Company's lead drug candidate PrimeC is currently being evaluated in a Phase IIb trial, with topline data expected in mid-2023
CAMBRIDGE, Mass., Sept. 29, 2022 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today announced it will participate in Cantor Fitzgerald's Cantor Neurology and Psychiatry Conference scheduled to take place October 6-7, 2022 in San Francisco.
- Alon Ben-Noon, NeuroSense's CEO, will be a panelist on the conference's ALS panel titled: New Treatment Paradigm with More MoAs On the Way?
- Prof. Jeremy Shefner, Chairman of NeuroSense's Scientific Advisory Board, will be the Keynote Speaker for the conference's Neurology section.
Prof. Jeremy Shefner, MD, PhD, is a neurologist at the Gregory W. Fulton ALS & Neuromuscular Disease Center; a Professor in the Department of Neurology at the Barrow Neurological Institute, one of the top neurology institutes in the U.S.; and serves as the Executive Chair of Neurology, at the University of Arizona, Phoenix. Prof. Shefner is a board certified in neurologist by the American Board of Psychiatry and Neurology, and he specializes in ALS and neuromuscular disorders. As co-founder of the Northeast ALS Clinical Trials Consortium (NEALS), he has developed numerous outcome measures for clinical trials, published more than 200 peer-reviewed papers, and is a member of the Editorial Boards of the ALS Journal and Neurotherapeutics.
About the Conference
Cantor Fitzgerald's Neurology & Psychiatry Conference, led by Dr. Charles Duncan, Cantor's Managing Director and central nervous system (CNS) expert analyst, will feature a day of interactive discussions, one-on-ones, and panel presentations. The conference will be focused on neuro-innovators, who are engaged in development and commercialization of therapeutics for high unmet need indications in the neurology and psychiatry industries. The event will be moderated by the Cantor Healthcare Team and CEOs from leading companies in the neurodegenerative space will be participating.
PrimeC, NeuroSense's lead drug candidate, a combination therapy for ALS, 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. PrimeC's upgraded formulation, which is a unique extended-release tablet, designed to maximize the synergism between the compounds, is now being evaluated in a Phase IIb clinical trial, PARADIGM, for the treatment of ALS.
NeuroSense's Phase IIb PARADIGM trial is currently enrolling patients to assess PrimeC's efficacy, as well as safety and tolerability, in people living with ALS. The study is randomizing 69 people living with ALS in a 2:1 ratio to receive PrimeC or placebo, respectively. Primary endpoints of the study include assessment of ALS biomarkers, evaluation of clinical efficacy, improvement in quality of life, as well as safety and tolerability. Topline data are expected in mid 2023.
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.
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 investor 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.