PrimeC Treatment for ALS Associated With Functional Improvements and Extended Survival According to 12-Month PARADIGM Data

New 12-month results from the PARADIGM clinical trial (NCT05357950) demonstrated a significant improvement in the rate of decline of Amyotrophic Lateral Sclerosis (ALS) Functional Rating Scale-Revised (ALSFRS-R) scores and survival rates for adults with ALS treated with PrimeC (ciprofloxacin/celecoxib; NeuroSense Therapeutics, Cambridge, MA) compared with placebo.

PARADIGM is a randomized, multi-center, prospective, placebo-controlled phase 2b study evaluating the efficacy, tolerability, and safety of PrimeC for individuals with ALS. Researchers reported that 96% of the 68 adult participants (aged 18 to 75 years with familial or sporadic ALS) who completed the 6-month double-blind portion of the study continued to receive PrimeC treatment through the 12-month open label extension (OLE).

Participants treated with PrimeC from the start of the trial experienced improved outcomes compared with those receiving placebo including

• A difference of 6.5 points in the ALSFRS-R score, which represents a 36% improvement (P=.009).
• A 43% better survival rate.

“The promising results from the 12-month PARADIGM study highlight the significant potential of PrimeC as a disease-modifying drug for ALS. These findings underscore the importance of early intervention, which can lead to more substantial benefits,” said Vivian Drory, MD, Head of the ALS Clinic at Tel-Aviv Sourasky Medical Center.