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February 11, 2022

Novartis seeks FDA EUA for Covid-19 antiviral candidate ensovibep

The latest submission to the FDA is based on the totality of the data from the clinical and preclinical studies of ensovibep.

Molecular Partners has reported that its partner Novartis sought emergency use authorization (EUA) for the antiviral candidate, ensovibep, from the US Food and Drug Administration (FDA) to treat Covid-19. 

A Designed Ankyrin Repeat Protein (DARPin) antiviral therapeutic candidate, ensovibep can specially hinder the SARS-CoV-2 virus’ target cell entry. 

It comprises three covalently associated individual DARPin domains that can attach to the viral spike protein. 

With these domains combined into a single molecule, the antiviral candidate can inhibit the SARS-CoV-2 spike protein’s receptor-binding domain (RBD), even when mutations occur in the spike protein. 

The latest submission to the FDA is based on the entirety of the results from clinical and preclinical studies.

It includes positive findings from the Phase II segment of the randomised, placebo-controlled EMPATHY trial that enrolled 407 subjects with symptomatic Covid-19.

In January, the companies reported positive results from the Part A of the EMPATHY trial.

Conducted by Novartis and sponsored by Molecular Partners, the global trial in the ambulatory setting analysed ensovibep’s optimal safety and efficacy in subjects in the US, South Africa, India, the Netherlands and Hungary.

Data showed that the trial that analysed single intravenous doses of ensovibep met the primary endpoint of decline in viral load over eight days. 

On the secondary endpoint of hospital admission and/or Emergency Room (ER) visits linked to Covid-19 or mortality, or death, an overall risk decline of 78% in events across ensovibep groups versus placebo were reported.

A clinically meaningful benefit compared to placebo was observed in time to sustained clinical recovery, another secondary endpoint of the trial.

Furthermore, no deaths were reported in subjects who received ensovibep.

With the positive results, Novartis had confirmed plans to exercise its option for in licensing ensovibep from Molecular Partners.

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