Pharma Focus Asia

ProMIS Neurosciences Announces FDA Clearance of Investigational New Drug (IND) Application for PMN310

Tuesday, May 09, 2023

ProMIS Neurosciences announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for PMN310 for the treatment of AD. 

PMN310 is a novel monoclonal antibody which is designed to be highly selective for toxic oligomers of amyloid-beta (Aβ) that are believed to be a major driver of AD. In preclinical studies, PMN310 showed strong ex vivo target engagement of toxic oligomers in brain samples from patients with AD, with little or no diversion by Aβ monomers or plaque.

Receiving IND clearance for PMN310 marks an important corporate milestone towards the goal of delivering next-generation therapy to patients with Alzheimer’s disease who have limited options to slow cognitive decline. The preclinical data demonstrated PMN310’s greater selective binding to toxic oligomers compared to other Aβ-directed antibodies, which supports the potential clinical profile of PMN310.

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