PARADIGM Trial Shows PrimeC Slows ALS Progression in High-Risk Patients

NeuroSense Therapeutics, a biotech firm dedicated to developing innovative treatments for severe neurodegenerative diseases, has reported promising results from its Phase 2b PARADIGM clinical trial. The trial focused on PrimeC, a novel drug candidate, and its impact on high-risk patients with Amyotrophic Lateral Sclerosis (ALS). The data revealed that PrimeC significantly slowed the disease's progression by 43% compared to a placebo, a statistically significant outcome.

The ALSFRS-R scale, a widely recognized tool for tracking ALS progression, showed a 5.04-point difference favoring PrimeC, indicating its potential in managing the disease. High-risk ALS patients, who are at a greater risk for rapid progression, make up about half of the ALS patient population. The trial's findings suggest that PrimeC could offer a new standard of care if approved following further trials.

Jeremy M. Shefner M.D., Ph.D., a NeuroSense advisor and Neurology Professor, highlighted the enthusiasm surrounding PrimeC's impact on ALS patients. The drug's consistent effects across different patient subgroups were particularly noted. Newly diagnosed patients treated with PrimeC also exhibited a 52% slowing of disease progression, translating to a 7.76-point difference on the ALSFRS-R scale.

In the Intent-to-treat population analysis, PrimeC showed a 31% reduction in disease progression, amounting to a 3.2-point difference on the ALSFRS-R scale. For newly diagnosed patients, there was a 36% reduction, corresponding to a 4.56-point difference. The PARADIGM trial, which included participants from Canada, Italy, and Israel, also demonstrated PrimeC's effectiveness in reducing symptom scores for patients with disease durations of up to 18 to 24 months.

NeuroSense plans to use these findings to refine the design of upcoming pivotal trials, aiming to enhance the likelihood of success and cost-effectiveness. The company's CEO, Alon Ben-Noon, expressed optimism about PrimeC's potential, noting its significant impact on patients in earlier stages of ALS with aggressive disease progression.

ALS is an incurable neurodegenerative disease characterized by rapid paralysis and death, typically within 2-5 years post-diagnosis. The ALSFRS-R scale is crucial in tracking the physical decline of ALS patients, with even a single point change having a substantial effect on their quality of life.

PrimeC is a unique combination of two FDA-approved drugs, ciprofloxacin and celecoxib, designed to target multiple mechanisms contributing to ALS, including motor neuron degeneration and inflammation. It has already demonstrated safety and efficacy in a Phase 2a clinical trial and has received Orphan Drug Designation from both the U.S. and European regulatory agencies.

NeuroSense Therapeutics is committed to addressing the significant unmet medical needs of patients with debilitating neurodegenerative diseases, including ALS, Alzheimer's, and Parkinson's. The company's strategy involves developing therapies that target multiple disease pathways, based on extensive research and biomarker analysis.