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Neurocrine Announces Interim Results From Phase II Study Of NBI-74788

Neurocrine Biosciences Inc. (NBIX) announced positive interim results from a Phase II proof-of-concept study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of NBI-74788, a proprietary corticotropin-releasing factor type 1 (CRF1) receptor antagonist, in adult patients with classic congenital adrenal hyperplasia (CAH).

The results from this ongoing Phase II open-label study demonstrated a reduction of at least 50 percent from baseline in 17-hydroxyprogesterone (17-OHP) and adrenocorticotropic hormone (ACTH) levels in more than 50 percent of CAH patients treated with NBI-74788 for 14 days.

Meaningful reductions were also observed in other biomarkers, including androstenedione. NBI-74788 was shown to be well tolerated with no serious adverse events reported to date.

The company said it plans to meet with the FDA to discuss the registration program for NBI-74788 in adult and pediatric patients with CAH, a genetic disorder affecting the adrenal glands.

Classic CAH is a rare genetic disorder caused by a deficiency of the 21-hydroxylase enzyme, which alters the production of cortisol and other adrenal steroids, leading to adrenal insufficiency, overgrowth of the adrenal glands, and excess androgen levels. Classic CAH can lead to adrenal crisis, virilization, hirsutism, precocious puberty, fertility problems and abnormal growth. The standard of care for classic CAH requires a lifelong regimen with high-dose corticosteroids, which cause additional serious long-term clinical problems, including bone loss, Cushing's syndrome and metabolic issues.

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