Novartis to seek FDA Emergency Use Approval approval for new COVID-19 therapy
pharmafile | January 11, 2022 | News story | Manufacturing and Production |
Novartis shared on the 10 January, that positive data from a clinical trial of COVID-19 therapeutic drug ensovibep, has prompted the firm to exercise an option to in-license the antiviral from development partner Molecular Partners, and later seek emergency use approval from US regulators.
Ensovibep is a multi-specific DARPin (Designed Ankyrin Repeat Protein) antiviral therapeutic candidate, specifically designed to block the receptor binding domains for SARS-CoV-2 spike protein through highly potent and cooperative binding. This makes the therapy particularly challenging for escape mutants.
Topline results from the randomised EMPATHY Part A study in acute COVID-19 ambulatory (non-hospitalised) patients comparing single intravenous doses of ensovibep, with a placebo, met the primary endpoint of viral load reduction over eight days. EMPATHY Part A enrolled 407 patients to identify a dose of ensovibep with optimal safety and efficacy. The trial recruited patients in the US, South Africa, India, the Netherlands and Hungary, to explore three doses: 75mg, 225 mg, and 600mg.
“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.”
“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. “We are incredibly excited about the opportunity to provide a potential therapeutic option for patients around the world who require access to effective COVID-19 treatments.”
Ana Ovey
