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, MA, USA and TORONTO, Canada I October 30, 2024 I 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 (AbO) 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.
SOURCE: ProMIS Neurosciences
Post Views: 2,159
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, MA, USA and TORONTO, Canada I October 30, 2024 I 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 (AbO) 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.
SOURCE: ProMIS Neurosciences
Post Views: 2,159
