ProMIS Neurosciences Presents Positive Data from PMN310 Phase1a Clinical Trial at the 17th Clinical Trials on Alzheimer’s Disease Conference
ProMIS Neurosciences presented positive results from its Phase 1a clinical trial of PMN310, an investigational monoclonal antibody targeting toxic amyloid beta oligomers for Alzheimer's disease, at the 17th CTAD Conference. The trial, involving 40 healthy volunteers across five dose cohorts (2.5-40 mg/kg), demonstrated that PMN310 was generally well-tolerated and effectively crossed the blood-brain barrier. The pharmacokinetic data suggests monthly dosing could provide adequate levels for target engagement in AD patients. Based on these results, the company plans to initiate a 12-month Phase 1b trial in 100 patients with mild cognitive impairment due to AD and early AD by year-end 2024.
ProMIS Neurosciences ha presentato risultati positivi dal suo studio clinico di Fase 1a di PMN310, un anticorpo monoclonale in fase di ricerca mirato agli oligomeri tossici della beta-amiloide per l'Alzheimer, durante la 17ª Conferenza CTAD. Lo studio, che ha coinvolto 40 volontari sani suddivisi in cinque coorti di dosaggio (2.5-40 mg/kg), ha dimostrato che PMN310 è stato generalmente ben tollerato e ha attraversato efficacemente la barriera emato-encefalica. I dati farmacocinetici suggeriscono che una somministrazione mensile potrebbe fornire livelli adeguati per l'interazione con il target nei pazienti affetti da AD. Sulla base di questi risultati, l'azienda prevede di avviare uno studio di Fase 1b della durata di 12 mesi su 100 pazienti con lieve compromissione cognitiva dovuta a AD e AD precoce entro la fine del 2024.
ProMIS Neurosciences presentó resultados positivos de su ensayo clínico de Fase 1a de PMN310, un anticuerpo monoclonal en investigación que se dirige a los oligómeros tóxicos de beta-amiloide para la enfermedad de Alzheimer, en la 17ª Conferencia CTAD. El ensayo, que involucró a 40 voluntarios sanos en cinco cohortes de dosis (2.5-40 mg/kg), demostró que PMN310 fue generalmente bien tolerado y cruzó eficazmente la barrera hematoencefálica. Los datos farmacocinéticos sugieren que una dosificación mensual podría proporcionar niveles adecuados para la interacción con el objetivo en pacientes con EA. Basándose en estos resultados, la empresa planea iniciar un ensayo de Fase 1b de 12 meses en 100 pacientes con deterioro cognitivo leve debido a EA y EA temprana a finales de 2024.
ProMIS Neurosciences는 17차 CTAD 학회에서 알츠하이머병을 대상으로 하는 독성 아밀로이드 베타 올리고머를 겨냥한 실험용 단클론 항체 PMN310의 1상 임상 시험 결과를 발표했습니다. 이 시험은 5개의 용량 집단(2.5-40 mg/kg)에서 40명의 건강한 자원자를 대상으로 진행되었으며, PMN310이 일반적으로 잘 견디는 것으로 나타났고 혈뇌 장벽을 효과적으로 통과했습니다. 약물 동태 데이터는 월별 투여가 알츠하이머 환자에서 목표 개입을 위한 적절한 수준을 제공할 수 있음을 시사합니다. 이러한 결과를 바탕으로 회사는 2024년 말까지 알츠하이머로 인한 경도 인지 장애가 있는 100명의 환자를 대상으로 12개월 간의 1b상을 시작할 계획입니다.
ProMIS Neurosciences a présenté des résultats positifs de son essai clinique de Phase 1a de PMN310, un anticorps monoclonal expérimental ciblant les oligomères toxiques de bêta-amyloïde pour la maladie d'Alzheimer, lors de la 17e conférence CTAD. L'essai, impliquant 40 volontaires sains répartis en cinq cohorts de dose (2,5-40 mg/kg), a montré que PMN310 était généralement bien toléré et traversait efficacement la barrière hémato-encéphalique. Les données pharmacocinétiques suggèrent qu'un dosage mensuel pourrait fournir des niveaux adéquats pour l'engagement avec la cible chez les patients AD. Sur la base de ces résultats, l'entreprise prévoit de lancer un essai de Phase 1b de 12 mois auprès de 100 patients présentant un léger déficit cognitif dû à AD et une AD précoce d'ici fin 2024.
ProMIS Neurosciences hat positive Ergebnisse seiner Phase-1a-Studie zu PMN310, einem experimentellen monoklonalen Antikörper, der auf toxische Beta-Amyloid-Oligomere für die Alzheimer-Krankheit abzielt, auf der 17. CTAD-Konferenz präsentiert. Die Studie umfasste 40 gesunde Freiwillige in fünf Dosisgruppen (2,5-40 mg/kg) und zeigte, dass PMN310 im Allgemeinen gut vertragen wurde und die Blut-Hirn-Schranke effektiv überquerte. Die pharmakokinetischen Daten deuten darauf hin, dass eine monatliche Dosierung angemessene Spiegel für das Target-Engagement bei AD-Patienten bieten könnte. Basierend auf diesen Ergebnissen plant das Unternehmen, bis Ende 2024 eine 12-monatige Phase-1b-Studie mit 100 Patienten mit leichter kognitiver Beeinträchtigung aufgrund von AD und früher AD zu starten.
- PMN310 demonstrated good tolerability across all five dose cohorts
- Successfully crossed blood-brain barrier in dose-dependent manner
- Pharmacokinetics support monthly dosing regimen
- Phase 1b trial advancement planned for Q4 2024
- None.
Insights
The Phase 1a trial results for PMN310 demonstrate promising safety and pharmacokinetic profiles that warrant advancement to Phase 1b testing. Key findings include:
- Successful blood-brain barrier penetration with dose-dependent characteristics
- Well-tolerated safety profile across all five dose cohorts (
2.5 to40 mg/kg ) - Monthly dosing appears sufficient for maintaining therapeutic levels
The selective targeting of toxic amyloid-beta oligomers, rather than broader amyloid-targeting approaches, represents a potentially differentiated mechanism in the AD treatment landscape. However, while these early results are encouraging, efficacy data from the upcoming Phase 1b trial in 100 AD patients will be important for validating the therapeutic potential. The planned year-end 2024 Phase 1b initiation positions potential meaningful efficacy readouts in 2025-2026.
For a small-cap biotech (
- Cash runway through the Phase 1b program
- Potential partnership discussions as positive data accumulates
- Competitive positioning against other oligomer-targeting approaches
Results indicated PMN310 was generally well-tolerated and monthly dosing can provide CSF levels adequate for target engagement
Initiation of Phase 1b clinical trial in Alzheimer’s disease patients planned for year-end 2024
CAMBRIDGE, Massachusetts and TORONTO, Ontario, Oct. 30, 2024 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (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 presented positive results from all five cohorts from the Phase 1a, single ascending dose clinical trial of its lead product candidate, PMN310, at the 17th Clinical Trials on Alzheimer’s Disease (CTAD) Conference taking place from October 29 – November 1, 2024 in Madrid, Spain.
PMN310 is an investigational humanized monoclonal antibody (mAb) designed and developed to selectively target soluble amyloid beta oligomers (AβOs), which ProMIS believes to be the most toxic and pathogenic form of Aβ, relative to Aβ monomers and amyloid plaques.
The Phase 1a clinical trial was a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability and pharmacokinetics of PMN310 in 40 healthy volunteers in the United States (NCT06105528). PMN310 was generally well-tolerated in all five single-ascending dose cohorts (2.5, 5, 10, 20 and 40 mg/kg) of the Phase 1a clinical trial and, importantly, crossed the blood brain barrier in healthy volunteers in a dose dependent manner with pharmacokinetics suggesting that monthly dosing may provide levels of PMN310 adequate for target engagement in AD patients. The complete dataset from all five cohorts reinforces previously reported data from the first four cohorts of the Phase 1a trial announced in July 2024 found here.
“We are pleased to present additional results from our first-in-human Phase 1a clinical trial of PMN310 that demonstrated PMN310 was generally well tolerated and achieved concentrations in the cerebrospinal fluid indicating its potential for target engagement in AD patients,” said Larry Altstiel, M.D., Ph.D., Chief Medical Officer of ProMIS Neurosciences. “Importantly, these results have confirmed the dosing levels for our planned 12-month, multiple ascending dose Phase 1b clinical trial in 100 patients with mild cognitive impairment due to AD and early AD, which we plan to initiate by year-end 2024. This is a significant milestone for ProMIS, and we were pleased to share our progress at this at this year’s CTAD Conference.”
Details of the poster presentation are as follows:
Title: Phase 1a Single Ascending Dose Study of PMN310, a monoclonal antibody directed against toxic Aβ oligomers
Date/Time of Presentation: Wednesday, October 30 at 3:00pm – 5:00 CET
Authors: Larry Altstiel, Johanne Kaplan, Ebrima Gibbs, Misty Lamendola, Wendy Luca, Gavin Malenfant, Mark Maginn, Yanyan Han, Neil Cashman
The abstract presentation is available on the Posters and Publications page of the Company’s website at www.promisneurosciences.com.
PMN310 builds on a large body of scientific evidence that points to the role of soluble amyloid-beta oligomers (AO) as a primary driver of Alzheimer’s disease pathology. By selectively targeting toxic oligomers, ProMIS seeks to expand therapeutic options beyond those treatments that target amyloid plaques, which it believes could provide a differentiated treatment for AD patients.
Initiation of the PMN310 Phase 1b study is planned for the fourth quarter of 2024.
About the Phase 1a Clinical Trial
The Phase 1a clinical trial was a randomized, double-blind, placebo-controlled study in 40 healthy volunteers in the United States (NCT06105528). The study consisted of five single ascending dose (SAD) cohorts and was designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of intravenous doses of PMN310. The five dosing cohorts were 2.5, 5, 10, 20 and 40 mg/kg. The decision to escalate dosing was made by a data safety monitoring board based on analysis of safety data. Serum PMN310 concentrations were collected before, and at the end of the infusion and at 0.5, 1, 2, 4, 8, 12, 24, 36, 72, 192 hours and approximately biweekly after infusion. CSF collection was done at day 3 and day 29 after dosing to determine CSF concentration of PMN310. For more information on the Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of PMN310 Infusions in Healthy Volunteers study (NCT06105528), please visit www.clinicaltrials.gov.
About PMN310
PMN310 is a humanized monoclonal antibody (mAb) designed and developed based on its selectivity for soluble amyloid beta oligomers (AβOs), which ProMIS believes are the most toxic and pathogenic form of Aβ, relative to Aβ monomers and amyloid plaque. Soluble AβOs have been observed to be potent neurotoxins that bind to neurons, inhibit synaptic function and induce neurodegeneration. By selectively targeting toxic soluble AβOs, PMN310 aims to directly address the growing body of evidence suggesting that they represent a primary underlying cause of the neurodegenerative process in Alzheimer’s disease.
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. Using this unique approach, the Company is developing novel antibody therapeutics for AD, ALS and MSA. ProMIS has offices in Cambridge, Massachusetts and Toronto, Ontario.
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, “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”, “excited to”, “targets”, “expects” or “does not expect”, “is expected”, “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 results from its Phase 1a study and the potential implications thereof, the Company's expectations regarding its clinical development of its lead product candidate, PMN310, for AD, the Company’s plans to advance into a Phase 1b multiple ascending dose study in AD patients in the fourth quarter of 2024, statements relating to the potential for such studies to provide the first proof-of-concept data for PMN310, and the potential that PMN310 has the potential to positively benefit patients with AD, 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. 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 the results of nonclinical studies and early clinical trials are not necessarily predictive of future results with PMN310, 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.
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Visit us at www.promisneurosciences.com
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For Investor Relations, please contact:
Precision AQ (formerly Stern IR)
Anne Marie Fields, Managing Director
annemarie.fields@precisionaq.com
Tel. 212-362-1200
FAQ
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