Investigational Monoclonal Antibody Which Targets Toxic Amyloid Beta Oligomers Receives IND Clearance from FDA

ProMIS Neuroscience (Toronto, Ontario, Canada; and Cambridge, MA) reported that it received clearance from the Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for PMN310 for the treatment of Alzheimer disease (AD). Clearance was based on results from preclinical studies, including data presented at the International Conference on Alzheimer’s and Parkinson’s Disease and Related Neurological Disorders (AD/PD 2023) which showed PMN310 to be more effective at targeting toxic amyloid beta oligomers in brain samples compared with other monoclonal antibody therapies which target amyloid beta aggregates such as fibrils and plaques. Results showed that PMN310 did not bind to amyloid beta monomers or to plaques.

PMN310 represents a monoclonal antibody directed at a conformational amyloid beta epitope predicted by computational modeling to be present in toxic amyloid beta oligomers. Early laboratory studies have shown that PMN310 inhibits amyloid beta oligomer propagation.

“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,” said Gail Farfel, Ph.D., Chief Executive Officer of ProMIS Neurosciences.

As a next step, ProMIS Neuroscience plans to initiate an exploratory phase 1a clinical trial designed to assess the pharmacokinetics, safety, and tolerability of a variety of doses of PMN310 in healthy adults.