NeuroSense Drug Candidate Slows Disease Progression in ALS
In a potential win for people living with amyotrophic lateral sclerosis (ALS), NeuroSense Therapeutics (Nasdaq: NRSN) has announced that its lead drug candidate, Prime C, has demonstrated a statistically significant slowing of disease progression in high-risk ALS patients in a Phase 2b clinical trial. PrimeC is a novel extended-release oral formulation composed of a unique fixed-dose combination of FDA approved drugs, ciprofloxacin and celecoxib.
NeuroSense’s randomized, double-blind, placebo-controlled Phase 2 PARADIGM study enrolled 68 participants in Canada, Italy, and Israel. 96% of the trial participants who completed the 6-month portion of the trial chose to receive treatment with PrimeC through a 12-month open label extension. The study showed that PrimeC slowed disease progression by 43% in pre-specified high-risk ALS patients.
Commenting on the results, NeuroSense CEO, Alon Ben-Noon, said, “We believe this is one of the most compelling results seen to-date in an advanced, double-blind clinical trial in ALS, demonstrating slowing the progression of ALS in patients in earlier stages with an aggressive disease. Seeing PrimeC’s significant impact in the general PARADIGM population in all various clinical aspects, and even more in multiple sub-groups on the gold-standard ALSFRS-R, is truly gratifying, and we are looking forward to analyzing and reporting on the 12-month study survival data in the next few weeks.”
ALS is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. It affects 5,000 Americans each year and has an annual disease burden of $1 billion.
About NeuroSense
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. For additional information, we invite you to visit our website and follow us on LinkedIn and X.