Full Press Release Details
NeuroSense Demonstrates Statistically Significant
Survival Benefits in People Living with ALS:
The Promising Results from the 12-Month PARADIGM
PrimeC's Potential as a Disease Modifying Drug
Mass., July 1, 2024, -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a late-clinical stage biotechnology
company developing novel treatments for severe neurodegenerative diseases, today reported statistically significant results from the
12-month data analysis of the PARADIGM Phase 2b study evaluating PrimeC in people living with Amyotrophic Lateral Sclerosis (ALS).
The data show a significant improvement
in the rate of decline of ALS Functional Rating Scale-Revised (ALSFRS-R) scores and survival rates for subjects who received PrimeC from
the start of the trial compared to those who started on placebo. Specifically, the intent to treat (ITT) analysis of the study at 12 months
revealed a difference of 6.5 points in the ALSFRS-R, which represents a 36% improvement and a highly statistically significant P value
In addition, at 12 months participants on PrimeC demonstrated better survival than those initially on placebo, by 43%.
In an additional pre-defined
analysis of the Per-Protocol Population at 12 months, the results showed an even greater effect, with a difference of approximately 7.7
points (p=0.003) between the groups, translating to more than 40% improvement for participants who received PrimeC from the start compared
to those on placebo. Furthermore, this analysis indicated that the survival rate of participants on PrimeC improved by 63% compared to
participants who received a placebo.
"These exciting long-term
results demonstrate how study participants experienced more slowing of progression over time with PrimeC as measured against ALSFRS-R,
which is the current gold-standard scale used in ALS drug development," said Merit Cudkowicz, M.D., M.Sc., chair of neurology and
Director of the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital. "The need for new treatments for people
living with ALS has never been greater. PrimeC has great potential based on its mode of action and the phase 2 trial results and warrants
further evaluation in a Phase 3 trial in an expeditious manner".
MD, Head of the ALS clinic at Tel-Aviv Sourasky Medical Center added: "The promising results from the 12-month PARADIGM study highlight
the significant potential of PrimeC as a disease-modifying drug for ALS. These findings underscore the importance of early intervention,
which can lead to more substantial benefits, and provide valuable insights that will inform the design of the Company's Phase 3
study, increasing the likelihood of success."
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 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1
billion. The number of people living 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 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
(June 2024) 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, in the 6-month double-blind segment of the trial, the data showed clinically meaningful signs of efficacy with a 29% difference
in favor of PrimeC vs placebo in analysis of the intent to treat (ITT) population. 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.
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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 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; the ability of NeuroSense to remain listed on Nasdaq; 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.
information: Email: info@neurosense-tx.com, Tel: +972 (0)9 799 6183