- Binding Term Sheet with a leading global pharmaceutical
company includes a substantial upfront payment and funding for the
Phase 3 study
- Additionally, milestone payments and double-digit royalties
on annual net sales
- The transaction is subject to finalization of a definitive
agreement, anticipated in Q1 2025
CAMBRIDGE, Mass., Dec. 23,
2024 /PRNewswire/ -- NeuroSense Therapeutics
Ltd. (Nasdaq: NRSN) ("NeuroSense"), a late-clinical stage
biotechnology company developing novel treatments for severe
neurodegenerative diseases, announced today that it has entered
into a binding term sheet with a leading global pharmaceutical
company to advance the development and commercialization of PrimeC,
its proprietary treatment drug for amyotrophic lateral sclerosis
(ALS) in certain key territories. NeuroSense would retain full
rights to PrimeC in other key territories.
The binding term sheet outlines substantial financial terms from
the pharmaceutical company, including:
- A substantial upfront payment upon signing a definitive
agreement,
- Funding for the Phase 3 clinical trial,
- Regulatory and net sales milestone payments, and
- A tiered royalty structure reaching double-digit percentage on
annual net sales.
The binding term sheet is subject to finalization of a
definitive agreement, anticipated in the first quarter of 2025.
The pharmaceutical company would have an exclusive license to
distribute, market, promote, sell and develop PrimeC for ALS in
certain key markets, and non-exclusive rights for research and
manufacturing for PrimeC for ALS, subject to terms and conditions
in the definitive agreement.
PrimeC is a proprietary fixed-dose combination of two
FDA-approved drugs, uniquely formulated to enhance bioavailability
and provide synergistic effects that target multiple ALS disease
pathways. Results from NeuroSense's Phase 2b PARADIGM clinical trial demonstrated positive
safety and efficacy, strengthening confidence in its potential to
address the urgent unmet medical need in ALS.
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 people
are diagnosed with ALS in the U.S. alone, with an annual disease
burden of $1 billion. The number of people living with ALS is
expected to grow by 24% by 2040 in the U.S. and EU.
About PARADIGM
PARADIGM is a prospective, multinational,
randomized, double-blind, placebo-controlled Phase
2b (NCT05357950) clinical trial of
PrimeC in ALS. The trial included 68 participants living with ALS
in Canada, Italy, and Israel.
During the first 6 months of the trial, 45 participants were
randomized to receive PrimeC, and 23 participants were randomized
to receive placebo. This was followed by a 12-month open-label
extension with all participants receiving PrimeC in a blinded
manner, where neither the participants nor the clinical staff were
aware of the initial treatment allocation.
Most patients enrolled in both the active and placebo arms of
the trial were concurrently treated with Riluzole, the ALS standard
of care medication, indicating PrimeC slowed disease progression
well beyond the level afforded by the FDA approved ALS drug.
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 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
a Phase 2a clinical trial which met its safety and efficacy
endpoints including reducing functional and respiratory
deterioration and statistically significant changes in ALS-related
biological markers indicating PrimeC's biological activity. PrimeC
was granted Orphan Drug Designation by the U.S. Food and Drug
Administration and the European Medicines Agency.
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,
YouTube and X. Information that may be important to
investors may be routinely posted on our website and these social
media channels.
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 the terms of license and timing of a definitive
agreement or if a definitive agreement is executed at all. 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 a definitive
agreement of the license to the global pharmaceutical company will
be delayed or not executed at all, or that, if executed, it will
not be on terms described above, the risk that contemplated license
agreement, if executed, will not lead to the current anticipated
benefits to NeuroSense, the risk of a delay in submission by the
Company of its regulatory dossier, that regulatory approvals
for PrimeC will be delayed or not obtained in Canada or elsewhere; unexpected R&D costs
or operating expenses, insufficient capital to complete development
of PrimeC, a delay in the reporting of additional results from
PARADIGM clinical trial, the timing of expected regulatory and
business milestones, risks associated with meeting with the FDA and
Health Canada to determine the best path forward following the
results from PARADIGM clinical trial, including a delay in any such
meeting; 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; timing for reporting data; the development and commercial
potential of any product candidates of Neurosense; the ability of
NeuroSense to remain listed on Nasdaq; 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
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's
subsequent filings with the SEC. Forward-looking statements
contained in this announcement are made as of this date, and
NeuroSense undertakes no duty to update such information except as
required under applicable law.
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