- PARADIGM protocol is approved in four countries:
Israel, Italy, Canada, and Germany
- Topline results expected in H2 2023
CAMBRIDGE, Mass., Feb. 8, 2023
/PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN)
("NeuroSense"), a company developing treatments for severe
neurodegenerative diseases, today announced that Germany's Federal Institute for Drugs and
Medical Devices (BfArM) approved the Company's Clinical Trial
Application (CTA) to enroll patients in PARADIGM, its Phase
2b study of its lead combination drug
candidate PrimeC in the treatment of amyotrophic lateral sclerosis
(ALS).
PARADIGM is a Phase 2b randomized,
multi-center, multinational, prospective, double-blind,
placebo-controlled study, with an open-label extension, to evaluate
the safety, tolerability, and efficacy of PrimeC. To date, over 50%
of the planned 69 study participants have been enrolled.
"We expect to enroll the first study participant in Germany in the next few weeks, and we are very
pleased to receive regulatory clearance to enroll and dose people
living with ALS also in Germany
for our PARADIGM study," stated NeuroSense's Chief Medical Officer,
Dr. Ferenc Tracik. "We are currently
on track to complete enrollment and report data in the second half
of this year."
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 study which
successfully 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. Through a collaboration with
Massachusetts General Hospital in Boston on novel
Neuron-Derived Exosomes (NDEs), NeuroSense is working to further
determine the biological changes in ALS-related pathologies and the
effect of PrimeC on relevant targets. PrimeC was granted
Orphan Drug Designation by the U.S. Food and Drug Administration
(FDA) and the European Medicines Agency (EMA).
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 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 patent applications; the company's PrimeC
development program; the potential for PrimeC to safely and
effectively target ALS; preclinical and clinical data for PrimeC;
the timing of current and future clinical trials; the nature,
strategy and focus of the company and further updates with respect
thereto; and the development and commercial potential of any
product candidates of the company. Further, certain forward-looking
statements are based on assumptions as to future events that may
not prove to be accurate. Such risks and uncertainties include the
risk that there will a delay in the timing of the enrollment of the
study participants in, and the report of topline results of, the
PARADIGM study and other risks and uncertainties set forth in the
Company's filings with the Securities and Exchange Commission
(SEC), including the Company's Annual Report on Form 20-F filed
with the SEC on April 14, 2022.
Further, certain forward-looking statements are based on
assumptions as to future events that may not prove to be accurate.
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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SOURCE NeuroSense