- Clinical efficacy results
(secondary endpoints) and safety
results (primary endpoints) expected December 2023
- Biogen collaboration biomarker results expected Q1
2024
- Primary biomarker endpoints to be reported H1
2024
CAMBRIDGE, Mass., Nov. 6, 2023
/PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN)
("NeuroSense"), a company developing treatments for severe
neurodegenerative diseases, today announced it has completed dosing
of the last patient in the double-blind segment of its Phase
2b amyotrophic lateral sclerosis
(ALS) trial of PrimeC (PARADIGM). PrimeC is designed to
synergistically target several key ALS mechanisms that contribute
to motor neuron degeneration, inflammation, iron accumulation, and
impaired RNA regulation to inhibit the progression of ALS. PrimeC
has been granted Orphan Drug Designation from the U.S. Food and
Drug Administration (FDA) and the European Medicines Agency
(EMA).
Sixty-nine people living with ALS in Canada, Italy, and Israel were enrolled in the double-blind
segment of PARADIGM (NCT05357950), a multinational, randomized,
double-blind, placebo-controlled Phase 2b clinical trial of PrimeC in ALS, wherein trial
participants were dosed for 6 months after being randomized 2:1 to
receive PrimeC or placebo, respectively. After completion of the
double-blind segment, the participants had the option to enroll in
a 12-month open label extension (OLE), during which they all
receive treatment with PrimeC. 96% of the participants chose to
continue into the OLE.
The Company expects to release clinical efficacy results
(secondary endpoints) from the double-blind segment of the trial in
December 2023. These secondary
endpoints include clinical outcome measures: Amyotrophic Lateral
Sclerosis Functional Rating Scale-Revised (ALSFRS-R), Slow Vital
Capacity (SVC), quality of life and overall survival. ALSFRS-R is
recognized and widely used as an endpoint in ALS clinical trials
that are evaluated by the FDA. This scale aids in providing a
measurement of the impact of the disease on various functional
activities and the overall quality of life of patients with ALS.
The Company also expects to report the safety and tolerability
results (primary endpoints) of the double-blind segment of the
trial in December 2023.
The Company expects to report on another primary endpoint, the
assessment of ALS-biomarkers, TDP-43 and Prostagladin2, to evaluate
PrimeC's biological activity, in H1 2024 following the completion
of the ongoing analysis of patients' plasma. PrimeC was previously
observed to have a statistically significant impact in TDP-43 and
Prostagladin2, in NeuroSense's previous Phase 2a trial.
Additionally, in the first quarter of 2024, the Company expects
to report results from a strategic collaboration with Biogen that
is evaluating the impact of PrimeC on patients enrolled in
PARADIGM. Under this collaboration, Biogen is to meaningful
biomarker analysis and upon receipt of results, has the right of
first refusal to co- fund this develop/commercialize PrimeC for the
treatment of ALS for a limited time following the
results.
Recent findings from independent studies at the University of Southern California showed PrimeC
significantly increased the survival rate of induced motor neurons
in an in vitro ALS study and PrimeC performed among
the best in improving motor neuron survival when compared to
several other ALS drugs in development and two U.S. FDA approved
ALS drugs.
"We are excited to soon begin sharing the results of the
double-blind segment of our Phase 2b
trial," stated Alon Ben Noon, CEO of
NeuroSense. "We would like to thank the trial participants, their
caregivers and families, as well as the sites' Principal
Investigators and study coordinators for their tremendous
contribution to PARADIGM."
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 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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