NVS - Novartis Molecular Partners launches EMPATHY trial for ensovibep in COVID-19

Novartis (NVS) and Molecular Partners (MLLCF) have started the clinical trial EMPATHY, a Phase 2 and 3 study, to explore the use of novel DARPin therapeutic candidate ensovibep (MP0420) for the treatment of COVID-19.The EMPATHY trial is investigating the safety and efficacy of ensovibep in early COVID-19, to prevent worsening symptoms and hospitalization.The study plans to enroll 2100 patients, with 400 patients to be enrolled into Phase 2, followed by 1700 patients in Phase 3, over the age of 18, with a positive SARS-CoV-2 antigen test and who are experiencing at least two pre-determined mild/moderate symptoms of COVID-19 within 7 days of their diagnosis.Initial results from Phase 2 are anticipated in August 2021 whereas data from Phase 3 study are expected in H1 2022.Novartis might seek expedited approval via the FDA’s Emergency Use Authorization ((EUA)) if results are convincing.Earlier in March, Novartis reported positive early-stage results for ensovibep in COVID-19.

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Novartis, Molecular Partners launches EMPATHY trial for ensovibep in COVID-19