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.
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