The pharmaceutical firm and collaborator Molecular Partners reported positive topline data out of their Phase II study for ensovibep, an antiviral candidate for treating the virus. 2022
Pharmaceutical firms Novartis and Molecular Partners—who have been working together to study the viability of single-use intravenous dosing of ensovibep (MP0420) in treating acute, ambulatory COVID-19 patients—have reported positive data resulting from their EMPATHY Phase II study of the drug. Ensovibep is a multi-specific designed ankyrin repeat protein (DARPin), designed to block the receptor-binding domains of SARS-CoV-2 spike protein through potent and cooperative binding, making it challenging for escape mutants.
“We are pleased that the results from the EMPATHY trial demonstrate the positive therapeutic effect of ensovibep, with the potential to be an important new treatment option to combat the rapidly evolving SARS-CoV-2 pandemic,” said Vas Narasimhan, CEO of Novartis. “As COVID-19 continues to burden healthcare systems across the globe, a range of treatments will be needed, and Novartis is proud to continue our collaboration with Molecular Partners on this unique treatment for COVID-19 and contribute ensovibep to this suite of options.”
According to the collaborators, the antiviral (tested against placebo) met the primary endpoint of viral-load reduction over eight days. The secondary endpoint (involving hospitalization or emergency-room visits related to COVID-19, or death) showed an overall reduction in risk of events at 78% across ensovibep arms, weighed against placebo; reportedly no deaths occurred in any patient treated with the antiviral.
“These encouraging results come at a time when the need for therapies with pan-variant activity, such as ensovibep, has never been greater,” said Patrick Amstutz, CEO of Molecular Partners. “Today’s data are a culmination of a persistent team effort, between ourselves and Novartis, to deliver a tailored antiviral with demonstrated safety and efficacy in global clinical trials. As pioneers of DARPin therapeutics, our team has the unique ability to rapidly generate and develop multi-specific DARPin therapeutics. We look forward to continue to demonstrate our capabilities and the potential of our pipeline in oncology, virology, and for patients in need.”
According to the terms of their agreement, Novartis will become responsible for the development, manufacturing, distribution, and commercialization activities of ensovibep. Novartis reportedly has commenced scale-up activities in its large-scale biologics production facilities.