by Chris Wack
Shares of Molecular Partners AG rose 37% to $22.60 in premarket trading after the company and Novartis said part A of their clinical trial comparing single intravenous doses of ensovibep, a DARPin antiviral therapeutic candidate, versus placebo for COVID-19. To treat, met the primary endpoint. Viral load reduction in eight days.
The company said two secondary endpoints in the study also showed a clinically meaningful benefit over placebo: the overall endpoint of hospitalization and/or emergency room visits or death, and time to continuous clinical improvement.
Novartis said it will exercise its option to in-license ensovibep from Molecular Partners and, after the option is exercised, seek early access globally through the Food and Drug Administration’s EUA process.
The clinical trial, which is being conducted by Novartis with Molecular Partners as a sponsor, is a placebo controlled study in ongoing adult patients with COVID-19. Part A enrolled 407 patients to identify a single dose of Ensovibep with optimal safety and efficacy and enrolled patients in the US, South Africa, India, the Netherlands and Hungary to explore three doses: 75mg, 225mg and 600mg.
Study results showed that the primary endpoint was a statistically significant reduction in viral load at eight days compared to placebo for all three dosing arms. The secondary endpoint of COVID-19-related hospitalization and/or ER visits showed an overall 78% reduction in the risk of events in the 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 problems were identified for any dose.
Novartis informed Molecular Partners of its intention to substitute its exclusive license for the global rights to Ensovibep, which will mark a milestone payment. Molecular Partners will also be eligible to receive 22% royalty on sales. Molecular Partners has agreed to waive royalties in low-income countries and aligned with Novartis’ plans to ensure affordability based on countries’ needs and capabilities.
Novartis will be responsible for the development, manufacturing, distribution and commercialization activities of Ensovibep. Novartis has launched large-scale activities at its large-scale biologics production facilities.
Molecular Partners anticipates that its cash runway will be extended through 2025, excluding any potential royalty income as well as potential forward cash flows.
Write to Chris Wack at [email protected]