Spruce Biosciences' Hormone Treatment Stumbles In Trials, Prompts Stock Freefall

Spruce Biosciences Inc SPRB shares plummeted on Thursday after the company released topline results from its CAHmelia-203 Phase 2b study of tildacerfont in adult classic congenital adrenal hyperplasia (CAH) and its CAHptain-205 study of tildacerfont in pediatric classic CAH.

The CAHmelia-203 study did not achieve the primary efficacy endpoint of the assessment of dose response for the change in A4 from baseline to week 12.

The preliminary pharmacokinetic analysis of the CAHptain-205 study suggests that tildacerfont is cleared more rapidly in children than in adult CAH patients.

HC Wainwright notes that despite considering tildacerfont an active drug, the setback in the CAHmelia-203 trial has created uncertainty about its future development and regulatory submission timeline. 

Consequently, they are downgrading their rating on the shares from Buy to Neutral, with no specified price target. They await more clarity on tildacerfont’s long-term prospects and the results of the upcoming CAHmelia-204 trial, which is expected to release data later this year.

RBC Capital Markets said that while tildacerfont was well-tolerated, its efficacy and clinical profile were questionable due to a lack of reported dose-response and low compliance, leading to lower-than-expected exposure. 

They highlighted upcoming milestones for CAHmelia-204 and suggested strategic dosing options, along with longer pivotal intentions for data from trials 204 and 205. However, they emphasized the need for a deeper understanding of the drug and its target patient population. 

RBC downgraded its price target from $9 to $2 and shifted to a Sector Perform from Outperform.

JMP Securities noted that Tildacerfont did not demonstrate any significant effect on A4, likely due to poor compliance with medication and/or insufficient dosage, compounded by a challenging patient population, thus highlighting the importance of considering compliance issues in future assessments.

JMP Securities lowered its price target from $8 to $3 to maintain a Market Outperform rating. 

Price Action: SPRB shares fell 84.38% to 81 cents on Thursday.

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Image created using artificial intelligence with Midjourney.