- Clinical efficacy top-line results of PARADIGM, a Phase
2b trial in ALS, expected in
December 2023
CAMBRIDGE, Mass., Nov. 13,
2023 /PRNewswire/ -- NeuroSense Therapeutics Ltd.
(NASDAQ: NRSN) ("NeuroSense"), a company developing treatments for
severe neurodegenerative diseases, today announced it has concluded
a successful Type D meeting with the U.S. Food and Drug
Administration (FDA) for PrimeC in the treatment of amyotrophic
lateral sclerosis (ALS). FDA Type D meetings are focused on a
narrow set of issues at key decision points to provide timely
feedback critical to move a drug development program forward. The
purpose of NeuroSense's meeting with the FDA was to discuss
PrimeC's chemistry, manufacturing, and controls (CMC) development
plans in advance of an expected Phase 3 pivotal study and potential
subsequent marketing approval. The FDA agreed with NeuroSense's
proposed CMC development plan. PrimeC has already been granted
Orphan Drug Designation by the FDA and the European Medicines
Agency (EMA).
"This confirmation from the FDA of our CMC strategy for a future
pivotal Phase 3 clinical trial and commercial launch of PrimeC in
the treatment of ALS marks a critical milestone in our drug
development program. It sets the stage for a smooth transition,
particularly as we anticipate clinical efficacy top-line results
(secondary endpoints) from our Phase 2b trial very soon," stated Alon Ben-Noon, CEO of NeuroSense.
NeuroSense is currently conducting PARADIGM (NCT05357950), a
multinational, randomized, double-blind, placebo-controlled Phase
2b clinical trial of PrimeC in ALS.
Sixty-nine people living with ALS in Canada, Italy, and Israel have been enrolled into PARADIGM, which
aims to assess PrimeC's efficacy, as well as safety and
tolerability. Primary and secondary endpoints of the study include
assessment of ALS-biomarkers, evaluation of clinical efficacy, and
improvement in quality of life. In the double-blind segment 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.
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.
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 and regarding an expected Phase 3
pivotal study. 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 a delay in the reporting of clinical
top-line results from PARADIGM clinical trial, the failure to meet
the primary or secondary endpoints of the 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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