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ProMIS Neurosciences Announces FDA Clearance of Investigational New Drug (IND) Application for PMN310 in Alzheimer’s Disease

Richard Powell  2 min read

ProMIS Neurosciences Inc. (TSX: PMN) (Nasdaq: PMN), a biotechnology company focused on the generation and development of antibody therapeutics targeting toxic misfolded proteins in neurodegenerative diseases such as Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and multiple system atrophy (MSA), today 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 demonstrated the ability to selectively target and protect against pathogenic Aβ oligomers
  • The IND clearance of PMN310 in the Alzheimer’s disease indication paves the way for initiation of clinical evaluation
  “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. “Our preclinical data demonstrated PMN310’s greater selective binding to toxic oligomers compared to other Aβ-directed antibodies, which we believe supports the potential clinical profile of PMN310. We look forward to advancing PMN310 into clinical development and sharing what we learn from this innovative work.”  

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. In a recent presentation of in vitro data at the AD/PD 2023 conference, PMN310 was the least impacted by monomer competition, compared to other Aβ-directed antibodies, resulting in an overall greater ability to target toxic oligomers. In addition, PMN310 was not observed to bind to plaque, potentially reducing the risk of Aβ-related imaging abnormalities (ARIA) observed with plaque-binding antibodies. The Company believes these data support a potentially differentiated clinical profile when compared to other antibody therapeutic candidates in AD.

  With the IND clearance for PMN310, the Company plans to initiate a Phase 1a clinical trial designed to evaluate the pharmacokinetics, safety and tolerability of a range of PMN310 doses in healthy adult volunteers.

 

ProMIS Neurosciences Inc. is a development stage biotechnology company focused on generating and developing antibody therapeutics selectively targeting toxic misfolded proteins in neurodegenerative diseases such as Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and multiple system atrophy (MSA). The Company’s proprietary target discovery engine is based on the use of two complementary techniques. The Company applies its thermodynamic, computational discovery platform - ProMIS and Collective Coordinates - to predict novel targets known as Disease Specific Epitopes on the molecular surface of misfolded proteins. Using this unique approach, the Company is developing novel antibody therapeutics for AD, ALS and MSA. ProMIS has offices in Toronto, Ontario and Cambridge, Massachusetts. ProMIS is listed on Nasdaq and the Toronto Stock Exchange under the symbol PMN.

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