Neurocrine Biosciences Reports Positive Top-line Data From Phase 3 Study Of Crinecerfont

(RTTNews) - Neurocrine Biosciences, Inc. (NBIX) announced Tuesday positive top-line data from the Phase 3 CAHtalyst Adult Study evaluating the efficacy, safety, and tolerability of crinecerfont in adults with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency (21-OHD).

The Phase 3 study met its primary endpoint at Week 24, demonstrating that treatment with crinecerfont resulted in a statistically significant percent reduction in daily glucocorticoid (GC) dose versus placebo while maintaining androgen control.

The study also met important key secondary endpoints, with a statistically significant decrease in androstenedione at Week 4 versus placebo. At Week 24, approximately 63% of patients on crinecerfont achieved a reduction to a physiologic GC dose versus approximately 18% on placebo.

Crinecerfont was generally well tolerated. The most common adverse events during the double-blind, placebo-controlled period of the trial were fatigue, headache, and coronavirus infection. There were few serious adverse events, with none assessed as related to crinecerfont.