NVS Novartis AG

By Chris Wack

Molecular Partners AG shares rose 37% to $22.60 in premarket trading after the company and Novartis said that Part A of their clinical trial comparing 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 company said the two secondary endpoints in the study also showed clinically meaningful benefit over placebo: composite endpoint of hospitalization and/or Emergency Room visits or death, and time to sustained clinical recovery.

Novartis said it will 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 EUA process.

The clinical trial, which is being conducted by Novartis, with Molecular Partners as sponsor, is a placebo controlled study in ambulatory adult patients with Covid-19. Part A enrolled 407 patients to identify a dose of ensovibep with optimal safety and efficacy and recruited patients in the U.S., South Africa, India, the Netherlands, and Hungary to explore three doses: 75mg, 225mg and 600mg.

Results from the study showed that the primary endpoint was met with a statistically significant reduction in viral load over eight days, compared to placebo, for all three dosing arms. The secondary endpoint of hospitalization and/or ER visits related to Covid-19, showed an overall 78% reduction in risk of events across ensovibep arms compared to placebo. No deaths occurred in any of the patients treated with ensovibep. All doses were well-tolerated and no unexpected safety issues were identified for any of the doses.

Novartis told Molecular Partners of its intent to option its exclusive license to global rights of ensovibep, which will lead to a milestone payment. Molecular Partners will also be eligible to receive 22% royalty on sales. Molecular Partners has agreed to forgo royalties in lower income countries and is aligned with Novartis' plans to ensure affordability based on countries' needs and capabilities.

Novartis will become responsible for development, manufacturing, distribution and commercialization activities of ensovibep. Novartis has initiated scale-up activities in its large-scale biologics production facilities.

Molecular Partners estimates its cash runway to extend into 2025, excluding any potential royalty income as well as excluding potential further cash flows.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

January 10, 2022 06:51 ET (11:51 GMT)

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