UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
Report of Foreign Private Issuer Pursuant to Rule 13a-16
or 15d-16
Under the Securities Exchange Act of 1934
For the Month of May 2024
Commission File Number: 001-41084
NeuroSense Therapeutics Ltd.
(Translation of registrant’s name into English)
NeuroSense Therapeutics Ltd.
11 HaMenofim Street, Building B
Herzliya 4672562 Israel
+972-9- 7996183
(Address of principal executive offices)
Indicate by check mark whether the registrant files
or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
On
May 14, 2024, NeuroSense Therapeutics Ltd. (the “Company”) issued a press release entitled “NeuroSense Partners
with PhaseV to Optimize Upcoming ALS Phase 3 Trial Using Advanced Causal Machine Learning.” A copy of the press release is furnished
herewith as Exhibit 99.1.
Exhibit Index
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
|
NeuroSense Therapeutics Ltd. |
|
|
|
Date: May 14, 2024 |
By: |
/s/ Alon Ben-Noon |
|
|
Alon Ben-Noon |
|
|
Chief Executive Officer |
2
Exhibit 99.1
NeuroSense Partners with PhaseV to Optimize
Upcoming ALS Phase 3 Trial Using Advanced
Causal Machine Learning
PhaseV’s Causal Machine Learning Predicts High Probability of Success
in Multiple ALS Subgroups for NeuroSense’s Phase 3 Trial
CAMBRIDGE, Mass., May 14, 2024 /PRNewswire/ -- NeuroSense Therapeutics
(Nasdaq: NRSN) (“NeuroSense”), a company developing novel treatments for severe neurodegenerative diseases,
today announced that it partnered with PhaseV, a pioneer in causal machine learning (ML) for clinical trial analysis and optimization,
with respect to the planned Phase 3 trial of PrimeC as a treatment for amyotrophic lateral sclerosis (ALS).
As part of the collaboration, PhaseV conducted an independent analysis
of NeuroSense’s PARADIGM Phase 2b study using a causal ML and predicts a high probability of success in multiple subgroups for the planned
Phase 3 trial of PrimeC as a treatment for ALS. The external results provide important insights that will significantly inform
study design, patient enrollment and ensure cost-effectiveness.
“There remains a critical need for new innovative approaches to
address this devastating neurodegenerative disease,” said Alon Ben-Noon, CEO of NeuroSense. “Our recently announced subgroup
analysis from the PARADIGM study is very encouraging and suggests the potential of PrimeC to change this reality. Through our initial
collaboration with PhaseV, we gained an even greater understanding of the effect of PrimeC across multiple patient subgroups. We
will apply these insights to optimize the design of our Phase 3 study with the aim of maximizing meaningful clinical results that will
differentiate PrimeC in the market. We plan to continue to collaborate with PhaseV as we develop our Phase 3 trial.”
NeuroSense Therapeutics recently reported positive efficacy and safety
data from its Phase 2b trial (PARADIGM) with its lead drug candidate for ALS, PrimeC, and is planning on embarking on a Phase 3 pivotal
trial in the next few months. In addition to PrimeC demonstrating a statistically significant 37% slowing of disease progression, as measured
by the ALSFRS-R score (p=0.03), in the per-protocol population from the PARADIGM trial, it also announced a statistically significant
slowing of disease progression in high-risk ALS patients treated with PrimeC by 43% (p=0.02) as compared
to placebo in the pre-specified per protocol (PP) population analysis after 6 months of treatment. The slowing of disease progression
demonstrated by PrimeC versus placebo translates to a 5.04 points difference in the ALSFRS-R in favor of PrimeC (Confidence Interval:
0.862, 9.214; n=38).High-risk patients, defined by the European Network for the Cure of ALS (ENCALS) Risk Factor as those with a higher
risk for rapid disease progression, comprise approximately 50% of the total ALS population.
NeuroSense soon plans to submit its End of Phase 2 package to the FDA
and EMA, including the updated Phase 3 study protocol, which will be discussed in the meetings.
“Although there is an improved understanding of the underlying
mechanisms of ALS, therapeutic options remain limited due to the complexity and heterogeneity of the disease,” said Dr. Raviv Pryluk,
CEO and Co-founder of PhaseV. “NeuroSense’s ALS drug candidate PrimeC showed great promise in its Phase 2b study. Through a unique
combination of causal-ML, real-world data, and advanced statistical methods, we confirmed the potential clinical benefit of PrimeC and
provided actionable insights for the Phase 3 study. Our analysis predicted a high rate of success for PrimeC in the Phase 3 clinical
trial for multiple recommended subgroups.”
PhaseV’s proprietary technology addresses the challenges of drug development
by providing tools for the identification of subgroups and endpoints most likely to succeed in subsequent clinical trials. This has helped
companies to better understand how their drug candidates will perform in Phase 3 clinical trials and to optimize the design of the Phase
3 trial accordingly in order to achieve meaningful and successful outcomes.
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, with a primary focus on ALS.
For additional information, we invite you to visit our website and
follow us on LinkedIn.
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 benefits of the collaboration with Phase V and the timing
for a planned End of Phase 2 meeting with the FDA and EMA. 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 the risk that the collaboration
with Phase V will not bring the expected benefits; 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; 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 NeuroSense Therapeutics 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 Therapeutics’ subsequent filings with the
SEC. 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.
Logo - https://mma.prnewswire.com/media/1707291/NeuroSense_Therapeutics_Logo.jpg
NeuroSense Therapeutics (NASDAQ:NRSNW)
Historical Stock Chart
From May 2024 to Jun 2024
NeuroSense Therapeutics (NASDAQ:NRSNW)
Historical Stock Chart
From Jun 2023 to Jun 2024