- In collaboration with the University
of Southern California's Ichida Stem Cell Lab, PrimeC
was shown to significantly increase survival rate of induced motor
neurons in an in vitro study utilizing induced pluripotent stem
cells (iPSCs) generated from people living with ALS
- Results reinforce previous findings in multiple
models
- In a previous independent study carried out by
Dr. Ichida, PrimeC performed among the best in improving motor
neuron survival when compared to several other ALS drugs in
development and two ALS FDA approved drugs
CAMBRIDGE, Mass., Oct. 4, 2023
/PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq:
NRSN) ("NeuroSense"), a company developing treatments for severe
neurodegenerative diseases, today announced the results of a
non-sponsored in vitro study of PrimeC in
amyotrophic lateral sclerosis (ALS) conducted by Dr. Justin Ichida, PhD at the University of Southern California's (USC) Stem Cell Ichida Lab, part of the Eli and
Edythe Broad CIRM Center for Regenerative Medicine and Stem Cell
Research at USC.
Dr. Ichida's in vitro study used induced pluripotent stem
cells (iPSCs) that were derived from blood samples of people living
with ALS. The survival rate of induced motor neurons when
administered with PrimeC in comparison to each of PrimeC's
components, ciprofloxacin and celecoxib, alone was evaluated.
PrimeC showed a significant beneficial effect relative to each of
its components alone, demonstrating the synergistic effect of
PrimeC and supporting the rationale of combining the two active
components into NeuroSense's proprietary formulation. PrimeC
attenuated ALS related pathology, as depicted by the increased
survival rate. The PrimeC treated iPSCs had increased neuronal
survival compared to ALS control cells, rendering their survival
rate to be similar to healthy controls.
A previous study conducted independently by Dr. Ichida in iPSCs
has already demonstrated NeuroSense's combination therapy performed
among the best in improving motor neuron survival alongside several
other ALS drugs in development and two FDA approved ALS drugs,
Amylyx Pharmaceuticals' combination therapy, RELYVRIO, and
Mitsubishi Tanabe's Radicava.
Dr. Ichida is the John Douglas French Alzheimer's Foundation
Associate Professor of Stem Cell Biology and Regenerative Medicine
and a New York Stem Cell Foundation–Robertson Investigator. He is
widely recognized as being on the cutting edge of future treatments
and cures for ALS and Alzheimer's disease, as well as the use of
iPSCs, a state-of-the art in vitro cellular technique, in
drug testing and development.
"At our lab, we screen thousands of compounds in search of one
that may be effective in ALS, and we were very impressed by the
data resulting from our iPCS in vitro study of PrimeC. We
chose to evaluate PrimeC based on the growing body of clinical,
pre-clinical, and biomarker data on its efficacy in ALS," Dr.
Ichida stated. "As a candidate compound, NeuroSense's combination
was among the best in improving motor neuron survival. Furthermore,
in a follow-on study, where we explored specifically the
synergistic effect of PrimeC combination relative to each one of
its therapeutic agents, the results exceeded our expectations, as
PrimeC increased the survival rate to the level of the healthy
control and that got us very excited."
"Dr. Ichida has been described as being beyond the cutting edge
in his field and we are honored that he and his lab chose to
evaluate PrimeC in this non-sponsored study," stated NeuroSense
Founder and CEO, Alon Ben Noon.
"These results further bolster our confidence that PrimeC may offer
a much-needed therapy for this debilitating disease which is ALS.
We are proud that PrimeC is recognized as a leading ALS drug
candidate by the top medical institutions in the world."
Dr. Shiran Zimri, VP R&D of NeuroSense added, "These
findings present a new opportunity to potentially screen super
responder patients using iPSCs, a non-invasive method which only
requires a blood draw from the patient. Using this screening model
may result in higher efficacy in people living with ALS who are
most likely to benefit from PrimeC."
Dr. Zimri will be presenting these results at the 22nd Annual
Northeast Amyotrophic Lateral Sclerosis (NEALS) Meeting which takes
place October4-6, 2023 in Clearwater,
Florida.
NeuroSense expects clinical topline results from PARADIGM, its
Phase 2b study of PrimeC in the
treatment of ALS in the fourth quarter of 2023.
About iPSCs in Drug Development
Cellular reprogramming, particularly the generation of induced
pluripotent stem cells (iPSCs), has significant benefits for drug
development, as they can be generated from patient-specific cells,
such as skin or blood cells, and differentiated into various cell
types. Deriving patient induced motor neurons (iMNs) from a
patient's blood sample recapitulates the neurodegeneration involved
in ALS, allowing for the creation of ALS in vitro models
which ultimately provide a platform for drug screening and testing.
Furthermore, cellular reprogramming enables high-throughput,
personalized drug screening on patient derived nerve cells.
Revolutionizing drug development, iPSCs provide accurate and more
efficient models for disease research and drug discovery.
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, we invite you to visit
our website and follow us
on LinkedIn and 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 the timing of clinical top-line
results of, and the results of, the PARADIGM clinical trial.
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 a delay in
the reporting of clinical top-line results from PARADIGM clinical
trial; the potential for PrimeC to safely and effectively target
ALS; preclinical and clinical data for PrimeC; 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 March
22, 2023. 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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