Reduced hospitalizations for COVID-19 patients with use of bemnifosbuvir shown at 2023 European Congress of Clinical Microbiology & Infectious Diseases

MORNINGSKY results showed that both vaccinated and unvaccinated patients with low and high risk for COVID-19 disease progression experienced a 71% relative reduction in risk of hospitalization with bemnifosbuvir (n=137) versus placebo (n=70). In an exploratory analysis of high-risk patients (greater than 40 years old; median age was 41 years old), there was an 82% relative risk reduction. Bemnifosbuvir was generally well tolerated.

MORNINGSKY was a randomized, double-blind, multi-center, placebo-controlled Phase III trial evaluating the efficacy, safety, antiviral activity, and pharmacokinetics of bemnifosbuvir in patients with mild to moderate COVID-19 randomized 2:1 to receive bemnifosbuvir 550 mg twice-daily or placebo in an outpatient setting. The primary endpoint of time to symptom alleviation was not met, however, a key secondary clinical efficacy endpoint showed a meaningful relative risk reduction in hospitalization and additional secondary clinical efficacy endpoints showed lower rates of COVID-19-related complications, medically attended visits, and post treatment infections compared with placebo. No clear differences in any of the virology endpoints between the bemnifosbuvir and placebo arms were observed. There were no deaths in the trial. As announced in December 2021, MORNINGSKY was closed out early, having enrolled 216 patients of which 207 patients were evaluable for efficacy. Bemnifosbuvir is currently being evaluated in the global Phase III SUNRISE-3 registrational trial (NCT05629962).