Neurocrine Biosciences, Inc. announced the initiation of a Phase 1 first-in-human clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of investigational compound NBIP-01435 in healthy adult participants. NBIP-01435 is a long-acting corticotropin-releasing factor type 1 receptor antagonist administered as a subcutaneous injection.
This compound is being developed for the potential treatment of congenital adrenal hyperplasia (CAH). This marks the first investigational peptide from Neurocrine's biologics pipeline to proceed to the clinic, signaling an expansion of the company's therapeutic modalities.
Neurocrine has exclusive rights to develop and commercialize NBIP-01435 from a research collaboration with Sentia Medical Sciences, Inc. CRF1 antagonism has been shown to improve androgen control and allow for lower, more physiological glucocorticoid dosing regimens for patients with CAH, complementing the recently approved oral CRF1 antagonist, crinecerfont.
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