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Crinetics Announces First Patient Dosed in Pivotal Adult Trial of Atumelnant in Congenital Adrenal Hyperplasia (CAH)
Phase 3 study builds on positive phase 2 results showing rapid and sustained reductions in key disease biomarkers and clinical measures of CAH SAN DIEGO, Dec.
About this update from Crinetics Pharmaceuticals, Inc.
[{"type":"text","content":"Phase 3 study builds on positive phase 2 results showing rapid and sustained reductions in key disease biomarkers and clinical measures of CAH\nSAN DIEGO, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced that the first patient has been dosed in the CALM-CAH Phase 3 trial evaluating investigational candidate atumelnant, a novel, once-daily, oral adrenocorticotropic hormone (ACTH) receptor antagonist candidate for the proposed treatment of classic congenital adrenal hyperplasia (CAH). “Dosing the first patient in this Phase 3 study underscores our commitment to addressing the unmet needs of people living with CAH and our excitement about the potential of atumelnant,” said Dana Pizzuti, M.D., Chief Medical and Development Officer of Crinetics. “Through the CALM-CAH study, we will evaluate atumelnant’s ability to normalize adrenal androgen levels while simultaneously reducing glucocorticoid levels to the physiologically normal range. With a unique endpoint measuring both of these objectives, CALM-CAH sets a new standard in terms of assessing overall disease control.” Atumelnant is the first-and-only small molecule ACTH receptor antagonist in late-stage clinical development and is designed to block the pathway in the adrenal gland that leads to the production of excess androgens associated with classic CAH. In a Phase 2 study in adults with classic CAH, treatment with atumelnant was associated with reductions in key biomarkers, including androstenedione and 17-hydroxyprogesterone, as well as other clinical measures of disease activity including adrenal size and resumption of menses. Based on Phase 2 results, Crinetics has advanced the registrational CALM-CAH Phase 3 trial in adults. The CALM-CAH Phase 3 study is a randomized, placebo-controlled trial evaluating atumelnant in adults with classic CAH, designed to assess reductions in excess androgens, improvements in glucocorticoid use, and other clinical outcomes that reflect disease control. Crinetics recently received Orphan Drug Designation from the U.S. Food & Drug Administration (FDA) for atumelnant in the treatment of classic CAH. For more information, visit https://clinicaltrials.gov/study/NCT07159841. About AtumelnantInvestigational atumelnant is the first in class and only once-daily, oral adrenocorticotropic hormone (ACTH) rece...