Spruce Biosciences announced the European Medicines Agency (EMA) has granted orphan drug designation for SPR001 for the treatment of congenital adrenal hyperplasia (CAH).
Spruce also received orphan drug designation for SPR001 from the U.S. Food and Drug Administration (FDA).
"The granting of orphan drug designation by both the EMA and FDA represents an important step forward for our lead product candidate, and underscores the high unmet medical need for developing new therapies that may benefit patients living with congenital adrenal hyperplasia," said Dr. Alexis Howerton, CEO, Spruce Biosciences.
Spruce is currently in a Phase 2 clinical trial to assess the safety and efficacy of SPR001 in adults with classic CAH. This study is enrolling at centers across the U.S., with topline data expected in 2018.