Benzinga | May 27, 2021 08:19AM EDT

Novartis, Molecular Partners Initiate Global Trial For COVID-19 Treatment

* Novartis AG (NYSE:NVS) along with Molecular Partners AG (OTC: MLLCF) is kicking off a Phase 2/3 EMPATHY study of DARPin therapeutic candidate, ensovibep (MP0420), to treat COVID-19.

* The program is investigating the safety and efficacy of ensovibep in patients with COVID-19, who are in the early stages of infection, to prevent worsening symptoms and hospitalization. The study will enroll 400 patients in Phase 2 to identify a dose with optimal safety and activity, with initial results anticipated in August 2021.

* Then Phase 3 will move ahead with an additional 1,700 patients with results anticipated in H1 2022.

* Pending the positive outcome, it would pave the way for Novartis to seek expedited approval via the FDA's Emergency Use Authorization (EUA).

* Initial findings from the Phase 1 trial of ensovibep found it safe and well-tolerated with no significant adverse events. Predictable exposure was seen post-administration, confirming the expected half-life of two to three weeks.

* Novartis paid $69 million in October 2020 to collaborate with Molecular Partners on ensovibep and MP0423.

* The preclinical work for MP0423 is still ongoing and led by Molecular Partners.

* Price Action: NVS shares closed at $89.16 on Wednesday.