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ProMIS Neurosciences (TSX:PMN) notches FDA clearance for Alzheimer’s disease treatment

Health Care, Market News
TSX:PMN
08 May 2023 11:54 (EDT)

ProMIS Neurosciences (PMN) notches US Food and Drug Administration (FDA) clearance for its investigational new drug application (IND) for its Alzheimer’s disease treatment.

Its PMN310 treatment is a novel monoclonal antibody intended to be highly selective for toxic oligomers of amyloid-beta that are major factors in Alzheimer’s disease.

Thanks to the IND clearance, the company said this will lead the way toward the clinical evaluation of PMN310.

“Receiving IND clearance for PMN310 marks an important corporate milestone as we continue towards our goal of delivering next-generation therapy to patients with Alzheimer’s disease who have limited options to slow cognitive decline,” Gail Farfel, CEO of ProMIS Neurosciences, said in a release.

PMN310 has shown in preclinical studies strong ex vivo target engagement of toxic oligomers from brain samples of people with Alzheimer’s disease. Ex vivo is a medical procedure in which cells or tissue are taken from a person for a treatment or procedure and then placed back inside the individual.

The company now intends to begin a Phase1a clinical trial of PMN310 to evaluate the pharmacokinetics, safety and tolerability of PMN310 in healthy adult volunteers.

Shares of ProMIS Neurosciences (PMN) are up 3.14 per cent to C$9.20 as of 10:00 a.m. EDT.

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