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Congenital adrenal hyperplasia drug trials halted

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Neurocrine Biosciences recently announced suspension of two planned clinical studies of NBI-77860, a selective non-peptide corticotropin releasing factor 1 receptor antagonist with potential for decreasing symptoms of classic congenital adrenal hyperplasia.

The agent was granted orphan drug status by the FDA in January.

“Out of an abundance of caution, we halted the implementation of these studies and notified the FDA of certain recent preclinical findings that we had not observed in previous animal studies," Chris O'Brien, MD, chief medical officer of Neurocrine Biosciences, said in a press release. "We intend to work closely with the FDA to elucidate these findings and determine the next steps for NBI-77860 in congenital adrenal hyperplasia.”

The discontinued studies involved a single-dose trial in adolescent girls and a multiple-dose trial in adults. No participants had been enrolled in either study, and no adverse events have been reported.