FDA Clears Clinical Trials on Investigational New Drug for ALS

Amyotrophic lateral sclerosis, ALS, is a life-threatening neurodegenerative disease that can lead to paralysis and death. Over 5,000 individuals in the United States are diagnosed with ALS each year, most of whom will die within five years of diagnosis. The fight to treat ALS has proven difficult, with many companies trying and failing to develop new treatments. In a recent press release, NeuroSense announced that it was one step closer to treatment as the FDA cleared PrimeC, its investigational new drug, for Phase IIb clinical trials.

The FDA approval process is long and rigorous, requiring multiple clinical trials, reviews, and collaboration. PrimeC is an extended-release oral medication with fixed doses of ciprofloxacin and celecoxib. Both components are already FDA-approved for other clinical indications.

The press release states, “PrimeC is designed to synergistically target several key mechanisms of amyotrophic lateral sclerosis (ALS) that contribute to motor neuron degeneration, inflammation, iron accumulation, and impaired RNA regulation to potentially inhibit the progression of ALS.”

Phase IIa clinical trials proved that this medication had the potential to reduce functional and respiratory deterioration. This most recent FDA clearance will allow the company to begin a double-blind, placebo-controlled, multinational clinical trial. The trial results will deliver information on the safety and tolerability of the medication.

The study is designed to recruit 69 participants, 46 of whom receive PrimeC, and 23 will receive a placebo. The study will analyze ALS biomarkers, clinical efficacy, and quality of life in the experimental and control groups to determine whether the study results are clinically significant.

"FDA's acceptance of our IND paves the way for NeuroSense to commence patient enrollment in the US and is another significant milestone achieved in our drug development plan," stated NeuroSense CEO Alon Ben-Noon in the press release. "This clinical trial is evaluating our new and improved extended-release formulation of PrimeC, which may provide a better outcome than already observed in our prior Phase 2a study. We are pleased to offer PrimeC to patients who are eager to take part in the clinical program, and we look forward to completing enrollment and announcing results in the next several months — mid 2023."