Neurocrine presents baseline data of CAH program

Neurocrine and Diurnal, a Neurocrine Biosciences company, presented baseline data from the CAHtalyst Phase 3 studies of crinecerfont in adult and pediatric patients with congenital adrenal hyperplasia or CAH, and modified-release hydrocortisone or Chronocort data for a Phase 2 clinical study in participants with primary adrenal insufficiency and in a Phase 3 extension study in CAH. These data were presented at the European Congress of Endocrinology 2024 meeting in Stockholm. “At baseline, many participants in the CAHtalyst Pediatric study showed clinical evidence of elevated glucocorticoid doses and adrenal androgen excess. Many exhibited obesity, advanced bone age, and early puberty, all of which can negatively impact development in childhood and adolescence,” said Eiry Roberts, Chief Medical Officer. “Baseline characteristics in the CAHtalyst Phase 3 study in adults saw this trend continue. Despite being in their 30s, many of the CAHtalyst Adult study participants have been diagnosed with disorders that are more common in people twice their age, including osteopenia, hypertension and hyperlipidemia. In both studies, adrenal androgen and other steroid markers were elevated at baseline despite supraphysiologic doses of glucocorticoids, demonstrating the need for novel glucocorticoid-independent approaches to reducing adrenal androgens and supraphysiologic glucocorticoid dosing in CAH patients at all ages.” The Phase 2 study for modified-release hydrocortisone in adults with adrenal insufficiency demonstrated participants achieved physiological morning cortisol levels after 4 weeks. Phase 3 extension study data for modified-release hydrocortisone in adults with CAH demonstrated reduction in median daily hydrocortisone dose and an increase in responders at levels less than or equal to 25 mg/day.