Clinical Studies Initiation And Orphan Drug Designation

PrimeC, developed by NeuroSense Therapeutics, has received an orphan drug status from the FDA. Since ALS is a rare disease, financial incentives are crucial to develop drugs profitably without assistance from the government. An orphan drug status allows manufacturers to benefit from market exclusivity, support from the FDA, tax exemptions and fee reductions.

In preclinical studies, mutant and wild type zebrafish were treated with PrimeC, and the results demonstrated neuroprotection and a regained ability to swim. Following the positive outcomes, NeuroSense has begun two clinical trials with ALS patients based in Tel Aviv, Israel and Phoenix, Arizona. The ALS Functional Rating Scale Revised (ALSFRS-R) and other general assessments will be used to measure the progression of symptoms of ALS. All patients involved in the study will take PrimeC for 12 months, with patients in Tel Aviv taking a slightly higher dosage than those in the U.S. PrimeC is a combination of two drugs, Celecoxib and Ciprofloxacin, which work synergistically to target neuroinflammation and RNA metabolism pathologies.

NeuroSense is excited about PrimeC’s potential to help ALS patients.


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