Neurocrine announces CAHtalyst Phase 3 study met primary endpoint

Neurocrine Biosciences announced that the primary study results from its CAHtalyst Phase 3 study investigating crinecerfont for the treatment of adults ages 18 and older with congenital adrenal hyperplasia, CAH, due to 21-hydroxylase deficiency have been published in The New England Journal of Medicine online edition and will appear in a future print issue of the journal. The study met the primary and important key secondary endpoints related to androgen reduction and glucocorticoid dose reduction while maintaining androgen control. Favorable trends were observed with endpoints that reflect the consequences of long-term supraphysiologic glucocorticoid therapy. The Phase 3 Adult study met the primary endpoint of percent change from baseline in GC dose and the key secondary endpoint of achievement of reduction to a physiologic GC dose at Week 24. Crinecerfont treatment led to a significantly greater GC dose reduction at Week 24 while maintaining androstenedione control compared to placebo. This corresponded to changes of -4.8 and -2.1 mg/m2/day hydrocortisone equivalents for crinecerfont and placebo, respectively After the initial 4-week GC stable period, mean percent GC reduction was greater with crinecerfont than placebo at all timepoints, and this effect was maintained from Weeks 12 to 24, while GC levels increased from Weeks 12 to 24 for participants on placebo.