NeuroSense Therapeutics Ltd., a company developing treatments for severe neurodegenerative diseases, announced it has received approval from the Italian Medicines Agency (AIFA) to commence patient enrollment in Italy for PARADIGM, the Company’s Phase 2b clinical trial of its lead drug candidate PrimeC in the treatment of amyotrophic lateral sclerosis (ALS). PARADIGM is currently enrolling patients in Israel and recently received clearance from the U.S. Food and Drug Administration to open clinical sites for patient recruitment in the U.S. NeuroSense expects to enroll and dose the first patients in Italy and in the U.S. in the next few weeks.
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The Phase 2b (NCT05357950) double-blind, placebo-controlled, multinational clinical trial aims to assess PrimeC’s efficacy, as well as safety and tolerability, in people living with ALS. The study is enrolling and randomizing 69 people living with ALS in a 2:1 ratio to receive PrimeC or placebo, respectively. Study participants are allowed to continue standard of care (SOC) treatment of approved products. Primary endpoints of the study include assessment of ALS-biomarkers, evaluation of clinical efficacy, and improvement in quality of life. All subjects who complete the 6 month double-blind, placebo-controlled dosing period will be switched to the PrimeC active arm for a 12-month open label extension.
“Clearance from AIFA, Italy’s health regulatory agency, is another important milestone achieved that supports our goal of providing patients in need from the EU, in addition to the US and other regions, the opportunity to join the PARADIGM study and receive PrimeC, which aims to target pertinent mechanisms in ALS with the hope for a meaningful clinical benefit.” stated NeuroSense CEO Alon Ben-Noon.
PrimeC, NeuroSense’s lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. 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.