Crinetics Pharmaceuticals Inc. (CRNX) has dosed the first patient in its Phase 2/3 trial of investigational drug Atumelnant for the treatment of classic congenital adrenal hyperplasia in children and adolescents, dubbed BALANCE-CAH.
Atumelnant is Crinetics' once-daily oral adrenocorticotropic hormone (ACTH) receptor antagonist candidate in late-stage development, designed to block the adrenal gland pathway that leads to excess androgen production in classic CAH.
High levels of androgens can manifest as reduced fertility in men and women, excessive facial hair and acne in women, and painful testicular adrenal rest tumours in men.
Atumelnant has received FDA Orphan Drug designation for the proposed treatment of classic congenital adrenal hyperplasia, following positive topline results from the Phase 2 TouCAHn trial in adults with the condition.
The Phase 2 TouCAHn study demonstrated sustained reductions of key biomarkers across doses, including up to an 80% mean reduction in androstenedione, an androgen.
The BALANCE-CAH Phase 2/3 trial will study atumelnant in pediatric patients with CAH and will evaluate safety, efficacy, and pharmacokinetics in children and adolescents, a population with significant unmet medical need.
The study is structured in three phases - Part A will be a Phase 2, open-label, semi-sequential dose-ranging portion of the study. Part B is the Phase 3, double-blind, randomised, placebo-controlled confirmatory portion of the study. Part C is an open-label extension portion of the study.
Recently, on September 25th, CRNX's lead product, PALSONIFY (palatine), was approved by the FDA as a once-daily oral treatment for adults with acromegaly, based on its PATHFNDR-1 and PATHFNDR-2 Phase 3 pivotal trials.
Crinetics' clinical-stage pipeline programs include CRN09682, a nonpeptide drug conjugate (NDC) targeting somatostatin receptor 2 (SST2) expressed in neuroendocrine tumours and other solid tumours.
The company's early-stage discovery pipeline includes small molecules for treating thyroid eye disease/Graves' disease, hyperparathyroidism, polycystic kidney disease, obesity and other endocrinology indications
CRNX has traded in a range of $24.10 to $57.99 in the last 1 year. The stock closed Thursday's trading at $54.95 down 0.83%.
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