Viral disease-focused biotech Atea Pharmaceuticals announced a late-stage trial failure for its nucleotide polymerase inhibitor, which it was investigating as a Covid-19 treatment.
The Phase 3 SUNRISE-3 trial didn’t hit the primary endpoint of a statistically significant reduction in all-cause hospitalization or death through 29 days in 2,221 high-risk patients with mild to moderate Covid-19.
Atea added that it wouldn’t try and get the drug, an oral treatment called bemnifosbuvir, cleared by regulators.
“Variants of Covid-19 are constantly evolving and the natural history of the disease trended toward milder disease, which has resulted in fewer hospitalizations and death,” Atea CEO and founder Jean-Pierre Sommadossi wrote in a statement.
“In particular, hospitalization due to severe respiratory disease caused by Covid was not observed in SUNRISE-3, in contrast to our prior study,” Sommadossi added. “In an environment where there is much less Covid-19 pneumonia, it becomes more difficult for a direct-acting antiviral to demonstrate impact on the course of the disease.”
Despite the failure as a monotherapy, bemnifosbuvir is still in a Phase 2 trial in combination with ruzasvir for the treatment of hepatitis C. More data are expected in the fourth quarter after initial positive results were released earlier this year.