Corcept Completes Enrollment in Phase 2 DAZALS Trial in Patients With Amyotrophic Lateral Sclerosis (ALS)
Corcept Completes Enrollment in Phase 2 DAZALS Trial in Patients With Amyotrophic Lateral Sclerosis (ALS)
MENLO PARK, Calif., April 15, 2024 (GLOBE NEWSWIRE) -- 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 completion of enrollment in DAZALS, a randomized, double-blind, placebo-controlled Phase 2 trial of its proprietary selective cortisol modulator dazucorilant in patients with amyotrophic lateral sclerosis (ALS).
加利福尼亞州門洛帕克，2024年4月15日（GLOBE NEWSWIRE）——Corcept Therapeutics Incorporated（納斯達克股票代碼：CORT）是一家商業階段的公司，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，今天宣佈完成隨機、雙盲、安慰劑對照階段的DAZALS的註冊其專有的選擇性皮質醇調節劑dazucorilant在肌萎縮性側索硬化症（ALS）患者中的2項試驗。
DAZALS enrolled 249 patients, randomized 1:1:1 to receive either 150 mg of dazucorilant, 300 mg of dazucorilant or placebo daily for 24 weeks. The study's primary endpoint is change from baseline in the ALS Functional Rating Scale-Revised (ALSFRS-R), which measures motor impairment and functional deterioration in patients with ALS. Key secondary endpoints include overall survival and quality of life. DAZALS was conducted at sites in Europe, United States and Canada.
DAZALS招收了249名患者，以 1:1:1 的隨機比例接受 150 毫克達珠可利蘭、300 毫克達珠可利蘭或安慰劑，持續 24 周。該研究的主要終點是ALS功能評級量表修訂版（ALSFRS-R）與基線相比的變化，該量表衡量了肌萎縮性側索硬化症患者的運動障礙和功能惡化。關鍵次要終點包括總體存活率和生活質量。DAZALS 是在歐洲、美國和加拿大的地點進行的。
"Better treatments for ALS are urgently needed," said Bill Guyer, PharmD, Corcept's Chief Development Officer. "Dazucorilant showed great promise in an animal model of ALS – improving motor performance and reducing neuroinflammation and muscular atrophy. Fully enrolling DAZALS is an important step toward understanding dazucorilant's potential for significantly improving outcomes for people living with this devastating disease. We expect data by the end of this year."
Corcept首席開發官PharmD的比爾·蓋爾說：“迫切需要更好的肌萎縮性側索硬化症治療方法。”“Dazucorilant在ALS的動物模型中顯示出巨大的前景——改善運動性能，減少神經炎症和肌肉萎縮。全面註冊DAZALS是了解dazucorilant顯著改善這種毀滅性疾病患者預後的潛力的重要一步。我們預計今年年底會有數據。”
About ALS
ALS, also known as Lou Gehrig's disease, is a fatal degenerative neurologic disorder that affects more than 25,000 people in the United States. ALS causes muscles to weaken and as the disease progresses, severely impairs patients' ability to speak, eat, move and breathe. There is increasing evidence that patients with ALS exhibit elevated or abnormal cortisol levels, particularly those with rapid disease progression. A patient's average life expectancy after diagnosis is two to five years.
關於 ALS
肌萎縮性側索硬化症，也被稱爲盧·格里格氏病，是一種致命的退行性神經系統疾病，在美國有超過25,000人受到影響。肌萎縮性側索硬化症會導致肌肉減弱，隨着疾病的發展，嚴重損害患者的說話、進食、活動和呼吸能力。越來越多的證據表明，肌萎縮性側索硬化症患者的皮質醇水平升高或異常，尤其是那些疾病進展迅速的患者。患者診斷後的平均預期壽命爲兩到五年。
About Dazucorilant
Dazucorilant is a selective cortisol modulator that binds to the glucocorticoid receptor (GR), but does not bind to the body's other hormone receptors. Dazucorilant crosses the blood-brain barrier and Corcept is studying it as a potential treatment for ALS and other neurologic disorders. Dazucorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents.
關於 Dazucorilant
Dazucorilant是一種選擇性皮質醇調節劑，可與糖皮質激素受體（GR）結合，但不與人體的其他激素受體結合。Dazucorilant穿過血腦屏障，Corcept正在研究將其作爲ALS和其他神經系統疾病的潛在治療方法。Dazucorilant是Corcept的專有產品，受物質成分、使用方法和其他專利的保護。
About Corcept Therapeutics
For over 25 years, Corcept's focus on cortisol modulation and its potential to treat patients across a wide variety of serious disorders has led to the discovery of more than 1,000 proprietary selective cortisol modulators. Corcept's advanced clinical trials are being conducted in patients with hypercortisolism, solid tumors, amyotrophic lateral sclerosis (ALS) and liver disease (NASH). In February 2012, the company introduced Korlym, the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with Cushing's syndrome. Corcept is headquartered in Menlo Park, California. For more information, visit Corcept.com.
關於 Corcept Therap
25年來，Corcept專注於皮質醇調節及其治療各種嚴重疾病患者的潛力，這促使人們發現了1,000多種專有的選擇性皮質醇調節劑。Corcept的高級臨床試驗正在對皮質醇增多、實體瘤、肌萎縮性側索硬化（ALS）和肝病（NASH）患者進行。2012年2月，該公司推出了Korlym，這是美國食品藥品監督管理局批准的第一種用於治療庫欣綜合徵患者的藥物。Corcept總部位於加利福尼亞州的門洛帕克。欲了解更多信息，請訪問Corcept.com。
Forward-Looking Statements
Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations that are subject to risks and uncertainties that might cause our actual results to differ materially from those such statements express or imply. These risks and uncertainties are set forth in our SEC filings, which are available at our website and the SEC's website.
前瞻性陳述
除歷史事實陳述外，本新聞稿中的陳述均爲基於我們當前計劃和預期的前瞻性陳述，這些陳述存在風險和不確定性，可能導致我們的實際業績與此類陳述所表達或暗示的存在重大差異。這些風險和不確定性載於我們的美國證券交易委員會文件中，這些文件可在我們的網站和美國證券交易委員會的網站上查閱。
In this press release, forward-looking statements include those concerning: Dazucorilant, including its clinical attributes and potential to become a treatment for patients with ALS or any other disorder, the conduct, pace and outcome of our DAZALS trial, and dazucorilant's potential commercialization. We disclaim any intention or duty to update forward-looking statements made in this press release.
在本新聞稿中，前瞻性陳述包括與以下內容有關的陳述：Dazucorilant，包括其臨床特性和成爲肌萎縮性側索硬化症或任何其他疾病患者治療藥物的可能性，我們的DAZALS試驗的進行、速度和結果，以及dazucorilant的潛在商業化。我們不打算或沒有義務更新本新聞稿中的前瞻性陳述。
CONTACT
Investor inquiries:
ir@corcept.com
Media inquiries:
communications@corcept.com
聯繫
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ir@corcept.com
媒體查詢：
communications@corcept.com
譯文內容由第三人軟體翻譯。