Advances novel monoclonal antibody designed to be highly selective for toxic oligomers of amyloid-beta (Aβ) in first-in-human study
TORONTO, Canada and CAMBRIDGE, MA, USA I November 20, 2023 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 announced that the Company dosed the first subjects in a first-in-human Phase 1a clinical trial of PMN310 as a potential treatment for Alzheimer’s disease (AD). PMN310 is the Company’s novel monoclonal antibody that is designed to be highly selective for toxic oligomers of amyloid-beta (Aβ), which are believed to be a major driver of AD.
“Initiation of this milestone study of PMN310 marks our transition to a clinical stage company. We are excited to bring our precision medicine approach into the clinic in hopes of developing better therapeutics for neurodegenerative diseases,” said Gail Farfel, Ph.D., Chief Executive Officer of ProMIS Neurosciences. “During the third quarter, we raised more than $20 million through a private placement financing, which meaningfully strengthens our balance sheet and supports ProMIS through potentially value-creating milestones.”
“In this Phase 1a clinical trial, we will enroll up to five cohorts of eight adult healthy volunteers, each receiving a single dose of PMN310. We expect to have initial safety and pharmacokinetic (PK) data to share in the first half of 2024. We remain committed to investigating our hypothesis that selective targeting of toxic Aβ oligomers while avoiding monomer distraction and plaque binding will potentially provide differentiation on both safety and efficacy in AD treatment response.”
“Results from the Phase 1a study will facilitate dose selection for subsequent Phase 1b study in patients with Mild Cognitive Impairment (MCI) due to AD and patients with mild AD. This study will leverage recent results from a third-party clinical study, which demonstrated that plasma and cerebrospinal fluid (CSF) efficacy biomarkers can show a treatment response in as little as three months with oligomer-focused therapy. In addition, our Phase 1b study will provide important insights into the safety profile of PMN310, which we anticipate may differentiate PMN310 from other available and potentially disease-modifying treatments.”
About the Phase 1a Clinical Trial
The study titled, “A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of PMN310 Infusions in Healthy Volunteers,” is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and PK of single ascending doses of intravenous PMN310 in healthy adult volunteers. Eligible subjects will participate in the 85-day study with one optional follow up assessment at Day 120. Primary PK data will be obtained from day 1 to day 29.
More information about the Phase 1 clinical trial can be found at www.clinicaltrials.gov or click here.
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 Toronto, Ontario and Cambridge, Massachusetts.
SOURCE: ProMIS Neurosciences
Post Views: 155
Advances novel monoclonal antibody designed to be highly selective for toxic oligomers of amyloid-beta (Aβ) in first-in-human study
TORONTO, Canada and CAMBRIDGE, MA, USA I November 20, 2023 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 announced that the Company dosed the first subjects in a first-in-human Phase 1a clinical trial of PMN310 as a potential treatment for Alzheimer’s disease (AD). PMN310 is the Company’s novel monoclonal antibody that is designed to be highly selective for toxic oligomers of amyloid-beta (Aβ), which are believed to be a major driver of AD.
“Initiation of this milestone study of PMN310 marks our transition to a clinical stage company. We are excited to bring our precision medicine approach into the clinic in hopes of developing better therapeutics for neurodegenerative diseases,” said Gail Farfel, Ph.D., Chief Executive Officer of ProMIS Neurosciences. “During the third quarter, we raised more than $20 million through a private placement financing, which meaningfully strengthens our balance sheet and supports ProMIS through potentially value-creating milestones.”
“In this Phase 1a clinical trial, we will enroll up to five cohorts of eight adult healthy volunteers, each receiving a single dose of PMN310. We expect to have initial safety and pharmacokinetic (PK) data to share in the first half of 2024. We remain committed to investigating our hypothesis that selective targeting of toxic Aβ oligomers while avoiding monomer distraction and plaque binding will potentially provide differentiation on both safety and efficacy in AD treatment response.”
“Results from the Phase 1a study will facilitate dose selection for subsequent Phase 1b study in patients with Mild Cognitive Impairment (MCI) due to AD and patients with mild AD. This study will leverage recent results from a third-party clinical study, which demonstrated that plasma and cerebrospinal fluid (CSF) efficacy biomarkers can show a treatment response in as little as three months with oligomer-focused therapy. In addition, our Phase 1b study will provide important insights into the safety profile of PMN310, which we anticipate may differentiate PMN310 from other available and potentially disease-modifying treatments.”
About the Phase 1a Clinical Trial
The study titled, “A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of PMN310 Infusions in Healthy Volunteers,” is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and PK of single ascending doses of intravenous PMN310 in healthy adult volunteers. Eligible subjects will participate in the 85-day study with one optional follow up assessment at Day 120. Primary PK data will be obtained from day 1 to day 29.
More information about the Phase 1 clinical trial can be found at www.clinicaltrials.gov or click here.
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 Toronto, Ontario and Cambridge, Massachusetts.
SOURCE: ProMIS Neurosciences
Post Views: 155
