- The preparations for the regulatory submission for early
commercialization in Canada
follows the positive Phase 2b trial
results which show PrimeC reduces ALS disease progression by 36%
and improves survival rates by 43%
- Company plans to seek approval in additional
countries
CAMBRIDGE, Mass., Oct. 9, 2024
/PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN)
('NeuroSense'), 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."
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 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.
About ALSFRS-R
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.
About PARADIGM
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.
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 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.
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,
YouTube and X. Information that may be important to
investors may be routinely posted on our 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.
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