- Patent valid through 2038
- Phase IIb ALS trial expected to commence H1 2022
CAMBRIDGE, Mass., April 6, 2022 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today announced the Canadian Intellectual Property Office has granted the Company a key patent titled "Compositions comprising an anti-inflammatory drug and DICER activator for treatment of neuronal diseases" having the number 3,068,149. The patent covers NeuroSense's unique fixed-dose combination of ciprofloxacin and celecoxib, two US FDA-approved drugs that are the active ingredients in PrimeC, the Company's lead drug candidate for treating Amyotrophic Lateral Sclerosis ("ALS"). This patent has already been issued in the U.S. and Australia and is valid through 2038, subject to appropriate maintenance and renewal. The Company also received a patent allowance from the European Patent Office, and similar patent applications are pending in Japan and Israel. Additional patent applications relating to the novel formulation of PrimeC and methods for the treatment of other neurodegenerative diseases using NeuroSense's platform of combination therapies including StabiliC and CogniC are pending as well.
NeuroSense's PrimeC ALS program is headed into two clinical trials, a pharmacokinetic study to be conducted under an FDA IND which is slated to commence in the next few weeks, and a Phase IIb double-blind placebo controlled multinational study to commence Q2 2022. The Phase IIb study with PrimeC's unique formulation is expected to demonstrate results that may be superior to those already achieved in a previous Phase IIa study that met its endpoints. Concurrently, NeuroSense is investigating ALS biomarkers in conjunction with Massachusetts General Hospital with the aim of increasing the success in a future pivotal clinical study. Data from the Mass General biomarker study is expected Q2 2022.
"We are pleased to receive this most recent patent grant which adds to our growing IP portfolio at this important junction as we head into a Phase IIb study. ALS is an indication in dire need of an effective treatment, and we are determined to advance our program, backed by strong IP, toward market, fulfilling our commitment to people with ALS," stated Alon Ben-Noon, NeuroSense's CEO.
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 patent applications; 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.