Full Press Release Details
ProMIS Neurosciences
Doses First Subjects in Phase 1a Clinical Trial of PMN310 to Treat Alzheimer's Disease
Advances novel monoclonal antibody designed
to be highly selective for toxic oligomers of amyloid-beta (A ) in first-in-human study
TORONTO, Ontario and CAMBRIDGE, Massachusetts - November 20,
2023 - 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 (A ), which are believed to be a major driver
"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."
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 A 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.
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",
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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 planned timing for completion and anticipated data readout of the
Phase 1a clinical trial and the anticipated use of proceeds from the private placement. 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 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
information form available on www.SEDAR.com, in Item 1A of its Annual Report on Form 10-K for the year ended December 31, 2022 and the
section entitled "Risk Factors" in its Post-Effective Amendment No. 1 to Form S-1, filed March 17, 2023, each as filed with
the Securities and Exchange Commission, and subsequent quarterly reports. 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
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Anne Marie Field, Managing Director