- Last patient completed the double-blind segment of
PARADIGM, a Phase 2b ALS
Trial
- Clinical efficacy top-line results from
PARADIGM expected in December
2023
CAMBRIDGE, Mass., Nov. 9, 2023
/PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN)
("NeuroSense"), a company developing treatments for severe
neurodegenerative diseases, today announced scientific
presentations at three upcoming conferences.
Neuroscience 2023
Mr. Nitai Kerem, NeuroSense's
Scientific Project Manager, will present a poster on NeuroSense's
latest biomarker data at Neuroscience 2023, the Society of
Neuroscience's annual conference. This is the largest U.S.
Neuroscience conference, bringing together scientists and
physicians devoted to understanding the brain and the nervous
system. The conference will be held in Washington D.C. on November 11th-15th,
2023.
ALS ONE's 6th Annual ALS Research Symposium
Dr. Shiran Zimri, VP of R&D at NeuroSense, will present the
Company's latest clinical updates and findings in her talk titled
"Shifting the Paradigm - A Biomarker Driven Approach for
Studying Amyotrophic Lateral Sclerosis (ALS) Therapy Activity"
at ALS ONE's 6th Annual ALS Research Symposium, to be held
virtually on November
16th-17th, and 20th 2023.
In addition to NeuroSense being a sponsor of this year's
conference, this marks the fourth year NeuroSense will present at
ALS ONE's symposium.
With a focus on the Company's Phase 2b PARADIGM PrimeC study, Dr. Zimri will present
key elements of PrimeC's development program. The last patient has
completed the double-blind segment of PARADIGM, with clinical
efficacy results (secondary endpoints)
expected in December
2023.
The 34th International Symposium on ALS/MND
Dr. Shiran Zimri and Dr. Ferenc Tracik, NeuroSense's Chief
Medical Officer, will present a poster at the 34th
International Symposium on ALS/MND, which brings together leading
ALS and motor neuron disease (MND) experts, European patient
advocacy groups, and ALS foundations, on December 6th-9th, 2023 in
Basel, Switzerland.
"We believe NeuroSense's highly innovative approach of using
biomarkers as a primary efficacy endpoint in our Phase 2b PARADIGM study will further elucidate the
biological activity of PrimeC and help us to better understand the
effect on people living with ALS," said Dr. Zimri. "We are excited
to soon begin sharing the initial results of the double-blind
segment of our Phase 2b trial to
determine our drug's impact on efficacy."
About PARADIGM
NeuroSense's Phase 2b PARADIGM
trial evaluating PrimeC's efficacy, as well as safety and
tolerability, in people living with ALS. The study is randomized 69
people living with ALS in a 2:1 ratio to receive PrimeC or placebo,
respectively. Primary endpoints of the study include assessment of
ALS biomarkers, evaluation of clinical efficacy, improvement in
quality of life, as well as safety and tolerability.
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 Company's Phase 2b trial, .
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 a delay in
the reporting of 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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