NeuroSense Therapeutics has announced 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 demonstrated 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.
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"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," Alon Ben-Noon, NeuroSense's CEO said.
"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," Prof. Vivian Drory, Head of the ALS clinic at TASMC and Principal Investigator of the NST002 study, said.
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.