The open-label design was chosen due to the fact that treatment length and packaging differs between the two therapies, making it nearly impossible to stop patients from knowing which they were getting.
However, even though patients and investigators will know which therapy is being given, Atea will be blinded so the company will not know which treatment group is which when analyzing the data to minimize the chances for bias.
“Globally, the burden of untreated HCV infection is significant, with approximately 50 million people living with the disease, including up to 4 million in the U.S.,” Sommadossi said. “We believe our regimen, if approved, has the potential to play a major role in the eradication of HCV in the US and to disrupt and expand the global HCV market.”
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