Presentation by Massachusetts General Chair
of Neurology Merit Cudkowicz, MD, shows both positive clinical
effects and consistent trend toward impact on Neurofilament
biomarker levels
CAMBRIDGE, Mass., April 18,
2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd.
(NASDAQ: NRSN) ("NeuroSense"), a company developing novel
treatments for severe neurodegenerative diseases, announces
the presentation of data from the Company's PARADIGM Phase
2b study of PrimeC during an Emerging
Science session (equivalent to Late Breaker) at the American
Academy of Neurology Annual Meeting, which validates the previously
announced topline data. In addition to the positive clinical
outcomes, the study also demonstrated a positive trend toward
impact on Neurofilament (NfL) levels.
The presentation, titled, "PrimeC, An Oral Candidate for
Amyotrophic Lateral Sclerosis, Meets Primary and Secondary
Endpoints in the Phase 2b PARADIGM
Trial," was presented yesterday as an Emerging Science presentation
by Merit Cudkowicz, M.D., M.Sc., chair of neurology and Director of
the Sean M. Healey & AMG Center for ALS at Massachusetts
General Hospital. The study showed that PrimeC, a novel
formulation of specific doses of ciprofloxacin and celecoxib, met
safety and tolerability measures as well as statistically
significant slowing of disease progression as demonstrated by the
ALSFRS-R by 37% (p=0.03) in the per-protocol population.
Further, the data showed supporting trends in biomarkers,
specifically Neurofilament.
Alon Ben-Noon, CEO of NeuroSense
commented, "It is gratifying that these data have been validated by
the prestigious American Academy of Neurology and presented by Dr.
Cudkowicz. We look forward to continued work with PrimeC for
ALS and believe that there is a significant opportunity to provide
a potential new approach to address this devastating disease."
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, please visit the Company's
website and follow NeuroSense on LinkedIn and X
(Twitter).
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 PrimeC as a potential treatment
for people with ALS. 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 unexpected R&D costs or operating expenses, the
timing of expected regulatory and business milestones, inability to
retain the listing of the Company's ordinary share on Nasdaq, risks
associated with meeting with the FDA to determine the best path
forward following the results from PARADIGM clinical trial,
including a delay in any such meeting, a delay in patient
enrollment for a Phase 2 trial for Alzheimer's disease; the
potential for PrimeC to safely and effectively target AD;
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 the company; 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 the Company
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. Forward-looking
statements contained in this announcement are made as of this date,
and NeuroSense Therapeutics Ltd. undertakes no duty to update such
information except as required under applicable law.
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