CAMBRIDGE, Mass., April 22,
2024 /PRNewswire/ -- NeuroSense Therapeutics
Ltd. (NASDAQ: NRSN) ("NeuroSense"), a company developing novel
treatments for severe neurodegenerative diseases announced today a
collaboration in Alzheimer's Disease (AD) drug development with
Genetika+, a leader in precision medicine for psychiatry and
neurology. The multi-phase collaboration, which will commence in
NeuroSense's currently ongoing Phase 2 AD clinical
trial, leverages Genetika+'s state-of-the-art technology that
derives frontal cortex neurons from individual patients' blood to
quantify drug-induced neuronal plasticity in vitro.
The Genetika+ technology serves as a human AD disease model
and will be used to correlate clinical response with cellular
effects, for mechanistic drug insights and patient subset
identification, supporting drug development and potentially
commercialization. This collaboration addresses key challenges in
the development of drugs for AD, by promoting disease and drug
mechanistic understanding, increasing the likelihood of success of
AD drug development, and enabling the realization of precision
medicine approaches.
"We believe Genetika+'s technology presents a unique opportunity
to optimize our current ongoing trial. It harmonizes seamlessly
with our evaluation of our combination drug therapy through
clinical assessments and an extensive array of biomarkers," stated
Dr. Shiran Zimri, VP of R&D at NeuroSense. "There are
significant opportunities to harness cutting-edge advancements in
AD therapeutic research and these are crucial for the future of
early detection and treatment of neurodegenerative
conditions."
Distinguished by its innovative approach, NeuroSense's PrimeC
therapy stands out in the landscape of AD treatments. Unlike
conventional methods that predominantly target amyloid-beta (Aβ),
PrimeC adopts a multi-targeted strategy, concurrently addressing Aβ
aggregation, TDP-43, and other key disease-related pathologies.
This unique approach not only diversifies the therapeutic targets
but also offers the potential for more potent treatment outcomes.
With a well demonstrated synergistic mode of action, compelling
pre-clinical and clinical data in related filed, and a strong
safety profile, PrimeC is poised to potentially provide therapeutic
efficacy in AD.
"This partnership represents a critical step forward in the
fight against Alzheimer's Disease," said Daphna Laifenfeld,
co-founder and CSO at Genetika+. "By combining our leading-edge
technologies, we anticipate the possibility of both bring
efficacious therapies to patients sooner, and to moving beyond a
one-size-fits-all approach to AD treatment and unlock the potential
for personalized, targeted therapies that significantly improve
patient outcomes."
Currently enrolling at the Stroke and Cognition Institute,
Rambam Health Care Campus, Haifa,
Israel, RoAD, NeuroSense's Phase 2 randomized, prospective
double-blind, placebo-controlled study is designed to evaluate
the therapeutic potential of PrimeC in treating AD. The study
will consist of 20 patients with mild to moderate non-familial AD.
Participants will receive PrimeC or placebo (1:1) twice daily for
12 months and will be evaluated every three months. Endpoints
include clinical outcome measurements, AD-related biomarkers, and
markers of target engagement extracted from plasma and
cerebrospinal fluid (CSF). The study is expected to reveal the
safety of PrimeC in AD, as well as shed light on the efficacy and
biological activity of this combination therapy in this
indication.
About Genetika+
Genetika+, founded in 2018 by Talia
Cohen-Solal, Ph.D., and Daphna Laifenfeld, Ph.D., is
developing personalized medicine solutions to optimize treatment
for psychiatric and neurological diseases. The company's
proprietary AI-powered platform, Stemifai, leverages stem
cell differentiation and machine learning to inform and advance CNS
drug development processes. To learn more, follow us on LinkedIn or
on Twitter @Genetikaplus.
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, please visit the Company's
website and follow NeuroSense on LinkedIn and X
(Twitter).
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 NeuroSense's collaboration with
Genetika+, and the timing and results of a Phase 2 trial for
Alzheimer's disease. 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 NeuroSense's collaboration with
Genetika+ will not bring the anticipated benefits, unexpected
R&D costs or operating expenses, the timing of expected
regulatory and business milestones, a delay in patient enrollment
for, and unanticipated results of, a Phase 2 trial for Alzheimer's
disease; the potential for PrimeC to safely and effectively target
AD; 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 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 the Company
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. 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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