On Tuesday, Spruce Biosciences, Inc. (NASDAQ:SPRB) revealed topline results from its CAHmelia-204 study of tildacerfont in adult CAH and its CAHptain-205 study of tildacerfont in adult and pediatric CAH.
Congenital adrenal hyperplasia (CAH) is a genetic disease that affects the adrenal glands and prevents the production of hormones like cortisol, aldosterone, and androgens.
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"In the interim, the CAHmelia-204 and CAHptain-205 clinical trials will be discontinued, and we will be winding down Spruce's investment in tildacerfont for the treatment of CAH as we conserve financial resources and look to maximize shareholder value," said Javier Szwarcberg, CEO of Spruce.
CAHmelia-204 was a Phase 2b trial that evaluated the safety and efficacy of tildacerfont in reducing supraphysiologic GC usage in 100 adults with classic CAH on a mean glucocorticoid (GC) dose of 35mg/day of hydrocortisone equivalents (HCe) (19mg/m2/day) and mean androstenedione (A4) level of 214 ng/dL at baseline.
The clinical trial did not achieve the primary efficacy endpoint of the absolute change in daily GC dose from baseline at week 24. 200mg QD of tildacerfont demonstrated a placebo-adjusted reduction from baseline in a daily GC dose of 0.7mg HCe.
Approximately 98% of patients were highly compliant with the study drug. Tildacerfont was generally safe and well tolerated, with no serious adverse events (SAEs).
CAHptain-205 was a Phase 2 trial that evaluated the safety, pharmacodynamics (changes in A4 levels), and pharmacokinetics of QD and BID doses of tildacerfont from 50mg QD to 400mg BID in pediatric and adult patients with CAH.
A trend of larger reductions from baseline in A4 levels with higher BID doses of tildacerfont was observed.
Tildacerfont was generally safe and well tolerated across all doses, with no drug-related SAEs.
Price Action: SPRB stock is down 23.40% at $0.41 during the premarket session at last check Wednesday.
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