Spruce Biosciences reports mixed results in CAH studies

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SOUTH SAN FRANCISCO, Calif. – Spruce Biosciences, Inc. (NASDAQ:SPRB), a biopharmaceutical company focused on rare endocrine disorders, announced mixed topline results from its clinical studies of tildacerfont, a CRF1 receptor antagonist.

The CAHmelia-203 study in adult classic congenital adrenal hyperplasia (CAH) did not meet its primary efficacy endpoint, while the CAHptain-205 study in pediatric CAH showed promise.

The CAHmelia-203 trial, which enrolled 96 adult subjects with severe hyperandrogenemia, aimed to assess the reduction of androstenedione (A4) levels. However, the study did not achieve a statistically significant reduction in A4 levels with a placebo-adjusted drop of -2.6% at week 12.

Low compliance with the study medication and glucocorticoids (GC) was reported, affecting the expected exposure to tildacerfont. Despite the setback, tildacerfont was generally safe and well tolerated with no serious adverse events (SAEs) related to treatment.

In contrast, the CAHptain-205 study in pediatric patients indicated that tildacerfont was safe and well tolerated across all dose ranges without any treatment-related SAEs. Preliminary data showed that 73% of the patients achieved the efficacy endpoint of A4 or GC reduction after 12 weeks of treatment with tildacerfont.

Spruce Biosciences plans to continue exploring dose-ranging in additional cohorts and anticipates topline results in the fourth quarter of 2024. The company also looks forward to the CAHmelia-204 study results in the third quarter of 2024, which will assess GC reduction in adult CAH patients.

In addition to these developments, Spruce Biosciences is implementing cost-saving measures, including discontinuing the CAHmelia-203 study and reducing its workforce by approximately 21%. These changes, along with the company’s current cash reserves, are expected to extend its cash runway through the end of 2025.

The company will hold a conference call today at 4:30 p.m. ET to discuss the clinical study results. These developments are based on a press release statement, and Spruce Biosciences has not provided additional comments on the potential implications of these results.

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