By Sam Boughedda
Investing.com -- Neurosense Therapeutics Ltd (NASDAQ:NRSN), a company developing treatments for severe neurodegenerative diseases, rocketed over 290% higher Monday after announcing it has received clearance from the Food and Drug Administration to initiate a pharmacokinetic study of PrimeC.
PrimeC is a drug designed to target key components of amyotrophic lateral sclerosis (ALS) and potentially inhibit the progression. PrimeC is comprised of two FDA-approved drugs: ciprofloxacin and celecoxib.
The drug was previously granted Orphan Drug Designation by the FDA and the European Medicines Agency.
NeuroSense completed a Phase 2a clinical study that met safety and efficacy endpoints, including reducing functional and respiratory deterioration.
The company now plans to initiate a Phase 2b multinational study in the second quarter.
"Data from our Phase IIa clinical study confirmed that PrimeC is a novel therapy with the potential to help people with ALS and address a $3 billion market in need of a more effective treatment," said NeuroSense CEO Alon Ben-Noon.