Emergency Use Authorization Request for Ensovibep Submitted to the US Food and Drug Administration for the Treatment of COVID-19
ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., Feb. 10, 2022 (GLOBE NEWSWIRE) — Ad hoc announcement pursuant to Art. 53 LR: Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, was informed by its partner Novartis that the company has requested Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for ensovibep, a DARPin antiviral therapeutic candidate to treat COVID-19.
This submission is based on the totality of the data from clinical and preclinical studies including the positive results of the Phase 2 portion of the EMPATHY study, a randomized, placebo-controlled study which enrolled 407 symptomatic patients infected with SARS-Cov-2.
Ensovibep is a DARPin therapeutic candidate, designed specifically to inhibit target cell entry of SARS-CoV-2, the virus that causes COVID-19. DARPins (Designed Ankyrin Repeat Proteins) are mono or multi-specific protein-based therapies, designed to specifically engage their targets for various effects. Ensovibep includes three covalently linked individual DARPin domains which bind to the spike protein of SARS-CoV-2. With these domains incorporated into a single molecule, ensovibep is designed to block the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein, even in the presence of some mutations of the spike protein. Several characteristics of DARPin therapeutics make them potentially suitable for COVID-19 treatment, including multi-specific binding, the rapid onset of action, and scalable bacterial production.
About Molecular Partners AG
Molecular Partners AG is a clinical-stage biotech company developing DARPin therapeutics, a new class of custom-built protein drugs designed to address challenges current modalities cannot. The Company has formed partnerships with leading pharmaceutical companies to advance DARPin therapeutics in the areas of ophthalmology, oncology and infectious disease, and has compounds in various stages of clinical and preclinical development across multiple therapeutic areas. www.molecularpartners.com; Find us on Twitter – @MolecularPrtnrs