Penny Stock Spruce Biosciences Winds Down Tildacerfont Studies For Rare Genetic Disorder
Penny Stock Spruce Biosciences Winds Down Tildacerfont Studies For Rare Genetic Disorder
"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.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.
在周二，Spruce Biosciences, Inc. (纳斯达克:SPRB) 揭示了其 CAHmelia-204 成人 CAH 的 tildacerfont 研究的顶线结果，以及其 CAHptain-205 成人和儿童 CAH 的 tildacerfont 研究。
Congenital adrenal hyperplasia (CAH) is a genetic disease that affects the adrenal glands and prevents the production of hormones like cortisol, aldosterone, and androgens.
先天性肾上腺增生 (CAH) 是一种遗传性疾病，会影响肾上腺，并阻止产生皮质醇、醛固酮和雄激素等激素。
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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.
“在此期间，CAHmelia-204 和 CAHptain-205 临床试验将被停止，我们将逐步减少 Spruce 在 tildacerfont 上的投资，以治疗 CAH，同时时我们将节省财务资源并寻求最大化股东价值，” Spruce 的首席执行官 Javier Szwarcberg 说。
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.
CAHmelia-204 是一项 Phase 20亿 试验，评估 tildacerfont 在100名经典 CAH 成人中减少超生理糖皮质激素使用的安全性和有效性，这些患者的平均糖皮质激素 (GC) 剂量为每日 35mg 氢化可的松当量 (HCe) (每日 19mg/m2) 和基线时平均雄烯二醇 (A4) 水平为 214 ng/dL。
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.
该临床试验未达到主要有效性终点，即在第24周与基线相比每日 GC 剂量的绝对变化。每日200mg的tildacerfont显示出从基线的0.7mg HCe的安慰剂调整减少。
Approximately 98% of patients were highly compliant with the study drug. Tildacerfont was generally safe and well tolerated, with no serious adverse events (SAEs).
大约98%的患者对研究药物的依从性很高。tildacerfont 通常安全且耐受良好，没有严重不良事件 (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.
CAHptain-205 是一项 Phase 2 试验，评估 tildacerfont 从每日50mg到每日400mg的QD和BID剂量在儿童和成人 CAH 患者中的安全性、药效学（A4水平的变化）和药代动力学。
A trend of larger reductions from baseline in A4 levels with higher BID doses of tildacerfont was observed.
在较高的tildacerfont买盘剂量下，观察到A4水平从基线的大幅减少趋势。
Tildacerfont was generally safe and well tolerated across all doses, with no drug-related SAEs.
tildacerfont在所有剂量下通常是安全且耐受良好的，没有与药物相关的严重不良事件。
Price Action: SPRB stock is down 23.40% at $0.41 during the premarket session at last check Wednesday.
价格动作：SPRb股票在周三的盘前交易中下跌了23.40%，目前价格为0.41美元。
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