Workflow
NeuroSense Therapeutics Announces Positive Biomarker Data from ALS Phase 2b Clinical Trial

Core Insights - NeuroSense Therapeutics has announced positive 12-month iron biomarker data from its Phase IIb study (PARADIGM), indicating the potential of PrimeC as a transformative therapy for ALS, with improved survival rates by 43% and slowed disease progression by 36% [1][5] Company Overview - NeuroSense Therapeutics is a late-clinical 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] Study Results - The 12-month study results showed a significant decrease in ferritin levels and an increase in transferrin levels, indicating improved iron metabolism and disease mitigation [3][4] - Iron levels remained stable over the 12-month dosing period, with a mean difference of 4.536 µmol/L (95% CI [1.143, 7.929], p=0.01) compared to placebo [3] Clinical Implications - The positive changes in iron metabolism correlate with improved clinical outcomes, as patients on PrimeC exhibited better functionality and survival rates compared to those on placebo [4] - The study's findings support the advancement to Phase 3 testing of PrimeC in ALS, as highlighted by Dr. Merit Cudkowicz [5] Background on ALS - ALS is an incurable neurodegenerative disease that leads to complete paralysis and death within 2-5 years from diagnosis, with over 5,000 new cases diagnosed annually in the U.S. [6] - The disease burden in the U.S. is approximately $1 billion annually, and the number of people living with ALS is projected to grow by 24% by 2040 in the U.S. and EU [6] About PrimeC - PrimeC is NeuroSense's lead drug candidate, a novel extended-release oral formulation combining ciprofloxacin and celecoxib, designed to target mechanisms contributing to ALS progression [10] - The drug has shown efficacy in reducing functional and respiratory deterioration and has received Orphan Drug Designation from the FDA and EMA [10] About the PARADIGM Study - The PARADIGM trial is a multinational, randomized, double-blind, placebo-controlled Phase 2b study involving 68 ALS participants across Canada, Italy, and Israel [8] - In the 6-month double-blind segment, PrimeC demonstrated a 29% efficacy difference compared to placebo, with a statistically significant slowing of disease progression observed [9]