Full Press Release Details
NeuroSense Therapeutics Plans to File for Early Commercialization of ALS Treatment in Canada
CAMBRIDGE, Mass., Oct. 9,
2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense" or the "Company"), a late-clinical
stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced it has initiated the
regulatory process to seek early commercialization approval for PrimeC under Health Canada's Notice of Compliance with
Conditions (NOC/c) policy. This submission is based on the promising results from the Company's Phase 2b ALS PARADIGM clinical
trial, alongside supporting clinical and preclinical data.
This decision aligns with the
recommendations of Canadian regulatory experts and follows recent clinical findings, where PrimeC demonstrated a 36% reduction in
disease progression (p=0.009) and a 43% improvement in survival rates compared to placebo, underscoring its
potential as a breakthrough therapy for ALS.
Alon Ben-Noon, NeuroSense CEO expressed optimism about the Company's
prospects: "We are excited to take this important step toward bringing PrimeC to ALS patients in Canada. The compelling results from
our clinical trials give us confidence that PrimeC can address the urgent unmet needs in ALS treatment. Our goal is to expedite access
to this promising therapy, and we are committed to advancing regulatory approvals in Canada and beyond."
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.
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.
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.
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.
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
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 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
the risk that regulatory approvals for PrimeC will not be obtained in Canada or elsewhere; 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.
For further information: Email: info@neurosense-tx.com, Tel: +972