Novartis and Molecular say DARPin antiviral therapeutic for COVID-19 trial meets goals

Pharma giant Novartis (NOVN: VX) and Swiss clinical-stage biotech Molecular Partners (SIX: MOLN) today announced that Part A of the EMPATHY clinical trial that compared single intravenous doses of ensovibep, a DARPin antiviral therapeutic candidate versus placebo to treat COVID-19, met the primary endpoint of viral load reduction over eight days.

The two secondary endpoints also showed clinically meaningful benefit over placebo – (1) composite endpoint of hospitalization and/or Emergency Room (ER) visits or death, and (2) time to sustained clinical recovery. Novartis confirms it will now exercise its option to in-license ensovibep from Molecular Partners and, following exercise of the option, will seek expedited access globally, first via the Food and Drug Administration’s emergency use authorization (EUA) process. The news sent Molecular’s shares nearly 30% to 20.30 Swiss francs.

The companies first entered a collaboration on Molecular’s proprietary DARPin technologies in 2020, which involved an upfront payment to the latter of around $66 million. Last month Novartis also acquired a license to develop, manufacture and commercialize DARPin-conjugated radioligand therapies (DARPin-RLTs).