Novartis Seeks COVID-19 Antiviral Candidate Authorization

Switzerland-based Molecular Partners AG today announced its partner Novartis had requested Emergency Use Authorization from the U.S. FDA for ensovibep, a DARPin antiviral therapeutic candidate to treat COVID-19.

Ensovibep is explicitly designed to inhibit target cell entry of the SARS-CoV-2 beta coronavirus.

This FDA submission is based on the totality of clinical and preclinical studies data, including the positive results of the Phase 2 portion of the EMPATHY study. This randomized, placebo-controlled study enrolled 407 symptomatic patients infected with SARS-CoV-2.

DARPins (Designed Ankyrin Repeat Proteins) are mono or multi-specific protein-based therapies designed to engage their targets for various effects specifically.

Ensovibep includes three covalently linked individual DARPin domains that bind to the spike protein of SARS-CoV-2.

With these domains incorporated into a single molecule, ensovibep is designed to block the receptor-binding domain of the SARS-CoV-2 spike protein, even in the presence of some mutations of the spike protein.

Several characteristics of DARPin therapeutics make them potentially suitable for COVID-19 treatment, including multi-specific binding, the rapid onset of action, and scalable bacterial production.

"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," commented Vas Narasimhan, CEO of Novartis, in a press release issued on January 10, 2022.

"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." 

Molecular Partners and Novartis entered into a license agreement on January 18, 2022, under which Novartis in-licensed global rights to ensovibep.

For further details regarding today's announcement, please contact Seth Lewis [email protected].