Germany’s Federal Institute for Drugs and Medical Devices approved NeuroSense Therapeutics’ (NASDAQ:NRSN) clinical trial application to enroll patients in PARADIGM, a Phase 2b study of its lead combination drug candidate PrimeC in the treatment of amyotrophic lateral sclerosis (ALS).
PARADIGM is a randomized, multi-center, multinational, prospective, double-blind, placebo-controlled study, with an open-label extension, to evaluate the safety, tolerability, and efficacy of PrimeC. To date, over 50% of the planned 69 study participants have been enrolled.
“We expect to enroll the first study participant in Germany in the next few weeks,” Dr. Ferenc Tracik, CMO of NeuroSense, said in a statement. “We are currently on track to complete enrollment and report data in the second half of this year.”