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.

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