- In participants who received PrimeC from the start
of the 18-month study compared to those initially on placebo before
transitioning to PrimeC, disease progression was slowed by 33%
(p=0.007), demonstrated in a 58% improvement in
survival rates
- Consistent data across subgroups underscore the potential
of PrimeC to redefine the standard of care in the treatment of
ALS
CAMBRIDGE, Mass., Dec. 4, 2024
/PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN)
("NeuroSense"), a late-clinical stage biotechnology company
developing novel treatments for severe neurodegenerative
diseases, is pleased to announce today statistically
significant positive results from the 18-month data analysis of the
PARADIGM study, evaluating the efficacy of PrimeC in the treatment
of Amyotrophic Lateral Sclerosis (ALS). These results highlight a
significant improvement in ALS Functional Rating Scale-Revised
(ALSFRS-R) scores and survival rates for patients receiving PrimeC
from the start compared to those who started on placebo.
The study revealed a significant difference of nearly
8
points in ALSFRS-R between the group treated with PrimeC for 18
months and the group that received placebo for 6 months before
transitioning to PrimeC for 12 months. This difference seen between
the groups represents a
33% functional improvement, with a
highly significant
P value of 0.007. In addition, patients
on PrimeC for 18 months demonstrated a significantly better
survival outcome than those initially on placebo, with a
58%
improvement in survival rates.
The 18-month PARADIGM study results will be presented at the
2024 International Symposium on ALS/MND, taking place December 6-8, 2024, in Montreal, Canada, by Prof. Merit Cudkowicz,
Chair of Neurology at Massachusetts General Hospital, Director of
the Sean M. Healey & AMG Center for ALS, and the Julieanne Dorn
Professor of Neurology at Harvard Medical
School. Prof. Cudkowicz is a world-renowned leader in ALS
research, whose insights into PrimeC's potential to improve patient
outcomes are highly anticipated.
Additional results will be shared in due course.
The Company anticipates to update on the outcome of the meeting
with the FDA in the next several 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 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.
As previously reported, in the 12 months readout, the study
revealed a remarkable difference of 6.5 points in the ALS
Functional Rating Scale-Revised (ALSFRS-R) between the group
treated with PrimeC for 12 months and the group that received
placebo for 6 months before transitioning to PrimeC. This
represents a 36% improvement, with a highly significant P value of
0.009. These outcomes mark the best results ever achieved in ALS
clinical research.
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 the timing of regulatory filings, meetings and
regulatory decisions. 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 of a delay in submission by the Company of
its regulatory dossier, that regulatory approvals for PrimeC
will be delayed or not 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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