Canadian biotech ProMIS Neurosciences has initiated a Phase Ib trial of its lead therapeutic candidate, PMN310, designed to treat Alzheimer’s disease by selectively targeting toxic oligomers of amyloid-beta (AβO).
Thought to be one of the drivers behind the development of Alzheimer’s, ProMIS’ PMN310 is designed to target AβO in hopes of slowing disease progression reduce the risk of amyloid-related imaging abnormalities (ARIA), a common side effect associated with existing Alzheimer’s disease-modifying therapies.
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Dubbed the PRECISE-AD trial (NCT06750432), the trial will be a randomised, double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics of PMN310 in doses ascending from 5mg through to 20mg in approximately 100 patients living with stage 3 and 4 Alzheimer’s disease across 22 sites in the US.
Neil Warma, CEO of ProMIS Neuroscience, said: “We have partnered with some of the best Alzheimer’s disease treatment centres in the US for this trial and they are actively screening and enrolling patients. The PRECISE-AD trial has been carefully designed to generate robust clinical data, including biomarker insights and efficacy signals that will guide the next phase of development. We are excited about the opportunity to deliver real innovation to patients and look forward to sharing updates as we progress, with certain interim data anticipated in the first half of 2026.”
The company added that results from its recently completed Phase I study that examined the drug in healthy volunteers demonstrated a generally favourable safety and tolerability profile.
Research by GlobalData estimates that the Alzheimer’s disease market is expected to grow at a high compound annual growth rate (CAGR) of 23.4% from $2.4bn in 2023 to $19.3bn by 2033 across the eight major markets, driven largely by an ageing population.
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Two Alzheimer’s disease monoclonal antibodies have been approved by the US Food and Drug Administration, Eli Lilly’s Kisunla (donanemab) and Eisai and Biogen’s Leqembi (lecanemab). Both drugs act by removing amyloid plaques from a patient’s brain to slow the progression of the disease. Eisai and Biogen also developed another monoclonal antibody, Aduhelm (aducanumab), but the therapy was recently discontinued due to safety concerns.
Cameron Olezene, principal investigator at partnered research firm, Flourish Research in Philadelphia, added: “Monoclonal antibodies targeting toxic amyloid-beta species are the first treatments that have shown disease modifying capacity for Alzheimer’s disease. It is often preferable to have multiple therapeutics available as treatment options. Thus, PMN310 is exciting because of its novel targeting of amyloid oligomers, potentially offering another solution for physicians and their patients.”
