US clinical-stage pharma company Spruse Biosciences (Nasdaq: SPRB) announced disappointing top-line results from its CAHmelia-203 study of tildacerfont in adult classic congenital adrenal hyperplasia (CAH) and its CAHptain-205 study of tildacerfont in pediatric classic CAH, with the news sending the firm’s shares plunging a massive 76% to $1.25 in pre-market activity.
Spruse revealed that the clinical trial did not achieve the primary efficacy endpoint of the assessment of dose response for the change in A4 from baseline to week 12.
200mg QD of tildacerfont demonstrated a placebo-adjusted reduction from baseline in A4 of -2.6% at week 12 with a non-significant p-value.
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