Genetic Technologies(GENE) Benzinga·2024-12-11 13:21Core Insights - Spruce Biosciences, Inc. announced the discontinuation of its CAHmelia-204 and CAHptain-205 clinical trials for tildacerfont in treating congenital adrenal hyperplasia (CAH) to conserve financial resources and maximize shareholder value [1][3]. Group 1: Clinical Trial Results - The CAHmelia-204 trial was a Phase 2b study involving 100 adults with classic CAH, assessing the safety and efficacy of tildacerfont in reducing glucocorticoid (GC) usage [2]. - The trial did not meet its primary efficacy endpoint, showing a placebo-adjusted reduction in daily GC dose of only 0.7mg HCe at week 24 [3]. - Compliance was high, with approximately 98% of patients adhering to the study drug, and tildacerfont was generally safe and well tolerated, with no serious adverse events reported [3][6]. Group 2: Additional Trial Insights - The CAHptain-205 trial evaluated the safety, pharmacodynamics, and pharmacokinetics of tildacerfont in both pediatric and adult patients, with doses ranging from 50mg QD to 400mg BID [4]. - A trend was observed indicating larger reductions in androstenedione (A4) levels with higher BID doses of tildacerfont [5]. - Similar to the CAHmelia-204 trial, tildacerfont was found to be generally safe and well tolerated across all doses, with no drug-related serious adverse events [6]. Group 3: Market Reaction - Following the announcement, Spruce Biosciences' stock price fell by 23.40%, trading at $0.41 during the premarket session [7].