Published on 24 Mar 2024 on Zacks via Yahoo Finance
Spruce Biosciences SPRB stock has declined 86.1% in the past month due to the failure of a key study on its lead pipeline candidate, tildacerfont.
Spruce Biosciences is developing tildacerfont in the CAHmelia program as a non-steroidal, once-daily therapy for patients suffering from classic congenital adrenal hyperplasia (CAH). The CAHmelia program in adult classic CAH comprises two phase IIb studies. The first study is CAHmelia-203, which assesses androstenedione (A4 - a steroid hormone) reduction in adult CAH patients with severe hyperandrogenemia, a difficult-to-treat CAH patient population.
Last week, Spruce Biosciences announced that the CAHmelia-203 phase IIb study of tildacerfont in adult patients with CAH failed to meet the primary efficacy endpoint of change in A4 from baseline to week 12. In the study, a 200mg once-daily dose of tildacerfont demonstrated a placebo-adjusted reduction of -2.6% in A4 at week 12, which was not statistically significant. Spruce Biosciences said the negative outcome of the study was due to poor treatment compliance.