Data to be announced in a premarket press release
followed by a conference call at 8:30 am
ET
CAMBRIDGE, Mass., Dec. 4, 2023
/PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN)
("NeuroSense"), a company developing treatments for
neurodegenerative diseases, today announced it will report new data
from the randomized, placebo-controlled, double-blind segment of
its ongoing Phase 2b amyotrophic
lateral sclerosis (ALS) trial (PARADIGM) of its lead drug candidate
PrimeC. The data will include primary safety and tolerability
endpoints as well as secondary clinical efficacy outcome measures:
Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised
(ALSFRS-R) and Slow Vital Capacity (SVC).
To join the conference call via phone and participate in the
live Q&A session, please pre-register online here to
receive a telephone number and unique passcode required to enter
the call. The live webcast and audio archive of the presentation
may be accessed on the investor section of NeuroSense's website
at https://neurosense.investorroom.com/. The webcast will be
available for replay for 30 days.
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 amyotrophic lateral sclerosis (ALS) that contribute to motor
neuron degeneration, inflammation, iron accumulation and impaired
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 (FDA) and the European Medicines
Agency (EMA).
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 and
X, formerly known as 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 the timing for release of results
from the double-blind segment of the Company's Phase 2b trial, the timing for release of results from
the Company's strategic collaboration with Biogen, the timing for
release of additional results from PARADIGM clinical trial, the
cash runway of the Company, the timing of a Phase 2 trial for
Alzheimer's disease and patient enrollment regarding a Phase 3
pivotal ALS trial of PrimeC. 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,
a delay in the reporting of clinical top-line results from PARADIGM
clinical trial, a delay in patient enrollment for a Phase 2 trial
for Alzheimer's disease or its 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 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 March
22, 2023. 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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SOURCE NeuroSense