Spruce Biosciences withdraws from Tildacerfont development: results disappoint investors

Spruce Biosciences has released the interim results of the CAHmelia-204 and CAHptain-205 studies investigating the drug Tildacerfont for congenital adrenal hyperplasia (CAH). The genetic disorder affects hormone production in the adrenal glands and poses a challenge for treatment. In a strategic move, CEO Javier Szwarcberg announced that clinical trials would be suspended, and the company would scale back its investments in Tildacerfont. The aim is to preserve financial resources and maximize shareholder value. The Phase 2b CAHmelia-204 study aimed to evaluate the safety and efficacy of the drug in reducing the glucocorticoid dosage. The primary efficacy targets could not be achieved. Although the treatment was well tolerated, Tildacerfont only achieved a marginal reduction in the daily glucocorticoid dosage. The concurrently conducted CAHptain-205 study also included pediatric patients and examined the effects of different dosages of Tildacerfont on androstenedione levels. Here, too, the drug was safe and well tolerated, but without significant results. In response to the disappointing study results, Spruce Biosciences' stock fell 23.40% and was last quoted at $0.41 in pre-market trading.