- Ferenc Tracik, MD to deliver presentation - "From Monotherapy to Combination Therapy: Considering a Paradigm Shift to Target Complexity of ALS"
- Phase IIb ALS study for NeuroSense's combination therapy PrimeC expected to commence Q2 2022
CAMBRIDGE, Mass., May 23, 2022 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today announced its Chief Medical Officer, Dr. Ferenc Tracik, will deliver a presentation on May 26th at the ALS Drug Development Summit, which is scheduled to take place on May 24 – 26, 2022 in Boston, Massachusetts.
"We look forward to sharing our results and expertise at the ALS Drug Development Summit. Elucidation of ALS-related biomarkers is going to have a major impact on the way this disease is treated and will, in turn, be a vital component of PrimeC's regulatory approval. PARADIGM, NeuroSense's Phase IIb trial, will be monitoring these biomarkers in an effort to demonstrate a deceleration in disease progression, in addition to evaluating the clinical efficacy and improvement in quality of life," commented Dr. Tracik.
Dr. Tracik's presentation will include an overview of the design of NeuroSense's upcoming Phase IIb ALS study, PARADIGM, and the therapeutic efficacy demonstrated in its Phase IIa trial and pre-clinical animal models (Zebrafish) to assess a synergistic combination therapy. In addition to his presentation, Dr. Tracik will be a panelist at the ALS Drug Development Summit session on "Mechanisms, Targets, & Therapeutic Potential: Dissecting Exciting Opportunities to Drive Novel Therapeutic Strategies."
NeuroSense has been increasingly active at scientific and industry conferences. Dr. Shiran Zimri, the Company's Head of Scientific Program, attended the Target ALS conference in Boston on May 3-5, 2022, and she, along with Dr. Tracik, will participate in the European Network to Cure ALS (ENCALS) conference in Edinburgh, Scotland on June 1-3, 2022.
Also attending the ALS Drug Development Summit, NeuroSense's VP of Business Development, Nedira Salzman-Frenkel, commented, "Through conferences like these, NeuroSense is able to strengthen existing connections and explore new scientific collaborations. We believe our combination therapy, PrimeC, offers a potentially effective, easily administered, and safe solution to this unmet need."
NeuroSense's lead therapeutic candidate, PrimeC, is a novel formulation consisting of unique doses of two FDA-approved drugs designed to work synergistically on several targets including regulating microRNA synthesis, affecting iron accumulation, and reducing neuroinflammation. In a Phase IIa ALS trial, treatment with PrimeC reduced functional and respiratory deterioration, altered ALS-related biomarkers in a statistically significant manner, and was shown to be safe and effective. Through a collaboration with Massachusetts General Hospital in Boston on novel Neuron-Derived Exosomes, 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. PrimeC was granted Orphan Drug Designation by the FDA and the European Medicines Agency (EMA). The Company plans to initiate a Phase IIb double-blind placebo-controlled multinational study in ALS in Q2 2022 with an optimized dose and a unique upgraded formulation of PrimeC.
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 US alone, with an annual disease burden of $1 billion. The number of patients with ALS is expected to grow 24% by 2040 in the US 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 scientific 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.