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宣布了针对肌萎缩侧索硬化症患者的Dazucorilant二期研究结果；DAZALS未能满足其主要终点，该终点是接受Dazucorilant的患者与接受安慰剂的患者在ALS功能评分量表修订版的基线变化。
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医疗公司（纳斯达克：CORT）是一家商业阶段公司，致力于发现和开发用于治疗严重内分泌、肿瘤、代谢和神经疾病的药物，通过调节激素皮质醇的影响，今天宣布了DAZALS研究的结果，这是一个随机、双盲、安慰剂对照的二期试验，评估其专有选择性皮质醇调节剂dazucorilant在ALS患者中两种剂量（150 mg和300 mg）的效果。在试验完成后，患者有资格进入一个开放标签的长期延续研究，在该研究中他们接受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未能满足其主要终点，即接受dazucorilant的患者与接受安慰剂的患者在ALS功能评分量表修订版（ALSFRS-R）基线变化。接受dazucorilant的患者在治疗开始时经历了显著更多的胃肠不适，相比之下，接受安慰剂的患者较少。在24周的研究中，300 mg组没有观察到死亡（0/83），而安慰剂组则有5例死亡（5/82）（p值：0.02）。开放标签的长期延续研究将继续进行，整体生存将在2025年3月评估，届时所有患者自治疗开始已有一年时间。Dazucorilant已获得美国食品和药物管理局的快速通道资格。
Complete results from the DAZALS study will be presented at a medical conference next year.
DAZALS研究的完整结果将在明年的医学会议上进行发布。
