Core Insights - NeuroSense Therapeutics announced statistically significant positive results from the 18-month PARADIGM study, showing that PrimeC slowed disease progression in ALS patients by 33% and improved survival rates by 58% compared to placebo [1][8]. Company Overview - NeuroSense Therapeutics is a late-stage biotechnology company focused on developing treatments for severe neurodegenerative diseases, including ALS, Alzheimer's, and Parkinson's [11]. - The company aims to address significant unmet medical needs in neurodegenerative diseases through combined therapies targeting multiple pathways [11]. Product Information - PrimeC is NeuroSense's lead drug candidate, an extended-release oral formulation combining ciprofloxacin and celecoxib, designed to target mechanisms contributing to ALS progression [9][10]. - The drug has shown efficacy in reducing functional and respiratory deterioration and has received Orphan Drug Designation from the FDA and EMA [10]. Study Details - The PARADIGM study is a Phase 2b clinical trial involving 68 participants across Canada, Italy, and Israel, designed to evaluate the efficacy of PrimeC in ALS [7]. - The study demonstrated a 36% improvement in ALS Functional Rating Scale-Revised (ALSFRS-R) scores at the 12-month readout, marking the best results in ALS clinical research to date [8]. Future Developments - Results from the PARADIGM study will be presented at the 2024 International Symposium on ALS/MND, with insights from Prof. Merit Cudkowicz, a leading figure in ALS research [2]. - The company plans to provide updates on its meeting with the FDA in the coming days [4].
NeuroSense Announces Completion of PARADIGM Study Highlighting PrimeC's Significant Efficacy and Survival Benefits in ALS