Full Press Release Details
Medicines Agency Grants NeuroSense SME Status
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.
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.
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.
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.
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."
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.
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.
information: Email: info@neurosense-tx.com, Tel: +972 (0)9 799 6183