- Last patient completed the double-blind segment of PARADIGM, a Phase 2b ALS Trial
- Clinical efficacy top-line results from PARADIGM expected in December 2023
CAMBRIDGE, Mass., Nov. 9, 2023 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today announced scientific presentations at three upcoming conferences.
Mr. Nitai Kerem, NeuroSense's Scientific Project Manager, will present a poster on NeuroSense's latest biomarker data at Neuroscience 2023, the Society of Neuroscience's annual conference. This is the largest U.S. Neuroscience conference, bringing together scientists and physicians devoted to understanding the brain and the nervous system. The conference will be held in Washington D.C. on November 11th-15th, 2023.
ALS ONE's 6th Annual ALS Research Symposium
Dr. Shiran Zimri, VP of R&D at NeuroSense, will present the Company's latest clinical updates and findings in her talk titled "Shifting the Paradigm - A Biomarker Driven Approach for Studying Amyotrophic Lateral Sclerosis (ALS) Therapy Activity" at ALS ONE's 6th Annual ALS Research Symposium, to be held virtually on November 16th-17th, and 20th 2023. In addition to NeuroSense being a sponsor of this year's conference, this marks the fourth year NeuroSense will present at ALS ONE's symposium.
With a focus on the Company's Phase 2b PARADIGM PrimeC study, Dr. Zimri will present key elements of PrimeC's development program. The last patient has completed the double-blind segment of PARADIGM, with clinical efficacy results (secondary endpoints) expected in December 2023.
The 34th International Symposium on ALS/MND
Dr. Shiran Zimri and Dr. Ferenc Tracik, NeuroSense's Chief Medical Officer, will present a poster at the 34th International Symposium on ALS/MND, which brings together leading ALS and motor neuron disease (MND) experts, European patient advocacy groups, and ALS foundations, on December 6th-9th, 2023 in Basel, Switzerland.
"We believe NeuroSense's highly innovative approach of using biomarkers as a primary efficacy endpoint in our Phase 2b PARADIGM study will further elucidate the biological activity of PrimeC and help us to better understand the effect on people living with ALS," said Dr. Zimri. "We are excited to soon begin sharing the initial results of the double-blind segment of our Phase 2b trial to determine our drug's impact on efficacy."
NeuroSense's Phase 2b PARADIGM trial evaluating PrimeC's efficacy, as well as safety and tolerability, in people living with ALS. The study is randomized 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.
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.
PrimeC, NeuroSense's lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of amyotrophic lateral sclerosis (ALS) that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired RNA regulation to potentially inhibit the progression of ALS. NeuroSense completed a Phase 2a clinical trial which 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 was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
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 the timing for release of results from the Company's Phase 2b trial, . Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and 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 results from PARADIGM clinical trial, a delay in patient enrollment for a Phase 2 trial for Alzheimer's disease or its planned Phase 3 pivotal ALS trial of PrimeC; 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 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)., You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in the Annual Report on Form 20-F filed with the Securities and Exchange Commission 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.