Full Press Release Details
NeuroSense to Report Phase 2b ALS Topline Primary Safety and Tolerability & Secondary Clinical Efficacy Endpoints on December 5, 2023
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.
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
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).
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
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.
For further information: Email: info@neurosense-tx.com, Tel: +972 (0)9