- SME status offers regulatory guidance and engagement in
dialogue with EMA
- NeuroSense to open an EU office in Ulm, Germany
- Company plans to enroll patients at multiple sites across
Europe in its planned Phase 3
pivotal ALS study of PrimeC
CAMBRIDGE, Mass., Sept. 20,
2023 /PRNewswire/ -- NeuroSense Therapeutics Ltd.
(NASDAQ: NRSN) ("NeuroSense"), a company developing treatments for
severe neurodegenerative diseases, announced today that it has
opened an EU Office as well as been granted the Small and
Medium-Sized Enterprise (SME) status by the European Medicines
Agency (EMA), which offers significant benefits leading up to and
following drug regulatory approval. The EMA already granted PrimeC
Orphan Drug Status for the treatment of ALS.
NeuroSense completed enrollment in PARADIGM, its Phase
2b multinational clinical study of
PrimeC for the treatment of ALS. One-third of the 69 enrolled
patients came from sites located in Europe. Clinical topline results from PARADIGM
are expected at the end of 2023.
The Company expects to commence a global pivotal Phase 3 study
of PrimeC in ALS in 2024 with a vast number of clinical sites in
Europe. As Europe is a key market, in addition to the
USA, NeuroSense has opened an
office in Ulm, Germany to lead its
regulatory dialogue with the EMA and clinical operations during the
planned Phase 3 study.
SME status offers benefits, including regulatory guidance
and engagement in early dialogue with a multidisciplinary EMA team
throughout the development program. In addition, financial benefits
such as a 100% fee reduction for scientific advice and inspections
of facilities for orphan products, as well as a fee exemption
following marketing authorization of PrimeC in its first year of
sales.
"SME status with the EMA comes at an opportune time for
NeuroSense as we look ahead to clinical topline Phase 2b results with the expectation that it will lead
us rapidly into a pivotal Phase 3 study for ALS," stated NeuroSense
Founder and CEO, Alon Ben Noon. "We
plan to work closely with the EMA on the PrimeC development
strategy towards the initiation of the Phase 3 study across
Europe and appreciate their support of our mission in
ALS."
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 and the timing of a pivotal
Phase 3 study for ALS and a pivotal Phase 3 study for PrimeC.
Further, forward-looking statements are subject to a number of
risks and uncertainties as a result of which 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 and a delay in patient enrollment for a
pivotal ALS study of
PrimeC; greater than anticipated costs
and expenses; 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
nature, strategy and focus of the company and further updates with
respect thereto; 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), including NeuroSense's Annual Report
on Form 20-F filed with the SEC 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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SOURCE NeuroSense