Crinetics announces initial findings for atumelnant in two ongoing studies

Crinetics Pharmaceuticals announced initial findings from the development program of its second clinical product candidate, atumelnant, a novel, once-daily oral adrenocorticotropic hormone receptor antagonist. The results, presented at the Endocrine Society’s annual meeting, include initial data from the Phase 1b/2a, open-label study in participants with ACTH-dependent Cushing’s syndrome conducted in collaboration with the National Institutes of Health, and the Phase 2 open-label TouCAHn study in participants with congenital adrenal hyperplasia.”Despite knowing about ACTH’s pivotal role in the endocrine stress response for nearly a century, no other ACTH antagonist drug candidates have been developed and studied in humans. Achieving physiologically normal hormone levels is critical for people living with CAH and ADCS, and today’s data show an impressive ability of atumelnant to reduce key disease drivers like A4 or cortisol to healthy levels,” said Scott Struthers, Ph.D., founder and CEO of Crinetics. “These data also reinforce the strength of our in-house discovery engine and our ability to purposefully design medicines with groundbreaking mechanisms of action like atumelnant, the second novel drug candidate in our pipeline to have demonstrated remarkable results in clinical studies.” Initial results from Cohort 1: Atumelnant resulted in profound, rapid and sustained reductions in key adrenal steroids that are hallmarks of CAH. 100% of participants had A4 levels below the upper limit of normal at two weeks with atumelnant, which was sustained through 12 weeks. Two-week data from the first four patients in Cohort 2 (40 mg atumelnant once daily) are also presented at ENDO2024. No severe or serious treatment emergent adverse events have been observed to date, and no participants have discontinued from the trial. All AEs to-date have been mild to moderate and transient. There were no significant changes in safety labs or electrocardiograms. The most common treatment-emergent adverse events included: fatigue, headache and upper respiratory tract infection.