Full Press Release Details
NeuroSense Receives FDA Clearance of IND for
its ALS Phase 2b Study
CAMBRIDGE, Mass., Nov. 15, 2022 /PRNewswire/ -- NeuroSense
Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today
announced the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) to enroll patients in the
U.S. for its Phase 2b PARADIGM study for its lead drug candidate PrimeC in the treatment of amyotrophic lateral sclerosis (ALS).
PARADIGM is currently enrolling patients in Israel, and NeuroSense expects to open clinical sites for patient recruitment in the European
Union in the coming weeks. PrimeC has Orphan Drug Designation with the FDA and the European Medicines Agency (EMA).
As a combination therapy of two FDA approved drugs with well-established
safety profiles, PrimeC is designed to synergistically target several key ALS mechanisms that contribute to motor neuron degeneration,
inflammation, iron accumulation, and impaired RNA regulation to potentially inhibit the progression of ALS.
PARADIGM, (NCT05357950), a Phase 2b double-blind, placebo-controlled,
multinational clinical trial, aims to assess PrimeC's efficacy, as well as safety and tolerability, in people living with ALS. The study
is enrolling and randomizing 69 people living with ALS in a 2:1 ratio to receive PrimeC or placebo, respectively. Study participants will
be allowed to administer standard of care (SOC) treatment of approved products. Primary and secondary endpoints of the study include assessment
of ALS-biomarkers, evaluation of clinical efficacy, and improvement in quality of life. All subjects who complete the 6 month double-blind,
placebo-controlled dosing period will be switched to the PrimeC active arm for a 12-month open label extension.
NeuroSense expects to enroll and dose the first U.S. patients in the
next few weeks at leading ALS centers on both the east and west coast.
"FDA's acceptance of our IND paves the way for NeuroSense to commence
patient enrollment in the U.S. and is another significant milestone achieved in our drug development plan," stated NeuroSense CEO
Alon Ben-Noon. "This clinical trial is evaluating our new and improved extended release formulation of PrimeC, which may provide
a better outcome than already observed in our prior Phase 2a study. We are pleased to offer PrimeC to patients who are eager to take part
in the clinical program, and we look forward to completing enrollment and announcing results in the next several months - Mid 2023."
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).
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.
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
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. 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.
For further information: Email: info@neurosense-tx.com, Tel: +972 (0)9