PrimeC led to significant slowing in rate of decline in ALS at 12 months

NeuroSense Therapeutics Ltd. has reported positive results from the 12-month data analysis of a phase 2b study evaluating a novel extended-release oral formulation combination therapy in patients with amyotrophic lateral sclerosis.

In a release, NeuroSense said that data from the prospective, multinational, randomized, double-blind, placebo-controlled PARADIGM study showed that treatment with PrimeC — a fixed-dose combination of ciprofloxacin and celecoxib — led to significant slowing in rate of decline as measured by a 6.5-point difference (36% improvement) in the ALS Functional Rating Scale-Revised (ALSFRS-R) score.

In addition, at 12 months, individuals who were administered PrimeC throughout the study demonstrated 43% better survival than those initially on placebo, while the survival rate of participants on PrimeC improved by 63% compared with participants who received a placebo.

According to statistics cited in the release, 96% of trial participants who completed the 6-month double-blind portion of the study elected to continue into the 12-month open-label extension phase.

“The 12-month PrimeC data support moving forward to phase 3 testing,” Merit Cudkowicz, MD, MSc, chair of neurology and director of the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital and scientific advisory board member at Neurosense, told Healio in an email. “It also shows the power of open label extension studies to gather more data on safety, biomarkers and efficacy outcome measurements."