CAMBRIDGE, Mass., May 2, 2024
/PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN)
("NeuroSense"), a company developing novel treatments for severe
neurodegenerative diseases, today provides a business update.
Corporate Highlights from Q1 2024 and To Date
- Merit Cudkowicz, M.D., M.Sc., chair of neurology and
Director of the Sean M. Healey & AMG Center for ALS at
Massachusetts General Hospital presented full data update from
PARADIGM in ALS during Emerging Sciences (late-breaker equivalent)
presentation at the American Academy of Neurology annual
meeting
- Announced collaboration with Genetika+ to apply their
precision medicine methodology to better quantify neuronal
plasticity as part of the Company's ongoing Phase 2 Alzheimer's
disease trial
- Entered into collaboration with Lonza (SIX: LONN) to
identify exosome-based biomarkers to further advance PrimeC in
ALS
- Company announced subsequent analyses of quality of life and
complication free survival from the PARADIGM Study, which
demonstrated positive results as well as positive trends of key
biomarker outcome of neurofilament light chain (NfL) levels
"The first several months of 2024 have proven to be very
productive for NeuroSense as we have entered into multiple key
collaborations that we expect will help to enhance the development
of PrimeC both for ALS and Alzheimer's disease. In addition, our
PARADIGM results received significant validation when they were
accepted as late breaking data at the AAN conference," stated
NeuroSense CEO Alon Ben-Noon. "We
were honored to have Dr. Merit Cudkowicz present the data to a
wide scientific audience, and we believe that these data will
continue to be welcomed in the medical community as providing
encouragement in the search for viable ALS treatment."
"As we proceed through the second quarter, we anticipate further
collaborations as well as to schedule an end of Phase 2 study with
FDA in order to continue this important research into a Phase 3
clinical trial. We look forward to providing additional new data
from the PARADIGM trial," concluded Mr. Ben-Noon.
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
patients are diagnosed with ALS in the U.S. alone, with an annual
disease burden of $1 billion. The number of patients with ALS
is expected to grow 24% by 2040 in the U.S. and EU.
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
the 6-month double blind portion of PARADIGM, a prospective,
multinational, randomized, double-blind, placebo-controlled
Phase 2b ALS (NCT05357950) clinical trial, which
met its safety and tolerability endpoints, as well as showing a
statistically significant slowing of disease progression in the
pre-specified Per Protocol (PP) population. 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.
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 NeuroSense's collaborations and
PrimeC as a potential treatment for people with ALS and the timing
for release of additional results from PARADIGM clinical trial.
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
that NeuroSense will not enter into other collaborations, that the
existing collaborations will not will help to enhance the
development of PrimeC, unexpected R&D costs or operating
expenses, unanticipated reactions in the medical community to the
results of the PARADIGM clinical trial, a delay in the reporting of
additional results from PARADIGM clinical trial, the timing of
expected regulatory and business milestones, including an end of
Phase 2 study with FDA, 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 in the planned Phase 3 pivotal ALS
trial of PrimeC; 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 the company; the
ability to regain compliance with Nasdaq's continued listing
standards; 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
3, 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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