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ProMIS Neurosciences Announces Full Year 2022 Financial Results and Recent Highlights
TORONTO, Ontario and CAMBRIDGE, Massachusetts, March 08, 2023 (GLOBE NEWSWIRE) -- Completed all preclinical studies and manufacturing to support PMN310 IND
About this update from Promis Neurosciences Inc.
[{"type":"text","content":"TORONTO, Ontario and CAMBRIDGE, Massachusetts, March 08, 2023 (GLOBE NEWSWIRE) -- Completed all preclinical studies and manufacturing to support PMN310 IND submission to U.S. Food and Drug AdministrationPreclinical data that further characterize ongoing programs, including PMN310, to be presented in 2023 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 its full year 2022 financial results and recent highlights. “This year looks to be a pivotal one for ProMIS as we continue our plans to advance PMN310, our novel Alzheimer’s disease product candidate, and expect to file our IND within the next 60 days,” said Gail Farfel, Ph.D., Chief Executive Officer of ProMIS Neurosciences. “Progressing to the clinical stage of development will be a significant step toward our goal of delivering a next-generation therapy to patients with Alzheimer’s disease who have limited options to slow cognitive decline. In addition, we are working to advance two discovery programs, PMN267 and PMN442, towards IND readiness and advancing our amyloid vaccine for AD. We look forward to sharing data from our ongoing efforts over the coming months.” Recent Highlights and Anticipated Milestones Alzheimer’s Disease Program (PMN310)PMN310, ProMIS’s lead compound, is a novel monoclonal antibody which is highly selective for toxic oligomers of amyloid-beta that are believed to be a major driver of AD. The Company has the following updates: Progressed preparation of the PMN310 investigational new drug application (IND), which is expected to be submitted to the U.S. Food and Drug Administration (FDA) within the next 60 days.Completed successful manufacture and packaging of PMN310 drug product under good manufacturing process (cGMP) for planned clinical trials.Completed non-human primate toxicology and pharmacokinetics studies, as well as tissue cross-reactivity studies under good laboratory practice (GLP) conditions to support first-in-human studies. PMN310 administered as a 30-minute weekly IV infusion to cynomolgus monkeys at dose levels of up to 1200 mg/kg/day was not associated with any adve...