Neurocrine Biosciences 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, or 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% from baseline in 17-hydroxyprogesterone, or 17-OHP, and adrenocorticotropic hormone, or ACTH, levels in more than 50% 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 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.
https://thefly.com/landingPageNews.php?id=2877741
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