CAMBRIDGE, Mass., Nov. 21,
2024 /PRNewswire/ -- NeuroSense Therapeutics
Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-clinical stage
biotechnology company developing novel treatments for severe
neurodegenerative diseases, is pleased to announce its
participation in the 2024 International Symposium on ALS/MND, to be
held December 6-8, 2024, in
Montreal, Canada.
During the event, NeuroSense will present the latest findings
from its Phase 2b PARADIGM trial of
PrimeC, a potential treatment for Amyotrophic Lateral Sclerosis
(ALS).
Key Presentations at the Symposium:
- Prof. Merit Cudkowicz, Chair of Neurology at
Massachusetts General Hospital, Director of the Sean M. Healey
& AMG Center for ALS, and the Julieanne Dorn Professor of
Neurology at Harvard Medical School,
will present the latest clinical outcomes from the PARADIGM trial.
As a globally recognized leader in ALS research, Prof. Cudkowicz's
insights into PrimeC's potential to improve patient outcomes are
highly anticipated.
- Dr. Cristian Lunetta, a
renowned neurologist and Director of Department of Neuromotor
Rehabilitation and ALS Unit
of Istituti Clinici Scientifici Maugeri IRCCS, Milan, Italy, will share an in-depth analysis
of biomarkers from the PARADIGM trial. This data provides critical
insights into PrimeC's mechanism of action, offering a potential
breakthrough in ALS treatment strategies.
Additionally, the NeuroSense management team, including
Alon Ben-Noon, CEO, Dr.
Ferenc Tracik, CMO, Hagit
Binder, COO, and Dr. Shiran Zimri, VP of R&D,
will be in attendance. Their participation underscores NeuroSense's
leadership in advancing ALS research and its commitment to shaping
the future of neurodegenerative disease therapies.
The ALS/MND Symposium is the premier global forum for ALS
research, bringing together world-leading scientists, clinicians,
and experts to discuss the latest advancements in the field.
NeuroSense's involvement highlights its dedication to addressing
the unmet needs of ALS patients through pioneering clinical trials
and innovative biomarker research.
For additional information about the symposium and NeuroSense's
presentations, please visit https://www.neurosense-tx.com/.
About ALS
Amyotrophic lateral sclerosis ("ALS") is an incurable
neurodegenerative disease that causes complete paralysis and death
within 2-5 years from diagnosis. Every year, more than 5,000 people
are diagnosed with ALS in the U.S. alone, with an annual disease
burden of $1 billion. The number of people living with ALS is
expected to grow by 24% by 2040 in the U.S. and EU.
About ALSFRS-R
Disease progression is measured by the ALS Functional Rating
Scale-Revised (ALSFRS-R), which is the most widely used ALS
tracking tool accepted by the FDA, utilized by neurologists
treating ALS patients, in clinical trials, and by other regulators
to determine disease progression. It tracks 12 changes in a
person's physical abilities over time including functions such as:
speech, walking, climbing stairs, dressing/hygiene, handwriting,
turning in bed, cutting food, salivation, swallowing, and
breathing. A single point change on the ALSFRS-R has a
significant impact on ALS patients, such as the transition from
independent feeding to requiring assistance or independent
breathing to needing to use a machine ventilator.
About PARADIGM
PARADIGM is a prospective, multinational,
randomized, double-blind, placebo-controlled Phase
2b (NCT05357950) clinical trial of
PrimeC in ALS. The trial included 68 participants living with ALS
in Canada, Italy, and Israel. 96% of the trial participants who
completed the 6-month double-blind portion of the trial chose to
receive treatment with PrimeC through a 12-month open label
extension. Furthermore, to date (June
2024) all participants that completed the 18-month trial
treatment duration, requested to continue PrimeC, which is provided
to them in an Investigator Initiated Trial, not limited with
time.
As previously reported, in the 6-month double-blind segment of
the trial, the data showed clinically meaningful signs of efficacy
with a 29% difference in favor of PrimeC vs placebo in analysis of
the intent to treat (ITT) population. In the PP top-line
analysis from PARADIGM, a statistically significant slowing of
disease progression was observed with a 37.4% (p=0.03) difference
in ALSFRS-R in favor of PrimeC vs placebo. Most patients enrolled
in both the active and placebo arms of the trial were concurrently
treated with Riluzole, the ALS standard of care medication,
indicating PrimeC slowed disease progression well beyond the level
afforded by the FDA approved ALS drug.
About PrimeC
PrimeC, NeuroSense's lead drug candidate, is a novel
extended-release oral formulation composed of a unique fixed-dose
combination of two FDA-approved drugs: ciprofloxacin and celecoxib.
PrimeC is designed to synergistically target several key mechanisms
of ALS that contribute to motor neuron degeneration, inflammation,
iron accumulation and impaired ribonucleic acid ("RNA") regulation
to potentially inhibit the progression of ALS. NeuroSense completed
a Phase 2a clinical trial which met its safety and efficacy
endpoints including reducing functional and respiratory
deterioration and statistically significant changes in ALS-related
biological markers indicating PrimeC's biological activity. PrimeC
was granted Orphan Drug Designation by the U.S. Food and Drug
Administration and the European Medicines Agency.
About NeuroSense
NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology
company focused on discovering and developing treatments for
patients suffering from debilitating neurodegenerative diseases.
NeuroSense believes that these diseases, which include amyotrophic
lateral sclerosis (ALS), Alzheimer's disease and Parkinson's
disease, among others, represent one of the most significant unmet
medical needs of our time, with limited effective therapeutic
options available for patients to date. Due to the complexity of
neurodegenerative diseases and based on strong scientific research
on a large panel of related biomarkers, NeuroSense's strategy is to
develop combined therapies targeting multiple pathways associated
with these diseases.
For additional information, we invite you to visit
our website and follow us on LinkedIn,
YouTube and X. Information that may be important to
investors may be routinely posted on our website and these social
media channels.
Forward-Looking Statements
This press release contains "forward-looking statements" that
are subject to substantial risks and uncertainties. All statements,
other than statements of historical fact, contained in this press
release are forward-looking statements. Forward-looking statements
contained in this press release may be identified by the use of
words such as "anticipate," "believe," "contemplate," "could,"
"estimate," "expect," "intend," "seek," "may," "might," "plan,"
"potential," "predict," "project," "target," "aim," "should,"
"will" "would," or the negative of these words or other similar
expressions, although not all forward-looking statements contain
these words. Forward-looking statements are based on NeuroSense
Therapeutics' current expectations and are subject to inherent
uncertainties, risks and assumptions that are difficult to predict
and include statements regarding the timing of regulatory filings
and regulatory decisions, the market opportunity in Canada and securing regulatory approval in
global markets. Further, certain forward-looking statements are
based on assumptions as to future events that may not prove to be
accurate. The future events and trends may not occur and actual
results could differ materially and adversely from those
anticipated or implied in the forward looking statements. These
risks include the risk of a delay in submission by the Company of
its regulatory dossier, that regulatory approvals for PrimeC
will be delayed or not obtained in Canada or elsewhere; that the market
opportunity in Canada will not be
as currently estimated; unexpected R&D costs or operating
expenses, insufficient capital to complete development of PrimeC, a
delay in the reporting of additional results from PARADIGM clinical
trial, the timing of expected regulatory and business milestones,
risks associated with meeting with the FDA and Health Canada to
determine the best path forward following the results from PARADIGM
clinical trial, including a delay in any such meeting; the
potential for PrimeC to safely and effectively target ALS;
preclinical and clinical data for PrimeC; the uncertainty regarding
outcomes and the timing of current and future clinical trials;
timing for reporting data; the development and commercial potential
of any product candidates of NeuroSense; the ability of NeuroSense to remain
listed on Nasdaq; and other risks and uncertainties set forth in
NeuroSense's filings with the Securities and Exchange Commission
(SEC). You should not rely on these statements as representing our
views in the future. More information about the risks and
uncertainties affecting NeuroSense is contained under the heading
"Risk Factors" in the Annual Report on Form 20-F filed with the
Securities and Exchange Commission on April
4, 2024 and NeuroSense's subsequent filings with the SEC.
Forward-looking statements contained in this announcement are made
as of this date, and NeuroSense undertakes no duty to update such
information except as required under applicable law.
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