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

Novartis AG NVS along with Molecular Partners AG 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.