New data shows favorable profile of bemnifosbuvir for treatment of COVID-19 and hepatitis C, presented at 2023 International Conference on Antiviral Research.- Atea Pharma

Key highlights of the presentations include results from a Phase 1 human absorption, distribution, metabolism, and excretion (ADME) study for bemnifosbuvir demonstrating a favorable ADME profile supportive of the dosing regimen used in SUNRISE-3, a global, multicenter Phase III registrational trial for the treatment of COVID-19.

In vitro metabolism and transporter interaction studies showed bemnifosbuvir has a low risk for interactions with medicines commonly prescribed to patients at risk for COVID-19 progression and for those with HCV infection. In vitro studies also demonstrated advantages of bemnifosbuvir’s mechanism of action, which targets conserved regions of the viruses that cause COVID-19 and HCV infection. These advantages include a higher barrier to resistance and maintenance of antiviral activity in the presence of COVID-19 variants. Additionally, the combination of bemnifosbuvir and ruzasvir for the treatment of HCV demonstrated potent in vitro synergistic antiviral activity and in vivo preclinical safety without adverse interactions

“As COVID-19 becomes endemic, it is essential to have new oral antiviral medicines that are safe, well tolerated and address the current limitations of existing treatments,” said Bruno Canard, Ph.D., lead investigator of the in vitro studies of bemnifosbuvir conducted at Architecture et Fonction des Macromolécules Biologiques, CNRS and Aix-Marseille University. “The data presented at ICAR demonstrate bemnifosbuvir’s unique metabolic activation pathway and how it inhibits enzymes essential to the viral replication of COVID-19 and HCV and its potential to play an important role in the treatment of these serious viral diseases.”

Bemnifosbuvir is an investigational, oral, direct-acting antiviral being evaluated in the Phase III SUNRISE-3 trial for the treatment of COVID-19 in non-hospitalized patients at high risk for disease progression, and in Phase II development for the treatment of HCV in combination with ruzasvir, an oral NS5A inhibitor.

In vitro results demonstrate that bemnifosbuvir is a potent inhibitor of all tested SARS-CoV-2 variants of concern as well as other human coronaviruses such as HCoV-229E, HCoV-OC43, and SARS-CoV-1. Results from an in vitro resistance study conducted with the surrogate virus HCoV-229E in Huh7 cells suggest that bemnifosbuvir may have a high barrier to drug resistance during treatment of COVID-19 and other coronavirus infections.