Molecular Partners’ COVID-19 drug demonstrates efficacy

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10.01.2022
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In a Phase 2 study envisobip lowered the viral load and reduced the risk of hospitalisations, emergency room visits or death. Novartis confirms it will now exercise its option to in-license ensovibep from Molecular Partners. Upon completion of in-licensing, Molecular Partners will receive a milestone payment of 150M CHF and be entitled to a 22% royalty on sales of ensovibep in commercial territories.

Molecular Partners, a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, and Novartis today announced that Part A of the EMPATHY clinical trial, that compared single intravenous doses of ensovibep, a DARPin antiviral therapeutic candidate vs. 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. 

The global EMPATHY clinical trial, which is being conducted by Novartis, with Molecular Partners as sponsor, is a randomized, double-blind, placebo controlled study in ambulatory (non-hospitalized) adult patients with COVID-19. EMPATHY Part A enrolled 407 patients to identify a dose of ensovibep with optimal safety and efficacy and recruited patients in the USA, South Africa, India, the Netherlands, and Hungary to explore three doses: 75mg, 225mg and 600mg.

Given the pressing public health emergency and the rapid spread of the Omicron variant across the world, Novartis and Molecular Partners are in close liaison with regulatory bodies to seek expedited review and approval of ensovibep as soon as possible. If approved, ensovibep will be the first multi-specific antiviral molecule for the treatment of COVID-19.

Novartis has informed Molecular Partners of its intent to option its exclusive license to global rights of ensovibep, which will lead to a milestone payment of CHF 150m. In addition, Molecular Partners will 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. With the decision made to exercise the option, Novartis will become responsible for development, manufacturing, distribution and commercialization activities of ensovibep. Novartis has already initiated scale-up activities in its large-scale biologics production facilities. 

Financial guidance updateThe Company expects approximately CHF 133 million cash and cash equivalents as per December 31, 2021. Upon receipt of the CHF 150 million option exercise milestone from Novartis, Molecular Partners now estimates its cash runway to extend well into 2025, excluding any potential royalty income as well as excluding potential further cash flows to or from R&D partners.

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