ProMIS Neurosciences (TSX:PMN) told investors it has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for PMN310 for the treatment of Alzheimer’s disease (AD).
The development stage biotechnology company explained that PMN310 is a novel monoclonal antibody which is designed to be highly selective for toxic oligomers of amyloid-beta that are believed to be a major driver of AD, as opposed to monomers or plaque.
In preclinical studies, the company noted that PMN310 showed strong ex vivo target engagement of toxic oligomers in brain samples from patients with AD. In a recent presentation of in vitro data at the AD/PD (Parkinson’s disease) 2023 conference, it said PMN310 compared to other amyloid-beta-directed antibodies was the least impacted by monomer competition, resulting in an overall greater toxic oligomer binding level versus all comparators.
“This submission is an important milestone for the ProMIS team as we advance our lead compound, PMN310, toward the clinic,” ProMIS CEO Dr Gail Farful said in a statement.
“We are excited to continue the development of PMN310 to potentially provide a new treatment option with a differentiated profile for patients with Alzheimer’s disease. We look forward to our transition to a clinical-stage company, pending regulatory clearance of the IND,” Farful added.
Contact the author at stephen.gunnion@proactiveinvestors.com