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ProMIS Neurosciences Granted Fast Track Designation by U.S. FDA for PMN310 in the Treatment of Alzheimer鈥檚 Disease

FDA designation highlights the potential of PMN310 to deliver a more targeted approach to treating Alzheimer鈥檚 Disease

CAMBRIDGE, Mass., July 21, 2025 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company committed to the discovery and development of therapeutic antibodies targeting toxic misfolded proteins in neurodegenerative diseases, such as Alzheimer鈥檚 disease (AD), amyotrophic lateral sclerosis (ALS) and Parkinson鈥檚 disease (PD), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PMN310, the Company鈥檚 lead therapeutic candidate in development for the treatment of Alzheimer鈥檚 disease (AD).

The FDA Fast Track program is intended to accelerate the development of therapies that aim to address serious conditions and fill an unmet medical need. This designation enables enhanced engagement with the FDA, opening the door to a potentially more efficient path to approval for PMN310.

鈥淭his is a pivotal moment for ProMIS and the Alzheimer鈥檚 community, as receiving Fast Track designation not only underscores the potential of PMN310 to address a critical unmet need, but also provides valuable opportunities for regulatory insight as we advance toward key clinical milestones,鈥� said Neil Warma, President and Chief Executive Officer of ProMIS Neurosciences. 鈥淲e designed PMN310 with a goal of providing Alzheimer鈥檚 patients with a safer and more efficacious treatment option, which we believe represents the next generation of Alzheimer鈥檚 therapeutics. By selectively targeting only the most harmful, toxic forms of amyloid-beta, we believe PMN310 has the potential to reduce the serious side effects seen with current Alzheimer鈥檚 treatments, namely brain swelling and bleeding known as ARIA, while also delivering improved therapeutic benefit to patients.鈥�

The ongoing PRECISE-AD Phase 1b trial is evaluating PMN310 in patients with early AD. The study is focused on characterizing safety, tolerability, pharmacokinetics, and disease-relevant biomarkers. ProMIS anticipates reporting interim six-month biomarker and safety data in Q2 鈥�26 and final results in Q4 鈥�26.

AD affects more than 6 million people in the U.S. and remains a leading cause of death and disability among older adults. Despite progress in the field, the need for safer, more targeted treatment options remains urgent.

About PMN310 and the PRECISE-AD Trial for Alzheimer鈥檚 Disease (AD)

PMN310, the Company鈥檚 lead product candidate for the treatment of AD, is a humanized monoclonal antibody that has been designed to be differentiated in its ability to selectively target only the toxic oligomers, avoiding plaque, thereby potentially reducing or eliminating ARIA liability. In addition, because PMN310 may not be limited by off-target binding or side effects, PMN310 could potentially offer an improved efficacy profile over other amyloid-directed antibody therapeutics.

Based on the encouraging results from the Phase 1a trial () of PMN310, ProMIS initiated PRECISE-AD, a Phase 1b clinical trial in AD patients. PRECISE-AD () is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics (PK) of multiple ascending doses (5, 10, 20 mg/kg) of intravenous PMN310 in patients with Mild Cognitive Impairment due to AD and mild AD (Stage 3 and Stage 4 AD).聽 PRECISE-AD will be the first study to examine the effects of a monoclonal antibody directed solely against A尾O on biomarkers associated with AD pathology and clinical outcomes. Safety will be a primary outcome of the study with particular emphasis on assessing whether, as a non-plaque binder, PMN310 may have a reduced risk of ARIA. The study is powered to provide 95% confidence for detection of ARIA. The study has been designed with a sample size intended to provide sufficient power to provide meaningful insight into effects of PMN310 on biomarkers and clinical outcomes.

About ProMIS Neurosciences Inc.

ProMIS Neurosciences is a clinical-stage biotechnology company committed to the discovery and development of therapeutic antibodies selective for toxic oligomers associated with the development and progression of neurodegenerative and other misfolded protein diseases. The Company鈥檚 proprietary target discovery engine, EpiSelect鈩�, predicts novel targets known as Disease Specific Epitopes (DSEs) on the molecular surface of misfolded proteins that cause neurodegenerative and other misfolded protein diseases, including Alzheimer鈥檚 disease (AD), amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD), multiple system atrophy (MSA), and Parkinson鈥檚 Disease (PD). ProMIS has offices in Cambridge, Massachusetts (USA) and Toronto, Ontario (CAN).

Forward-Looking Statements

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Certain information in this news release constitutes forward-looking statements and forward-looking information (collectively, 鈥庘�庘�渇orward-looking information鈥�) within the meaning of applicable securities laws. In some cases, but not necessarily in all cases, forward-looking information can be identified by the 鈥巙se of forward-looking terminology such as 鈥減lans鈥�, 鈥減leased to鈥�, 鈥渓ook forward to鈥�, 鈥減otential to鈥�, 鈥渢argets鈥�, 鈥渆xpects鈥� or 鈥渄oes not expect鈥�, 鈥渋s expected鈥�, 鈥渆xcited about鈥�, 鈥渁n opportunity exists鈥�, 鈥庘�庘�渋s positioned鈥�, 鈥渆stimates鈥�, 鈥渋ntends鈥�, 鈥渁ssumes鈥�, 鈥渁nticipates鈥� or 鈥渄oes not anticipate鈥� or 鈥渂elieves鈥�, or variations of such words and 鈥巔hrases or state that certain actions, events or results 鈥渕ay鈥�, 鈥渃ould鈥�, 鈥渨ould鈥�, 鈥渕ight鈥�, 鈥渨ill鈥� or 鈥渨ill be taken鈥�, 鈥渙ccur鈥� or 鈥渂e 鈥巃chieved鈥�. In addition, any statements that refer to expectations, projections or other characterizations of future events or 鈥巆ircumstances contain forward-looking information. Specifically, this news release contains forward-looking information relating to the Company's progress and expectations for its Phase 1b clinical trial in AD patients, including planned timing for completion and anticipated data readout of interim and full results, the potential for such studies to provide the first proof-of-concept data for PMN310, the potential that PMN310 has the potential to positively benefit patients with AD and to be a more effective and well-tolerated option, the targeting of toxic misfolded proteins in neurodegenerative diseases that the Company believes may directly address fundamental AD pathology (including the belief and understanding that toxic oligomers of A尾 are a major driver of AD) and have greater therapeutic potential due to reduction of off-target activity and the Company鈥檚 expectations regarding the benefits of Fast Track Designation. Statements containing forward-looking information are not historical facts but instead represent management's current 鈥巈xpectations, estimates and projections regarding the future of our business, future plans, strategies, projections, anticipated events 鈥巃nd trends, the economy and other future conditions. Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by the Company as of the date of this news release, are subject to 鈥巏nown and unknown risks, uncertainties and assumptions and other factors that may cause the actual results, level of activity, 鈥巔erformance or achievements to be materially different from those expressed or implied by such forward-looking information, including, but not limited to, the risk that clinical results or early results may not be indicative of future results, the Company鈥檚 ability to retain and recognize the incentives conferred by Fast Track Designation for PMN310, the Company鈥檚 ability to fund its operations and continue as a going concern, its accumulated deficit and the expectation for continued losses and future financial results. Important factors that could cause actual results to differ materially from those indicated in the forward-looking information include, among others, the factors discussed throughout the 鈥淩isk Factors鈥� section of the Company's most recently filed Annual Report on Form 10-K for the year ended December 31, 2024 and in its subsequent filings filed with the United States Securities and Exchange Commission. Except as required by applicable securities laws, the Company undertakes no obligation to publicly update any forward-looking information, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

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