At the European Association of the Study of the Liver (EASL) Congress in June 2024, Atea presented clinical
data from the lead-in cohort (n=60) of the ongoing Phase 2 study. With an 8-week treatment duration, data from the lead-in cohort
of non-cirrhotic patients showed a 97% SVR12 rate in efficacy evaluable patients. Two subjects (GT1b and GT2b) experienced post-treatment relapse or failure. Each of these patients had low plasma drug levels
and similar viral mutations at both the baseline and 12-weeks post-treatment timepoint, which indicated that the relapse or failure was due to treatment non-adherence
rather than viral resistance. These results also showed a 100% SVR12 rate in participants infected with genotype 3 (n=13), a historically difficult-to-treat genotype of
HCV. In the lead-in cohort, the combination regimen was well tolerated, with no drug-related serious adverse events or treatment discontinuations.
Data also presented at EASL included additional preclinical data further demonstrating a high barrier to resistance and favorable pharmacokinetics (PK) for
bemnifosbuvir and a low risk of drug-drug interactions for ruzasvir. Atea has previously reported a low risk of drug-drug interactions for bemnifosbuvir.
Atea is currently planning for an End of Phase 2 meeting with the US Food and Drug Administration early in the first quarter of 2025 to support the initiation
of the Phase 3 program.
Atea has selected and is manufacturing a fixed dose combination (FDC) tablet for its upcoming Phase 3 program. The FDC tablet
reduces the daily pill count from four to two tablets, enhancing patient convenience, with no food effect demonstrated in recent studies.
New Data
Presentations at Upcoming Scientific Meetings
At The Liver Meeting 2024, being held from November 15-19,
2024, three posters supportive of the combination of bemnifosbuvir and ruzasvir as a potential treatment for HCV will be presented. The posters detail additional safety and resistance data for bemnifosbuvir and present multiscale modeling data
estimating the effectiveness of the combination of bemnifosbuvir and ruzasvir in blocking HCV replication and viral assembly and secretion.
At the
American College of Pharmacometrics meeting, being held on November 11, 2024, supportive data from an integrated population PK model that was developed to simultaneously characterize the PK profile of bemnifosbuvir and its metabolites will be
presented.
COVID-19
Phase 3 SUNRISE-3 Trial: In September 2024, Atea announced results from the Phase 3 SUNRISE-3 trial, a global, multicenter, randomized, double-blind, placebo-controlled study evaluating bemnifosbuvir in patients with mild to moderate COVID-19. The trial did not meet its primary endpoint of a statistically significant reduction in all-cause hospitalization or death through Day 29. Total enrollment for the
monotherapy cohort consisted of 2,221 high-risk patients randomized 1:1 to receive bemnifosbuvir 550 mg twice-daily (BID) or placebo BID for five days. In the trial, bemnifosbuvir was shown to be generally safe and well tolerated.
The evolving nature of COVID-19, including milder disease presentations and a reduction in hospitalizations due to COVID-19 related severe respiratory disease, pose significant challenges in demonstrating a clinical impact with a direct-acting antiviral such as bemnifosbuvir. Given the trial results and the changing landscape of
the pandemic, Atea will not pursue a regulatory pathway forward for bemnifosbuvir for COVID-19.
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