ProMIS Neurosciences Doses First Patients in Phase 1b PRECISE-AD Trial of PMN310 for Alzheimer’s Disease
ProMIS Neurosciences has begun dosing multiple patients in its Phase 1b PRECISE-AD trial for Alzheimer's disease, marking a significant milestone for the company. The trial is evaluating PMN310, a humanized monoclonal antibody designed to selectively target toxic amyloid-beta oligomers while avoiding binding to monomers and amyloid plaques.
This selective targeting approach potentially differentiates PMN310 from other Alzheimer's treatments on the market or in development, with the goal of delivering a more effective and well-tolerated therapy. The rapid enrollment underscores the urgent unmet need for better Alzheimer's treatments.
The company expects six-month interim results in the first half of 2026, with topline results anticipated in the second half of 2026. Trial investigators highlighted that current Alzheimer's treatments offer only modest efficacy and often come with significant side effects like ARIA.
ProMIS Neurosciences ha iniziato a somministrare trattamenti a diversi pazienti nel suo studio di Fase 1b PRECISE-AD per la malattia di Alzheimer, segnando un traguardo significativo per l'azienda. Lo studio sta valutando PMN310, un anticorpo monoclonale umanizzato progettato per mirare selettivamente agli oligomeri tossici dell'amilode-beta evitando di legarsi ai monomeri e alle placche amiloidi.
Questo approccio di targeting selettivo potrebbe differenziare PMN310 dagli altri trattamenti per l'Alzheimer disponibili sul mercato o in fase di sviluppo, con l'obiettivo di fornire una terapia più efficace e ben tollerata. L'arruolamento rapido sottolinea l'urgente bisogno insoddisfatto di migliori trattamenti per l'Alzheimer.
L'azienda si aspetta risultati provvisori dopo sei mesi nella prima metà del 2026, con risultati principali previsti nella seconda metà del 2026. Gli investigatori dello studio hanno evidenziato che i trattamenti attuali per l'Alzheimer offrono solo un'efficacia modesta e spesso comportano effetti collaterali significativi come l'ARIA.
ProMIS Neurosciences ha comenzado a administrar tratamientos a múltiples pacientes en su ensayo de Fase 1b PRECISE-AD para la enfermedad de Alzheimer, marcando un hito significativo para la compañía. El ensayo está evaluando PMN310, un anticuerpo monoclonal humanizado diseñado para dirigirse selectivamente a los oligómeros tóxicos de amiloide-beta evitando unirse a los monómeros y placas de amiloide.
Este enfoque de selección de objetivos podría diferenciar a PMN310 de otros tratamientos para el Alzheimer en el mercado o en desarrollo, con el objetivo de ofrecer una terapia más efectiva y bien tolerada. La rápida inscripción subraya la urgente necesidad insatisfecha de mejores tratamientos para el Alzheimer.
La compañía espera resultados provisionales a los seis meses en la primera mitad de 2026, con resultados finales anticipados en la segunda mitad de 2026. Los investigadores del ensayo destacaron que los tratamientos actuales para el Alzheimer ofrecen solo una eficacia modesta y a menudo vienen con efectos secundarios significativos como ARIA.
ProMIS Neurosciences는 알츠하이머병에 대한 1b상 PRECISE-AD 시험에서 다수의 환자에 대한 투약을 시작하여 회사에 중요한 이정표를 세웠습니다. 이 시험은 PMN310을 평가하고 있으며, 이는 독성 아밀로이드-베타 올리고머를 선택적으로 표적화하도록 설계된 인간화된 단클론 항체입니다. 이 항체는 단량체 및 아밀로이드 플라크에 결합하는 것을 피합니다.
이러한 선택적 표적화 접근 방식은 PMN310을 시장에 있는 다른 알츠하이머 치료제나 개발 중인 치료제와 차별화할 가능성이 있으며, 더 효과적이고 잘 견디는 치료를 제공하는 것을 목표로 하고 있습니다. 신속한 등록은 더 나은 알츠하이머 치료에 대한 긴급한 미충족 수요를 강조합니다.
회사는 2026년 상반기에 6개월 중간 결과를 기대하고 있으며, 2026년 하반기에 주요 결과를 예상하고 있습니다. 시험 연구자들은 현재의 알츠하이머 치료가 단지 보통의 효능만 제공하며, 종종 ARIA와 같은 상당한 부작용을 동반한다고 강조했습니다.
ProMIS Neurosciences a commencé à administrer des traitements à plusieurs patients dans son essai de Phase 1b PRECISE-AD pour la maladie d'Alzheimer, marquant une étape importante pour l'entreprise. L'essai évalue PMN310, un anticorps monoclonal humanisé conçu pour cibler sélectivement les oligomères toxiques d'amyloïde-bêta tout en évitant de se lier aux monomères et aux plaques amyloïdes.
Cette approche de ciblage sélectif pourrait différencier PMN310 des autres traitements de l'Alzheimer sur le marché ou en cours de développement, avec l'objectif de fournir une thérapie plus efficace et mieux tolérée. L'inscription rapide souligne le besoin urgent non satisfait de meilleurs traitements pour l'Alzheimer.
L'entreprise s'attend à des résultats intermédiaires dans six mois au cours de la première moitié de 2026, avec des résultats principaux prévus dans la seconde moitié de 2026. Les chercheurs de l'essai ont souligné que les traitements actuels de l'Alzheimer n'offrent qu'une efficacité modeste et s'accompagnent souvent d'effets secondaires significatifs tels que l'ARIA.
ProMIS Neurosciences hat mit der Dosisverabreichung an mehreren Patienten in seiner Phase 1b PRECISE-AD Studie zur Alzheimer-Krankheit begonnen, was einen bedeutenden Meilenstein für das Unternehmen darstellt. Die Studie bewertet PMN310, einen humanisierten monoklonalen Antikörper, der entwickelt wurde, um toxische Amyloid-beta-Oligomere selektiv anzuvisieren, während er die Bindung an Monomere und Amyloid-Plaques vermeidet.
Dieser selektive Zielansatz könnte PMN310 von anderen Alzheimer-Behandlungen auf dem Markt oder in der Entwicklung unterscheiden, mit dem Ziel, eine effektivere und besser verträgliche Therapie zu liefern. Die schnelle Rekrutierung unterstreicht den dringenden ungedeckten Bedarf an besseren Alzheimer-Behandlungen.
Das Unternehmen erwartet sechsmonatige Zwischenresultate in der ersten Hälfte von 2026, mit Hauptergebnissen, die in der zweiten Hälfte von 2026 erwartet werden. Die Studienleiter hoben hervor, dass die aktuellen Alzheimer-Behandlungen nur eine bescheidene Wirksamkeit bieten und oft mit erheblichen Nebenwirkungen wie ARIA verbunden sind.
- PMN310 selectively targets toxic amyloid-beta oligomers while avoiding binding to monomers and plaques
- Rapid patient enrollment demonstrates strong interest in the trial
- PMN310 showed disease modifying capacity in preclinical models
- Six-month interim results expected in 1H 2026
- Topline results anticipated in 2H 2026
- No efficacy data available yet from human trials
- Results not expected until 2026
- Competing in crowded Alzheimer's treatment market
Insights
ProMIS Neurosciences has reached a significant milestone with the dosing of multiple patients in its Phase 1b PRECISE-AD trial for Alzheimer's disease. This development represents meaningful clinical progress for this $26 million market cap company, though investors should understand both the potential upside and the considerable timeline ahead.
The company's approach with PMN310 targets a specific mechanism that differentiates it from current FDA-approved antibodies like Leqembi and Aduhelm. While those drugs bind broadly to amyloid beta, PMN310 is engineered to selectively target toxic amyloid-beta oligomers while avoiding monomers and plaques. This selectivity could theoretically address a key limitation of existing therapies - the ARIA (amyloid-related imaging abnormalities) side effects that cause brain swelling and microhemorrhages in approximately 13-17% of patients on current treatments.
The trial's rapid enrollment reflects the massive unmet need in Alzheimer's treatment, with over 6 million Americans affected and effective options. However, investors should note the extended timeline - interim results aren't expected until 1H 2026 with topline data in 2H 2026. This suggests at least 15-18 months of cash burn before meaningful efficacy signals emerge.
For a company with resources, this timeline raises questions about funding. ProMIS will likely need additional capital to reach these data readouts, creating potential dilution risk for current shareholders. The company's broader pipeline including programs for ALS and MSA provides some portfolio diversification but also stretches resources further.
The inclusion of biomarker assessments in this trial is strategically important. Positive biomarker data showing target engagement or downstream effects could provide early validation of the mechanism and potentially create interim catalysts before full efficacy results.
While this Phase 1b milestone demonstrates operational execution, ProMIS remains years away from potential commercialization. The risk-reward profile is typical of early-stage biotech - significant upside potential if PMN310 shows superior efficacy and safety, balanced against substantial clinical, regulatory, and financial hurdles ahead.
Rapid Enrollment and Dosing of First Patients Encouraging and Underscores Unmet Need for Better Treatment Options for Alzheimer’s Disease
Six-month Interim Results Expected in 1H 2026 with Topline Results Anticipated in 2H 2026
CAMBRIDGE, Massachusetts, Feb. 25, 2025 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage 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 important progress in the PRECISE-AD Phase 1b clinical trial with the dosing of multiple patients with its lead drug candidate, PMN310, designed for the treatment of Alzheimer’s disease (AD). The dosing of several patients marks an important milestone in assessing the safety, tolerability, and pharmacokinetics of PMN310 and underscores ProMIS’s commitment to addressing the urgent need for targeted therapies in AD by selectively targeting toxic oligomers, which we believe to be a key driver of disease progression.
PMN310 is a humanized monoclonal antibody (mAb) designed and developed to selectively target only soluble amyloid-beta oligomers (AβOs), which are believed to be the most toxic and pathogenic form of Aβ, while avoiding any binding to Aβ monomers and amyloid plaques.
“The initiation of dosing in multiple patients in our Phase 1b PRECISE-AD trial marks a significant milestone for ProMIS Neurosciences,” said Neil Warma, Chief Executive Officer of ProMIS Neurosciences. “With a growing need for more effective and safer treatments for Alzheimer’s disease, we are excited to take this critical step toward demonstrating PMN310’s potential to make a real difference for patients and their families. We look forward to generating clinical data and furthering our commitment to transforming Alzheimer’s treatment."
“The PRECISE-AD trial has been carefully designed to generate potentially robust clinical data, including biomarker insights and efficacy signals that will guide the next phase of development. We believe PMN310’s selective binding to toxic Aβ oligomers and not to plaque or monomers differentiates it from other drugs currently on the market or in development and we believe we have the potential to deliver a more effective and well-tolerated treatment for patients suffering from Alzheimer’s disease,” added Mr. Warma.
“As physicians dedicated to advancing Alzheimer’s research, we are excited to be part of the PRECISE-AD trial evaluating PMN310,” said Yaneicy Gonzalez-Rojas, M.D. and Ahmad Aswad, M.D., Investigators of the PRECISE-AD clinical trial. “Alzheimer’s disease remains one of the greatest unmet medical needs, and patients urgently need new treatment options that are both effective and well-tolerated. Current AD treatments offer only modest efficacy and are often accompanied by significant side effects, such as ARIA. PMN310’s novel and selective targeting of amyloid oligomers has shown disease modifying capacity for AD in preclinical models, which we believe is promising and offers hope to Alzheimer’s patients and their loved ones.”
About PRECISE-AD Phase 1b Clinical Trial
The ongoing PRECISE-AD 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 will also evaluate key biomarkers and clinical measures of efficacy to gather data on PMN310’s therapeutic potential. The PRECISE-AD 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.
About PMN310
PMN310 is a humanized monoclonal antibody (mAb) designed and developed based on its selectivity for soluble amyloid-beta oligomers (AβOs), which are believed to be the most toxic and pathogenic form of Aβ, relative to Aβ monomers and amyloid plaques. Soluble AβOs have been observed to be potent neurotoxins that bind to neurons, impair synaptic function and induce neurodegeneration. By selectively targeting toxic soluble AβOs, 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.
About ProMIS Neurosciences Inc.
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). The Company’s proprietary target discovery engine applies a thermodynamic, computational discovery platform - ProMIS™ and Collective Coordinates - to predict novel targets known as Disease Specific Epitopes on the molecular surface of misfolded proteins. PMN310, the Company’s lead product candidate for the treatment of AD, is a differentiated, humanized monoclonal antibody that has been designed to specifically bind toxic Aβ oligomers and to not bind plaque or monomers. Oligomers are known to drive disease progression in AD and PMN310 appears to selectively bind oligomers. PMN 310 has successfully completed a Phase 1a clinical study and is dosing Alzheimer’s disease patients in a Phase 1b clinical trial in AD patients. ProMIS has offices in Cambridge, Massachusetts and Toronto, Ontario.
Forward-Looking Statements
Nasdaq has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. Certain information in this news release constitutes forward-looking statements and forward-looking information (collectively, “forward-looking information”) within the meaning of applicable securities laws. In some cases, but not necessarily in all cases, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “targets”, “expects” or “does not expect”, “is expected”, “excited about”, “an opportunity exists”, “is positioned”, “estimates”, “intends”, “assumes”, “anticipates” or “does not anticipate” or “believes”, or variations of such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “might”, “will” or “will be taken”, “occur” or “be achieved”. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances contain forward-looking information. Specifically, this news release contains forward-looking information relating to the Company's progress, including enrollment and dosing for its Phase 1b clinical trial, and planned timing for completion and anticipated data readout of interim and full results from the Phase 1b clinical trial in AD patients, 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 Aβ are a major driver of AD) and have greater therapeutic potential due to reduction of off-target activity, a computationally-derived Aβ vaccine for AD and the Company’s PMN310 antibody and vaccine candidate and management’s belief that its patented platform technology has created an antibody candidate specific to toxic misfolded oligomers known to be present in AD, therapeutic activity and preferential targeting of toxic soluble aggregates by Aß-directed antibodies and the potential implications thereof. Statements containing forward-looking information are not historical facts but instead represent management's current expectations, estimates and projections regarding the future of our business, future plans, strategies, projections, anticipated events and 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 known and unknown risks, uncertainties and assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking information, including, but not limited to, the risk that preclinical results or early results may not be indicative of future results, the Company’s 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 “Risk Factors” section of the Company's most recently filed Annual Report on Form 10-K for the year ended December 31, 2023 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.
For further information:
Visit us at www.promisneurosciences.com
Please submit media inquiries to info@promisneurosciences.com
For Investor Relations, please contact:
Precision AQ (formerly Stern IR)
Anne Marie Fields, Managing Director
annemarie.fields@precisionaq.com
Tel. 212-362-1200
FAQ
What is PMN310 and how does it differ from other Alzheimer's treatments?
When will ProMIS Neurosciences (PMN) release results from the PRECISE-AD trial?
What phase is the PMN310 Alzheimer's clinical trial currently in?
What advantages might PMN310 have over existing Alzheimer's treatments?
How many patients have been dosed in the PMN310 PRECISE-AD trial so far?
