Full Press Release Details
Reports Positive Results from Stage III ALS Biomarker Study
Stage III natural history study analyzed blood samples from people living with ALS, treated with standard of care. Preliminary results
show that levels of disease-related biomarkers remain steady and unchanged in people living with ALS, in contrast to the statistically
significant decline portrayed in these biomarkers when PrimeC was administered in addition to the standard of care. Stage III results
further confirmed PrimeC's MOA, and expanded insight into ALS-related biomarkers and their correlation to the progression of ALS
results are encouraging, especially in that they validate
NeuroSense's clinical strategy. The biomarker study, along with the data we collect from our Phase
IIb study, will inform the optimization of a pivotal Phase III study of PrimeC in ALS," stated NeuroSense's CEO, Alon Ben-Noon.
"NeuroSense is honored to collaborate with the world-class MGH team on this critical study."
remains at the forefront of biomarker research with the inclusion of a comprehensive
portfolio of biomarkers in our Phase IIb study. This is essential in exploring mechanistic associations in ALS,"
stated Shiran Zimri, Head of Scientific Programs at NeuroSense. "The use of neuronal
derived exosomes (NDE), a cutting-edge technology, allows one to observe key alterations in biomarkers found in the central nervous system.
We look forward to sharing more detailed results at the upcoming World Orphan Drug Congress in Boston, Massachusetts on July 11-13th."
NeuroSense's lead drug candidate is a combination therapy that was granted Orphan Drug Designation by the U.S. Food and Drug Administration
(FDA) and the European Medicines Agency (EMA). NeuroSense completed a Phase IIa clinical study which successfully 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. Through a collaboration with Massachusetts General Hospital in Boston on
novel Neuron-Derived Exosomes (NDEs), NeuroSense is working to further analyze the results and correlations to the clinical data, to
determine the biological changes in ALS-related pathologies and the magnitude of the effect of PrimeC on relevant targets..
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.
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.
additional information, we invite you to visit our website and
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,"
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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 company's PrimeC
development program; the potential for PrimeC to safely and effectively target ALS; preclinical and clinical data for PrimeC; the timing
of current and future clinical trials; the nature, strategy and focus of the company and further updates with respect thereto; and the
development and commercial potential of any product candidates of the company. Further, certain forward-looking statements are based
on assumptions as to future events that may not prove to be accurate. 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.
further information: Email: info@neurosense-tx.com, Tel: +972 (0)9 799 6183