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.
在週二，Spruce Biosciences, Inc. (納斯達克:SPRB) 揭示了其 CAHmelia-204 成人 CAH 的 tildacerfont 研究的頂線結果，以及其 CAHptain-205 成人和兒童 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.
先天性腎上腺增生 (CAH) 是一種遺傳性疾病，會影響腎上腺，並阻止產生皮質醇、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.
「在此期間，CAHmelia-204 和 CAHptain-205 臨床試驗將被停止，我們將逐步減少 Spruce 在 tildacerfont 上的投資，以治療 CAH，同時時我們將節省財務資源並尋求最大化股東價值，」 Spruce 的首席執行官 Javier Szwarcberg 說。
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 是一項 Phase 20億 試驗，評估 tildacerfont 在100名經典 CAH 成人中減少超生理糖皮質激素使用的安全性和有效性，這些患者的平均糖皮質激素 (GC) 劑量爲每日 35mg 氫化可的松當量 (HCe) (每日 19mg/m2) 和基線時平均雄烯二醇 (A4) 水平爲 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.
該臨床試驗未達到主要有效性終點，即在第24周與基線相比每日 GC 劑量的絕對變化。每日200mg的tildacerfont顯示出從基線的0.7mg HCe的安慰劑調整減少。
Approximately 98% of patients were highly compliant with the study drug. Tildacerfont was generally safe and well tolerated, with no serious adverse events (SAEs).
大約98%的患者對研究藥物的依從性很高。tildacerfont 通常安全且耐受良好，沒有嚴重不良事件 (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 是一項 Phase 2 試驗，評估 tildacerfont 從每日50mg到每日400mg的QD和BID劑量在兒童和成人 CAH 患者中的安全性、藥效學（A4水平的變化）和藥代動力學。
A trend of larger reductions from baseline in A4 levels with higher BID doses of tildacerfont was observed.
在較高的tildacerfont買盤劑量下，觀察到A4水平從基線的大幅減少趨勢。
Tildacerfont was generally safe and well tolerated across all doses, with no drug-related SAEs.
tildacerfont在所有劑量下通常是安全且耐受良好的，沒有與藥物相關的嚴重不良事件。
Price Action: SPRB stock is down 23.40% at $0.41 during the premarket session at last check Wednesday.
價格動作：SPRb股票在週三的盤前交易中下跌了23.40%，目前價格爲0.41美元。
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譯文內容由第三人軟體翻譯。
