Corcept Announces Results From Phase 2 Study Of Dazucorilant In Patients With Amyotrophic Lateral Sclerosis; DAZALS Did Not Meet Its Primary Endpoint, Which Was The Change From Baseline In The ALS Functional Rating Scale-Revised In Patients Who...
Corcept Announces Results From Phase 2 Study Of Dazucorilant In Patients With Amyotrophic Lateral Sclerosis; DAZALS Did Not Meet Its Primary Endpoint, Which Was The Change From Baseline In The ALS Functional Rating Scale-Revised In Patients Who...
Corcept Announces Results From Phase 2 Study Of Dazucorilant In Patients With Amyotrophic Lateral Sclerosis; DAZALS Did Not Meet Its Primary Endpoint, Which Was The Change From Baseline In The ALS Functional Rating Scale-Revised In Patients Who Received Dazucorilant Compared To Those Who Received Placebo
Corcept公佈了對肌萎縮性側索硬化症患者進行達祖可裏蘭的2期研究結果；DAZALS未達到其主要終點，即接受達祖可利蘭治療的患者與接受安慰劑的患者相比，經修訂的ALS功能評級量表與基線的變化
Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic, and neurologic disorders by modulating the effects of the hormone cortisol, today announced results from the DAZALS study, a randomized, double-blind, placebo-controlled, Phase 2 trial evaluating two doses (150 mg and 300 mg) of its proprietary selective cortisol modulator dazucorilant in patients with ALS. Upon completion of the trial, patients were eligible to enter an open-label, long-term extension study, in which they received 300 mg of dazucorilant.
Corcept Therapeutics Incorporated（納斯達克股票代碼：CORT）是一家處於商業階段的公司，致力於通過調節激素皮質醇的作用來發現和開發治療嚴重內分泌、腫瘤、代謝和神經系統疾病的藥物。DAZALS研究是一項隨機、雙盲、安慰劑對照的2期試驗，評估其專有的選擇性皮質醇的兩劑量（150 mg和300 mg）ALS 患者的 tisol 調節劑 dazucorilant。試驗完成後，患者有資格參加一項開放標籤的長期延期研究，在該研究中，他們接受了300 mg的dazucorilant。
DAZALS did not meet its primary endpoint, which was the change from baseline in the ALS Functional Rating Scale-Revised (ALSFRS-R) in patients who received dazucorilant compared to those who received placebo. Patients who received dazucorilant experienced substantially more gastrointestinal upset at the onset of treatment than those who received placebo. During the 24-week study, no deaths (0/83) were observed in the 300 mg arm, compared to 5 deaths (5/82) in the placebo group (p-value: 0.02). The open-label, long-term extension study will continue and overall survival will be assessed in March 2025 after all patients have had one year pass since the onset of treatment. Dazucorilant has been granted Fast Track Designation by the U.S. Food and Drug Administration.
DAZALS未達到其主要終點，即接受達珠利蘭治療的患者與接受安慰劑的患者相比，ALS功能評級量表修訂版（ALSFRS-R）與基線的變化。與接受安慰劑的患者相比，接受達珠可利蘭治療的患者在開始治療時出現的胃腸道不適要嚴重得多。在這項爲期24周的研究中，300毫克組沒有觀察到死亡（0/83），而安慰劑組中有5例死亡（5/82）（p值：0.02）。這項開放標籤的長期延期研究將繼續進行，在所有患者自開始治療以來已經過了一年之後，將在2025年3月評估總體存活率。Dazucorilant 已被美國食品藥品監督管理局授予快速通道稱號。
Complete results from the DAZALS study will be presented at a medical conference next year.
DAZALS研究的完整結果將在明年的醫學會議上公佈。