ProMIS Neurosciences Starts Phase 1b Trial of PMN310 for Alzheimer’s Disease

"ProMIS Neurosciences Inc., a clinical-stage biotechnology company focused on developing precision therapies for neurodegenerative diseases, announced the initiation of its phase 1b clinical trial (PRECISE-AD) evaluating its lead therapeutic candidate, PMN310, in Alzheimer’s disease (AD).

PMN310, a humanized IgG1 antibody, is engineered to selectively target toxic oligomers of amyloid-beta (AßO)—which are believed to be a key driver of Alzheimer’s pathology—while avoiding interaction with plaque deposits. This mechanism is designed to help reduce the risk of amyloid-related imaging abnormalities (ARIA), a common side effect associated with existing therapies, potentially offering a differentiated product profile.

The ongoing phase 1b PRECISE-AD trial will assess the safety, tolerability, and pharmacokinetics of PMN310 over 12 months of treatment in 100 patients with mild cognitive impairment (MCI) due to AD (Stage 3 AD) or early AD (Stage 4 AD). The study will also evaluate key biomarkers and clinical measures of efficacy to gather data on PMN310’s therapeutic potential. Results from the recently completed phase 1a study in healthy volunteers demonstrated a generally favourable safety and tolerability profile, with drug concentrations in cerebrospinal fluid supporting its potential for robust target engagement in patients with AD.

“The initiation of the PRECISE-AD trial is a major milestone in our journey to develop PMN310 as a potential treatment for AD,” said Neil Warma, CEO of ProMIS Neurosciences. “Current AD treatments offer only modest efficacy, often accompanied by significant side effect challenges such as ARIA, leaving a substantial unmet need for new options. We believe PMN310 has the potential to deliver on this need through its selective targeting mechanism.”

“We have partnered with some of the best AD treatment centers 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.”

“Flourish Research is excited to partner with ProMIS Neurosciences on the research and development of their novel medication PMN310,” said Cameron S. Olezene, M.D., Principal Investigator at Flourish Research in Philadelphia, one of the first sites to become activated in the PRECISE-AD trial.  “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.”

Warma added “the trial name, PRECISE-AD, was chosen to reflect our focus on Personalized, Robust, and Effective Clinical Intervention with Specificity and Excellence in addressing Alzheimer’s disease. This name underscores our commitment to precision therapies, leveraging advanced science to selectively target the root causes of AD and deliver meaningful outcomes for patients. It also reflects the goal of the study design, which is to demonstrate PRECISE targeting of toxic oligomers by PMN310 in Alzheimer’s disease.”

The phase 1b clinical trial (NCT06750432) 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 Stage 3 and Stage 4 AD. The study plans to enroll approximately 100 subjects across 22 active sites in the United States. Eligible patients will be dosed monthly at one of the three dose levels or placebo over 12 months with assessment of safety, tolerability, PK, and pharmacodynamic blood- and brain-based markers of treatment effect at baseline and every three months. Frequent MRI scans throughout the study will be conducted to monitor for emergence of ARIA.

PMN310 is a humanized monoclonal antibody (mAb) designed and developed based on its selectivity for soluble amyloid-beta oligomers (AßOs), which are believed to be the most toxic and pathogenic form of Aß, relative to Aß monomers and amyloid plaques. Soluble AßOs have been observed to be potent neurotoxins that bind to neurons, impair synaptic function and induce neurodegeneration. By selectively targeting toxic soluble AßOs, PMN310 aims to directly address the growing body of evidence indicating they may be the primary underlying cause of the neurodegenerative process in Alzheimer’s disease.

PMN310 has successfully completed a phase 1a clinical study (NCT06105528), a double-blind, placebo-controlled, single ascending dose study of the safety, tolerability and pharmacokinetics of PMN310 infusions in healthy volunteers.

ProMIS Neurosciences Inc. is a clinical 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).

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!