Novartis (NVS) and Molecular Partners said that it will start the clinical trial EMPATHY, a Phase II and III study, to explore the use of its DARPin therapeutic candidate ensovibep (MP0420) for the treatment of COVID-19.
Novartis will conduct the clinical trial program for ensovibep, with Molecular Partners as sponsor of the studies. In March 2021, Molecular Partners reported positive initial Phase 1 results in healthy volunteers.
The companies plans to enroll 2100 patients in the study. Of which 400 patients will be enrolled in phase II study to identify a dose with optimal safety and activity, with initial results anticipated in August 2021.
Additional 1700 patients will be enrolled in phase III, with results anticipated in the first-half of 2022.
Those eligible for the EMPATHY trial are adults, 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.
Novartis has been granted an option from Molecular Partners to in-license global rights of ensovibep and MP0423 - DARPin antiviral therapeutic candidates that are undergoing testing to target SARS-CoV-2 spike protein.
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