The FDA has granted Regenerative Medicine Advanced Therapy designation to NouvNeu001, a cell therapy for Parkinson’s disease.
NouvNeu001, developed by iRegene, is the first allogeneic cell therapy globally to hold both RMAT and Fast Track designations, according to a Jan. 19 company news release. The therapy is designed to replace lost dopaminergic neurons and restore dopamine production in patients with Parkinson’s disease, the second most common neurodegenerative disorder worldwide.
Phase 1 clinical trial data showed motor function improvements of up to 52.82% in the low-dose group and 54.67% in the ON-medication state at 12 months. Benefits were sustained through 15 months post-treatment.
The drugmaker plans to expand its pipeline of cell-based treatments targeting multiple system atrophy, early-onset Parkinson’s and retinal degeneration, with additional products in clinical or preclinical stages.
