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宣佈了針對肌萎縮側索硬化症患者的Dazucorilant二期研究結果；DAZALS未能滿足其主要終點，該終點是接受Dazucorilant的患者與接受安慰劑的患者在ALS功能評分量表修訂版的基線變化。
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醫療公司（納斯達克：CORT）是一家商業階段公司，致力於發現和開發用於治療嚴重內分泌、腫瘤、代謝和神經疾病的藥物，通過調節激素皮質醇的影響，今天宣佈了DAZALS研究的結果，這是一個隨機、雙盲、安慰劑對照的二期試驗，評估其專有選擇性皮質醇調節劑dazucorilant在ALS患者中兩種劑量（150 mg和300 mg）的效果。在試驗完成後，患者有資格進入一個開放標籤的長期延續研究，在該研究中他們接受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未能滿足其主要終點，即接受dazucorilant的患者與接受安慰劑的患者在ALS功能評分量表修訂版（ALSFRS-R）基線變化。接受dazucorilant的患者在治療開始時經歷了顯著更多的胃腸不適，相比之下，接受安慰劑的患者較少。在24周的研究中，300 mg組沒有觀察到死亡（0/83），而安慰劑組則有5例死亡（5/82）（p值：0.02）。開放標籤的長期延續研究將繼續進行，整體生存將在2025年3月評估，屆時所有患者自治療開始已有一年時間。Dazucorilant已獲得美國食品和藥物管理局的快速通道資格。
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進行發佈。
譯文內容由第三人軟體翻譯。
