Full Press Release Details
NeuroSense Vice President of R&D Shiran
Zimri, Ph.D. to Participate in
the 3rd Annual ALS Drug Development Summit
Mass., May 20, 2024, -- 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
"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
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.
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.
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.
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.
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.
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.
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.
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
Email: info@neurosense-tx.com, Tel: +972 (0)9