NeuroSense Therapeutics Reports Positive Results in Phase IIa Clinical Study in ALS and Patent Allowance in the USA for PrimeC
HERZLIYA, Israel, March 2, 2021 /PRNewswire/ -- NeuroSense Therapeutics, a biotechnology company developing treatments for neurodegenerative diseases such as Amyotrophic Lateral Sclerosis (ALS), based on a novel combination drug therapy aiming at slowing or halting the disease progression, announces the successful completion of its first Phase IIa study. The study, NST002, aimed at establishing various safety endpoints for the company's first drug candidate PrimeC in 15 ALS patients, over a 12-month period. Study results clearly demonstrated that the drug was both safe and tolerable in ALS patient population.
Additionally, initial clinical signals were observed as overall disease decline was slower than expected compared with historical controls. The trial was conducted in the ALS clinic at Tel-Aviv Sourasky Medical Center (TASMC). The successful completion of this trial paves the way for PrimeC to become a leading candidate in the fight against a debilitating disease with no cure and very few, limited treatment options.
Of significance, all patients participating in the trial have opted to continue into an extension study with PrimeC.
Alon Ben-Noon, NeuroSense's CEO stated: "This study outcome provides important validation of our pharmaceutical pipeline and particularly PrimeC. We are very satisfied with the study's results and are currently planning a robust pivotal trial to confirm the efficacy of PrimeC in a double-blind placebo-controlled study with fine-tuned doses and a unique upgraded formulation, which maximizes the synergistic effect between the compounds of our combination drug PrimeC."
Prof. Vivian Drory, Head of the ALS clinic at TASMC and Principal Investigator of the NST002 study, stated: "We are excited by the potential efficacy of the drug, despite the limited size of the trial population, and are hopeful and enthusiastic for the initiation of a larger trial."
In parallel to the completion of the study, NeuroSense has received a Patent Allowance in the USA for their drug combination. An additional patent on the novel formulation has recently been submitted, and NeuroSense expects to submit further patents based on clinical data resulting from its upcoming trials.
About NeuroSense Therapeutics
NeuroSense Therapeutics is a clinical stage drug development company founded in 2016, developing ground-breaking treatment for ALS patients, as well as for patients suffering from other neurodegenerative diseases.
In pre-clinical models of ALS, PrimeC showed outstanding results. These results were significantly superior to the outcome produced by other investigational or approved drugs when tested in these models.
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SOURCE NeuroSense Therapeutics