NeuroSense Therapeutics Ltd (NASDAQ: NRSN) has announced that the FDA has given it clearance to commence a pharmaceutical study of PrimeC in healthy adult volunteers.
PrimeC is a formulation of Ciprofloxacin and Celecoxib targeting ALS mechanisms.
PrimeC is a proprietary extended-release oral formula comprising a unique fixed-dose combination of celecoxib and Ciprofloxacin, which are both FDA-approved drugs. The formulation has been designed to target various important mechanisms of amyotrophic lateral sclerosis contributing to motor neuron inflammation, degeneration, iron accumulation, and impaired RNA regulation to inhibit ALS progression.
The FDA and European Medicines Agency granted PrimeC orphan drug designation. The company has completed a phase IIa clinical trial that successfully attained efficacy and safety endpoints, including reducing respiratory and functional deterioration with statistically significant changes in ALS-related biological markers that indicate PrimeC’s biological activity. NeuroSence plans to commence a Phase IIb double-blind placebo-controlled multinational trial in Q2 2022 with an optimized dose and a distinct upgraded formulation.
The study is a Phase one randomized, open-label, single-dose three treatment, a three-period study evaluating the impact of food on the bioavailability of PrimeC relative to the bioavailability of co-administered celecoxib capsules and ciprofloxacin tables in 12 health adult participants in the US.
PrimeC has the potential of helping people with ALS
CEO Alon Ben-Noon stated, “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. As we prepare to initiate our Phase IIb study in the next few months, the goal of our pharmacokinetic study under FDA IND is to generate additional data on the bioavailability of PrimeC as it relates to food intake in healthy individuals.”
Recently the company announced the third stage of its partnership with Massachusetts General Hospital on proprietary Neuron-Derived Exosomes to further determine the biological changes in ALS-associated pathologies and PrimeC’s effect on relevant targets. The company will release results from the study in Q2 2022.
