Phase 2b ALS
topline results expected December
2023
CAMBRIDGE, Mass., Oct. 17,
2023 /PRNewswire/ -- NeuroSense Therapeutics Ltd.
(Nasdaq: NRSN) ("NeuroSense"), a company developing treatments for
severe neurodegenerative diseases, today provided an update from
its CEO, Alon Ben-Noon, on the
Company's clinical and operational developments during and
immediately following the third quarter of 2023. The Company's
amyotrophic lateral sclerosis (ALS) Phase 2b PARADIGM trial of PrimeC is expected to report
clinical topline results Q4 2023, and a Phase 2 Alzheimer's disease
study is expected to enroll the first patient in the next several
weeks.
Non-Sponsored Study Demonstrated PrimeC has Outstanding
Effect on ALS Survival (LINK)
- At the Ichida Stem Cell Lab at University of Southern California, 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
- In another independent study carried out by Dr. Ichida in an
Innovative iPSC model, 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
Received SME Status from European Medicines Agency &
Opened Office in Germany (LINK)
- Small and Medium-Sized Enterprise (SME) status offers
regulatory guidance and engagement in dialogue with EMA
- Company plans to enroll patients at multiple sites across
Europe in its planned Phase 3
pivotal ALS study of PrimeC
Granted Patents in Europe,
Japan, and Israel for PrimeC (LINK)
- Patents valid through 2038
Ended At-The-Market Equity Offering Program (LINK)
- Company is fully funded into Q2 2024 beyond clinical Phase
2b ALS results expected Q4 2023
"On October 7, Israel endured an unprecedented brutal attack,
a massacre, by heinous terrorists identifying themselves as Hamas.
I'm relieved to report that everyone at NeuroSense is safe.
However, we are heartbroken by this dreadful event and the number
of brutally murdered and abducted innocent civilians. In the face
of such terror, NeuroSense's response remains resolute: we will
continue to advance the frontiers of science and invest every
effort into developing effective neurological treatments for those
in desperate need, without hesitation. Resilience and unity are key
here, and therefore we are also assisting people in dire need to
recover and rebuild," stated Alon
Ben-Noon, CEO of NeuroSense. "NeuroSense had a very strong
third quarter, as we confidently look ahead to reporting Phase
2b ALS clinical results for PrimeC
before the end of the year. The outstanding results from a
non-sponsored study of PrimeC in an innovative ALS model further
validate the results we've been seeing in our human clinicals and
in biomarker and in vitro studies."
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 cash runway of the Company,
the timing of clinical top-line results of, the results of, the
PARADIGM clinical trial and the timing of a Phase 2 study for
Alzheirmer's disease and patient enrollment regarding a Phase 3
pivotal ALS study of PrimeC. 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 clinical top-line results from PARADIGM
clinical trial, a delay in patient enrollment for a Phase 2 study
for Alzheirmer's disease or its planned Phase 3 pivotal ALS study
of PrimeC; 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.
Logo -
https://mma.prnewswire.com/media/1707291/NeuroSense_Therapeutics_Logo.jpg
Photo - https://mma.prnewswire.com/media/2249474/AlonBN.jpg
View original content to download
multimedia:https://www.prnewswire.com/news-releases/neurosense-ceo-provides-q3-2023-update-301958703.html
SOURCE NeuroSense