Novartis and Molecular Partners announced the start of the clinical trial EMPATHY, a Phase 2 and 3 study, to explore the use of its novel DARPin® therapeutic candidate ensovibep (MP0420) for the treatment of COVID-19.
The EMPATHY clinical trial 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. At that point Phase 3 will move ahead with an additional 1,700 patients with results anticipated in H1 2022. If the initial EMPATHY trial results are convincing, this would pave the way for Novartis to seek expedited approval via the FDA’s Emergency Use Authorization (EUA).
“By virtue of its tri-specific design, ensovibep was built to resist viral mutations and indeed shows potent inhibition of all variants of concern to date, with the potential to maintain activity also for future variants. This type of broad-spectrum activity is essential for any treatment of relevance for patients with COVID-19,” said Patrick Amstutz, Chief Executive Officer, Molecular Partners. “Reaching this important clinical milestone is not only a key step to combat this virus, but also validating our DARPin approach to generate multispecific antiviral therapies in the fight against global pandemics.”
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