- NeuroSense will leverage its extensive experience in biomarker
utilization to advance early diagnosis and treatment in the
neurodegeneration field
- Lonza to develop, optimize, and qualify a method utilizing
Neuron-Derived Exosomes ("NDEs"), set to be integrated into the
clinical development program of PrimeC by NeuroSense
- Lonza's Dev-on-Demand solution to enable NeuroSense to access
Lonza's process development with rapid initiation, execution, and
delivery of work
BASEL,
Switzerland and CAMBRIDGE,
Mass., April 9, 2024 /PRNewswire/ -- Lonza (SIX:
LONN), a global development and manufacturing partner to the
pharma, biotech and nutrition industries, and NeuroSense
Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a company
developing treatments for amyotrophic lateral sclerosis (ALS) and
other severe neurodegenerative diseases, announced a collaboration
to evaluate biological changes occurring in people with
neurodegenerative diseases, including ALS.
This agreement provides NeuroSense with access to Lonza's
unparalleled, state-of-the-art extracellular vesicles expertise and
capabilities quickly and on an 'on-demand' basis, without further
commitments. NeuroSense will leverage its extensive experience in
biomarker utilization in neurodegenerative diseases. Lonza will
provide the development, optimization, and qualification of a
method measuring biomarkers from NDEs, which will be integrated
into the development of NeuroSense's lead product candidate for
ALS, PrimeC.
Davide Zocco, Head of Exosomes Development, Lonza,
commented: "Lonza has made significant investments in the
exosome field over the last decade, including the acquisition of
Exosomics, reflecting our commitment to enable innovators to
advance their therapies. Our 'Dev-on-Demand' solution provides
NeuroSense with access to expert scientists working in
state-of-the-art laboratories for their development activities. The
team and platform make Lonza the partner of choice for NeuroSense
to identify exosomes-based biomarkers."
Alon Ben-Noon, NeuroSense's
CEO, added: "We believe this collaboration could be a
game-changer for the ALS and neurodegeneration field, as findings
in such biomarkers may advance early diagnosis and treatment, as
well as expedite the regulatory pathway for new treatments for the
millions of people who suffer from neurodegenerative diseases.
Collaborating with Lonza enables us to tap into some of the world's
top experts in exosomes-based therapies research to develop another
important measure of PrimeC's efficacy."
NeuroSense recently reported positive topline results from the
six-month double-blind portion of its Phase 2b PARADIGM trial, a multinational, randomized,
double-blind, placebo-controlled clinical study of PrimeC in people
living with ALS. Patients treated with PrimeC had a statistically
significant slowing of disease progression in the pre-specified Per
Protocol (PP) population as compared to placebo. Additional
biomarker and efficacy endpoints are expected H1 2024.
Additional Information
About NDEs
NDEs are small extracellular vesicles generated by neurons that
encapsulate a variety of molecules such as proteins, nucleic acids,
and metabolites. Identification and measurement of NDEs and their
cargo through easily accessible bodily fluids including plasma can
facilitate the discovery of new biomarkers for prognosis and
therapy, as these vesicles can pass the blood-brain barrier and
noninvasively provide a depiction of the current physiological
status of neurons in the brain.
About ALS
Amyotrophic lateral sclerosis (ALS) is an incurable
neurodegenerative disease that causes complete paralysis and death
within 2-5 years from diagnosis. Every year, more than 5,000
patients are diagnosed with ALS in the U.S. alone, with an annual
disease burden of $1 billion. The
number of patients with ALS is expected to grow 24% by 2040 in the
U.S. and EU.
About PrimeC
PrimeC, NeuroSense's lead drug candidate, is a novel
extended-release oral formulation composed of a unique fixed-dose
combination of two FDA-approved drugs: ciprofloxacin and celecoxib.
PrimeC is designed to synergistically target several key mechanisms
of amyotrophic lateral sclerosis (ALS) that contribute to motor
neuron degeneration, inflammation, iron accumulation and impaired
ribonucleic acid ("RNA") regulation to potentially inhibit the
progression of ALS. NeuroSense completed the six-month double-blind
portion of its Phase 2b ALS clinical
trial which met its safety and tolerability endpoints, as well as
showing a statistically significant slowing of disease progression
in the pre-specified Per Protocol (PP) population. Additional data
from the Phase 2b trial are expected
H1 2024. PrimeC was granted Orphan Drug Designation by the U.S.
Food and Drug Administration (FDA) and the European Medicines
Agency (EMA).
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 X, formerly known as
Twitter.
Lonza Disclaimer
Certain matters discussed in this media advisory may constitute
forward-looking statements. These statements are based on current
expectations and estimates of Lonza Group Ltd, although Lonza Group
Ltd can give no assurance that these expectations and estimates
will be achieved. Investors are cautioned that all forward-looking
statements involve risks and uncertainty and are qualified in their
entirety. The actual results may differ materially in the future
from the forward-looking statements included in this media advisory
due to various factors. Furthermore, except as otherwise required
by law, Lonza Group Ltd disclaims any intention or obligation to
update the statements contained in this media advisory.
All trademarks belong to Lonza and are registered in CH, US
and/or EU, or belong to their respective third-party owners and are
used only for informational purposes.
NeuroSense 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 agreement
with Lonza and the timing for reporting
additional biomarker and efficacy endpoints from the
Phase 2b PARADIGM 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 the risk that the agreement
with Lonzo will not bring the expected benefits, the risk of delay
in the reporting of additional biomarker and efficacy endpoints
from the Phase 2b PARADIGM trial;
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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