Novartis will license a new drug it has been developing with Molecular Partners to treat COVID-19 after getting positive trial data, the companies announced this week.
The two companies reported on Monday they had received positive topline data from a phase 2 study for ensovibep (mp0420), an antiviral therapeutic for COVID-19 that will from now on be developed and manufactured by Novartis.
“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,” Narashimhan said.
The DARPin (Designed Ankyrin Repeat Protein) antiviral therapeutic candidate met the primary endpoint of viral load reduction over eight days in a study in acute COVID-19 ambulatory patients comparing single intravenous doses of ensovibep versus placebo, the two companies said in a statement.
As the SARS-CoV-2 virus evolves, a multi-solution strategy is needed to combat the pandemic and there will be a need for antiviral treatments to complement the global vaccination efforts, the companies said. Despite availability of vaccinations, there continues to be disease transmission, either through pockets of unvaccinated populations, in patients with compromised immune systems and comorbidities, or through emerging variants, and breakthrough infections are likely to continue.
A recent in vitro analysis3 also showed that ensovibep maintains full neutralization of the pseudoviruses containing the mutations identical to the omicron variant of COVID-19, the companies said.
“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.”
Novartis said it will exercise its option to in-license ensovibep from Molecular Partners and then seek expedited regulatory authorizations globally – first via the FDA’s Emergency Use Authorization (EUA).
Upon completion of in-licensing, Molecular Partners will receive a milestone payment of CHF150 million (about $164 million USD) and will be entitled to a 22% royalty on sales of ensovibep in commercial territories. Novartis will become responsible for the development, manufacturing, distribution and commercialization activities of ensovibep.