MENLO PARK, Calif., April 08, 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 ROSELLA, a pivotal Phase 3 trial of its proprietary selective cortisol modulator relacorilant combined with nab-paclitaxel in patients with recurrent, platinum-resistant ovarian cancer..

加利福尼亚州门洛帕克，2024年4月8日（环球通讯社）--Corcept Therapeutics Incorporated（NASDAQ:CORT），一家商业阶段公司，致力于通过调节激素皮质醇的作用来发现和开发治疗严重内分泌，肿瘤，代谢和神经系统疾病的药物，今天宣布完成ROSELLA的注册，ROSELLA是其专有选择性皮质醇调节剂相关剂联合nab-紫杉醇治疗复发性铂类耐药卵巢癌患者的关键3期试验。。

“Fully enrolling ROSELLA takes us a big step closer to addressing the unmet medical need of women with platinum-resistant ovarian cancer,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “Relacorilant has the potential to become the standard of care for patients with this devastating disease.

Corcept首席开发官、PharmD BillGuyer说：“完全注册ROSELLA使我们离解决铂类耐药卵巢癌女性未满足的医疗需求又近了一大步。”。“Relacorilant有可能成为这种毁灭性疾病患者的标准护理。

We expect progression-free survival data, ROSELLA’s primary endpoint, by the end of this year.”.

我们预计到今年年底，ROSELLA的主要终点无进展生存数据。”。

The ROSELLA trial has the same design as Corcept's positive Phase 2 study, in which patients who received relacorilant intermittently – the day before, the day of and the day after they received nab-paclitaxel – exhibited improvements in progression-free survival, duration of response and overall survival compared to patients who received nab-paclitaxel alone, without an increased side effect burden.

ROSELLA试验的设计与Corcept的阳性2期研究相同，在该研究中，间歇性接受relacorilant治疗的患者（接受nab-paclitaxel的前一天，第二天和第二天）与单独接受nab-paclitaxel的患者相比，无进展生存期，反应持续时间和总生存期有所改善，而副作用负担没有增加。

These results were published in the Journal of Clinical Oncology in June 2023..

这些结果发表在2023年6月的《临床肿瘤学杂志》上。。

The ROSELLA trial enrolled 381 women at sites in the United States, Europe, South Korea, Brazil, Argentina, Canada and Australia. Patients were randomized 1:1 to receive either relacorilant dosed intermittently with nab-paclitaxel or nab-paclitaxel monotherapy. ROSELLA’s primary endpoint is progression-free survival.

ROSELLA试验在美国、欧洲、韩国、巴西、阿根廷、加拿大和澳大利亚招募了381名女性。患者以1:1的比例随机接受间歇性给予nab-紫杉醇或nab-紫杉醇单药治疗的相关药物。ROSELLA的主要终点是无进展生存期。

Overall survival is a key secondary endpoint..

总体生存率是一个关键的次要终点。。

About Platinum-Resistant Ovarian Cancer

关于铂类耐药卵巢癌

Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns less than six months after receiving platinum-containing therapy have “platinum-resistant” disease. There are few treatment options and median overall survival following recurrence is 12 months or less with single-agent chemotherapy.1 In the United States, approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year..

卵巢癌是女性癌症死亡的第五大常见原因。接受含铂治疗后不到六个月病情复发的患者患有“铂耐药”疾病。治疗选择很少，单药化疗复发后的中位总生存期为12个月或更短。1在美国，每年约有20000名患有铂类耐药疾病的女性有望开始新的治疗。。

About Relacorilant

关于Relarelant

Relacorilant is a selective cortisol modulator that binds to the glucocorticoid receptor (GR), but does not bind to the body's other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders, including ovarian, adrenal and prostate cancer and Cushing’s syndrome. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents..

Relacorilant是一种选择性皮质醇调节剂，与糖皮质激素受体（GR）结合，但不与身体其他激素受体结合。Corcept正在研究多种严重疾病的相关性，包括卵巢癌、肾上腺癌、前列腺癌和库欣综合征。Relacorilant是Corcept的专利，受物质成分、使用方法和其他专利的保护。。

About Corcept’s Oncology Programs

关于Corcept的肿瘤学计划

Cortisol activity allows solid tumors that express the GR to resist treatment. In some cancers, cortisol inhibits cellular apoptosis — the tumor-killing effect many treatments are meant to stimulate. In other cancers, cortisol activity promotes tumor growth. Cortisol also suppresses the body’s immune response, weakening the body’s ability to fight certain cancers.

皮质醇活性允许表达GR的实体瘤抵抗治疗。在一些癌症中，皮质醇抑制细胞凋亡-许多治疗方法旨在刺激这种肿瘤杀伤作用。在其他癌症中，皮质醇活性促进肿瘤生长。皮质醇还抑制身体的免疫反应，削弱身体对抗某些癌症的能力。

Modulating cortisol’s activity may reduce these adverse effects and help anti-cancer treatments achieve their intended effect..

调节皮质醇的活性可以减少这些不良反应，并帮助抗癌治疗达到预期效果。。

Corcept is conducting clinical trials of its proprietary compound, relacorilant, in combination with three different anti-cancer treatments in patients with ovarian, adrenal and prostate cancers.

Corcept正在对其专有化合物relacorilant进行临床试验，并结合卵巢癌、肾上腺癌和前列腺癌患者的三种不同抗癌治疗方法。

About Corcept Therapeutics

关于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).

25年来，Corcept专注于皮质醇调节及其治疗各种严重疾病患者的潜力，导致发现了1000多种专有选择性皮质醇调节剂。Corcept的高级临床试验正在皮质醇增多症、实体瘤、肌萎缩侧索硬化症（ALS）和肝病（NASH）患者中进行。

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..

2012年2月，该公司推出了Korlym，这是美国食品和药物管理局批准用于治疗库欣综合征患者的第一种药物。Corcept总部位于加利福尼亚州门洛帕克。有关更多信息，请访问Corcept.com。。

Forward-Looking Statements

前瞻性声明

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 include, but are not limited to, our ability to operate our business; risks related to the study and development of Korlym as well as relacorilant, miricorilant, dazucorilant and our other product candidates, including their clinical attributes, regulatory approvals, mandates, oversight and other requirements; and the scope and protective power of our intellectual property.

本新闻稿中的声明（历史事实声明除外）是基于我们当前计划和预期的前瞻性声明，这些声明具有风险和不确定性，可能导致我们的实际结果与这些声明明示或暗示的结果存在重大差异。这些风险和不确定性包括但不限于我们经营业务的能力；与Korlym以及relacorilant，miricorilant，dazucorilant和我们的其他候选产品的研究和开发相关的风险，包括其临床属性，监管批准，授权，监督和其他要求；以及我们知识产权的范围和保护能力。

These and other risks are set forth in our SEC filings, which are available at our website and the SEC’s website..

这些和其他风险在我们的SEC文件中有规定，这些文件可在我们的网站和SEC的网站上找到。。

In this press release, forward-looking statements include those concerning the conduct, pace and outcome of our Phase 3 ROSELLA trial in patients with ovarian cancer, as well as the development of relacorilant as a treatment for other solid tumors, Cushing’s syndrome and other indications, including relacorilant’s clinical attributes, regulatory approvals, mandates, oversight, and other requirements; the potential for relacorilant plus nab-paclitaxel to become a standard of care for patients with recurrent, platinum-resistant ovarian cancer or to otherwise meet their unmet medical needs.

在本新闻稿中，前瞻性声明包括关于我们在卵巢癌患者中进行的3期ROSELLA试验的行为，速度和结果，以及relacorilant作为其他实体瘤，库欣综合征和其他适应症的治疗方法的发展，包括relacorilant的临床属性，监管批准，授权，监督和其他要求；relacorilant加nab紫杉醇有可能成为复发性铂类耐药卵巢癌患者的标准治疗方法，或以其他方式满足其未满足的医疗需求。

We disclaim any intention or duty to update forward-looking statements made in this press release..

我们不打算或有义务更新本新闻稿中的前瞻性声明。。

1Therapeutic Advances in Medical Oncology (Luvero et al. 2014)

1医学肿瘤学的治疗进展（Luvero等人，2014）

CONTACT

联系人

Investor inquiries:

投资者咨询：

ir@corcept.com

ir@corcept.com

Media inquiries:

媒体查询：

communications@corcept.com

communications@corcept.com

www.corcept.com

www.corcept.com