Neurocrine Biosciences, Inc. announced today that it has suspended two planned clinical studies of the Company’s CRF antagonist NBI-77860. “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,” said Chris O’Brien, M.D., Chief Medical Officer at Neurocrine. “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 two clinical studies that were halted include a single dose study in adolescent females with classic congenital adrenal hyperplasia and a multiple dose study in adults with classic congenital adrenal hyperplasia. The Company had not enrolled any subjects in either study and accordingly, there have been no adverse events reported.
The Company has also been informed by the FDA that the NBI-77860 clinical development program would be placed on partial clinical hold.
Source: Neurocrine Biosciences
Filed Under: Drug Discovery
