CAMBRIDGE, Mass., May 20, 2024
/PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN)
("NeuroSense"), a company developing novel treatments for severe
neurodegenerative diseases, announces that Vice President of
R&D, Dr. Shiran Zimri will be a key presenter at the ALS Drug
Development Summit in Boston,
Mass. on May 22, 2024, which
gathers the top drug developers in the field to present findings
and collaborate toward a cure for the disease.
Dr. Zimri will present during a session titled, "Exploring the
Potentials of Combination Therapy in ALS & Showcasing Latest
Progress of PrimeC," in which she will provide an update on the
Company's latest findings from its phase 2b clinical trial (PARADIGM). Dr. Zimri will also
be leading and moderating a workshop at the pre-conference event,
which will delve into the promising field of combination therapy as
a novel approach for the treatment of ALS.
"I am thrilled to participate in and speak at this conference. I
eagerly anticipate sharing our findings and plans, engaging with
participants, and exploring new opportunities. The positive
reception from the scientific community regarding the PARADIGM
outcomes has been gratifying. We are eager to advance PrimeC to the
next stage and share our plans with regulators," stated Shiran
Zimri, NeuroSense Therapeutics VP of R&D.
More information on the ALS Drug Discovery Summit can be found
here.
Recently, the Company announced additional results of its
PARADIGM trial that included a statistically significant 43%
(p=0.02) slowing of disease progression in high-risk ALS
patients treated with PrimeC compared to placebo after 6 months.
This translates to a 5.04-point difference in ALSFRS-R scores
favoring PrimeC (CI: 0.862, 9.214; n=38) in the per protocol
population analysis.
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 by 24% by 2040 in the U.S. and EU.
About ALSFRS-R
Disease progression is measured by the ALS Functional Rating
Scale-Revised (ALSFRS-R), which is the most widely used ALS
tracking tool accepted by the FDA, utilized by neurologists
treating ALS patients, in clinical trials, and by other regulators
to determine disease progression. It tracks 12 changes in a
person's physical abilities over time including functions such as:
speech, walking, climbing stairs, dressing/hygiene, handwriting,
turning in bed, cutting food, salivation, swallowing, and
breathing. A single point change on the ALSFRS-R has a
significant impact on ALS patients, such as the transition from
independent feeding to requiring assistance or independent
breathing to needing to use a machine ventilator.
About PARADIGM
PARADIGM is a prospective, multinational,
randomized, double-blind, placebo-controlled Phase
2b (NCT05357950) clinical trial of
the Company's lead drug candidate, PrimeC, in ALS. The trial
included 68 participants living with ALS in Canada, Italy, and Israel. 96% of the trial participants who
completed the 6-month double-blind portion of the trial chose to
receive treatment with PrimeC through a 12-month open label
extension. Furthermore, to date all participants that completed the
18-month trial treatment duration, requested to continue PrimeC,
which is provided to them in an Investigator Initiated Trial, not
limited with time.
As previously reported, top-line data from the 6-month
double-blind segment of the trial showed clinically meaningful
signs of efficacy with a 29% difference in ALSFRS-R (p=0.12) and a
13% difference in SVC (p=0.5), both in favor of PrimeC vs placebo
in analysis of the intent to treat (ITT) population. These data
include all 68 people living with ALS enrolled
in Canada, Italy, and Israel, with the exclusion of
one patient who was misdiagnosed. In the PP top-line
analysis from PARADIGM, a statistically significant slowing of
disease progression was observed with a 37.4% (p=0.03) difference
in ALSFRS-R in favor of PrimeC vs placebo. Most patients enrolled
in both the active and placebo arms of the trial were concurrently
treated with Riluzole, the ALS standard of care medication,
indicating PrimeC slowed disease progression well beyond the level
afforded by the FDA approved ALS drug.
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 ALS that contribute to motor neuron degeneration, inflammation,
iron accumulation and impaired ribonucleic acid ("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 and the European Medicines Agency.
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 X.
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 a
statement regarding PrimeC as a potential treatment for people with
ALS . 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
additional results from PARADIGM clinical trial, the timing of
expected regulatory and business milestones, risks associated with
meeting with the FDA to determine the best path forward following
the results from PARADIGM clinical trial, including a delay in any
such meeting; the potential for PrimeC to safely and effectively
target ALS; preclinical and clinical data for PrimeC; the
uncertainty regarding outcomes and the timing of current and future
clinical trials; timing for reporting data; the development and
commercial potential of any product candidates of Neurosense; 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
NeuroSense is contained under the heading "Risk Factors" in the
Annual Report on Form 20-F filed with the Securities and Exchange
Commission on April 4, 2024 and
NeuroSense's subsequent filings with the SEC. Forward-looking
statements contained in this announcement are made as of this date,
and NeuroSense undertakes no duty to update such information except
as required under applicable law.
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