Neurocrine Biosciences' CAHtalyst Phase 3 Studies Of Crinecerfont Meet Primary Goals

(RTTNews) - Neurocrine Biosciences, Inc. (NBIX) Monday said CAHtalyst Pediatric and Adult Phase 3 Studies of Crinecerfont in congenital adrenal hyperplasia (CAH) met primary goals.

Congenital adrenal hyperplasia (CAH) is an inherited disorder of the adrenal glands, which make important hormones.

The CAHtalyst Adult Phase 3 registrational study of Crinecerfont met the primary endpoint and key secondary endpoints related to androgen reduction and glucocorticoid (GC) dose reduction while maintaining androgen control. 62.7 percent of participants treated with Crinecerfont achieved a physiologic glucocorticoid dose while maintaining androstenedione control compared with 17.5 percent of participants treated with placebo.

The Phase 3 Pediatric study met the primary endpoint of change from baseline in androstenedione following the initial 4-week GC-stable period. Thirty percent of participants treated with Crinecerfont achieved a physiologic glucocorticoid dose at week 28 while maintaining androgen control. But this was not achieved in participants who were on placebo. The study also met the key secondary endpoint of percent change from baseline in GC dose.

These results were published in The New England Journal of Medicine online edition.

The company said data from the CAHtalyst Pediatric and CAHtalyst Adult Phase 3 studies supported two New Drug Application submissions to the U.S. Food and Drug Administration in April 2024.