NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today announced the Company will participate in Maxim Group's panel discussion on Innovations in ALS: Exploring New Treatments In Development, which will take place on Tuesday, June 28th, 2022.
The panel discussion will focus on ALS research and development and will be moderated by Maxim Group Senior Biotech Analyst, Naz Rahman, CFA, and two panelists: NeuroSense's Co-Founder & CEO Alon Ben-Noon and Rob Etherington, President & CEO of Clene, Inc.
Amyotrophic lateral sclerosis (ALS) remains a highly debilitating and deadly neurological disease despite having approved therapies on the market. Current therapies provide marginal benefit for some patients, extending survival for only a few months, and there remains a very high unmet need for new therapies and research into the disease.
NeuroSense has commenced enrollment of people living with ALS in its Phase IIb clinical trial, PARADIGM, with its lead drug candidate PrimeC, in Israel. The Company intends to open additional sites for PARADIGM in Italy and the USA, with expected completion of enrollment by the end of 2022. NeuroSense anticipates topline results from the trial in Q2 2023.
PrimeC is a novel, patented formulation consisting of specific doses of two FDA-approved drugs, ciprofloxacin and celecoxib, designed to work synergistically on multiple targets by regulating microRNA synthesis, modulating iron accumulation, and reducing neuroinflammation.
"I look forward to participating in the panel discussion to share knowledge about the causes of ALS and potential treatments in development, which aim to slow down disease progression, alleviate symptoms, and extend life. We appreciate Maxim taking an active role in supporting the advancement and acceleration of therapies to address this dire unmet need," stated NeuroSense CEO, Alon Ben-Noon.
PrimeC, 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 determine the biological changes in ALS-related pathologies and the effect of PrimeC on relevant targets. Results from this study are expected Q2 2022.
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.
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.
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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 participation in conferences; 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.
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