Corvus Pharmaceuticals宣布了Soquelitinib治疗特应性皮炎的安慰剂对照1期临床试验第三组的完整数据-动脉网

Corvus Pharmaceuticals Announces Full Data from Cohort 3 of Placebo-Controlled Phase 1 Clinical Trial of Soquelitinib for Atopic Dermatitis

Corvus Pharma 等信源发布 2025-06-04 07:00

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可切换为仅中文

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Cohort 3 demonstrates earlier and deeper responses compared to cohorts 1-2

队列3显示出比队列1和2更早和更深的反应。

All three cohorts show separation from placebo with statistically significant difference from placebo at day 28

所有三个队列在第28天均显示出与安慰剂的分离，并且与安慰剂相比具有统计学上的显著差异。

Cohort 3 demonstrates clinically meaningful reduction in itch as early as day 8

第3组患者在第8天就显示出临床上有意义的瘙痒减轻。

Enrollment initiated in extension cohort study exploring the same cohort 3 dose (200 mg BID) for a longer 8-week treatment period

扩展队列研究中开始招募，探索同一队列3剂量（200 mg BID）长达8周的治疗期。

SOUTH SAN FRANCISCO, Calif.

加利福尼亚州南旧金山

，

June 04, 2025

2025年6月4日

(GLOBE NEWSWIRE) --

（环球新闻社）——

Corvus Pharmaceuticals, Inc.

Corvus制药公司

(NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced new interim data from the randomized, double-blind, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis. The data includes 28-day follow up results for all patients in cohort 3 and continues to show earlier and deeper responses in cohort 3 (200 mg twice per day, total daily dose 400 mg) compared to cohorts 1 and 2 (100 mg twice per day and 200 mg once per day, total daily dose 200 mg).

(NASDAQ: CRVS)是一家临床阶段的生物制药公司，今天宣布了新的中期数据，这些数据来自一项随机、双盲、安慰剂对照的1期临床试验，评估了soquelitinib在中度至重度特应性皮炎患者中的效果。数据包括队列3中所有患者的28天随访结果，并继续显示队列3（每天两次200毫克，总日剂量400毫克）相较于队列1和队列2（每天两次100毫克和每天一次200毫克，总日剂量200毫克）更早和更显著的反应。

Overall, data from cohorts 1-3 of the trial have demonstrated a favorable safety and efficacy profile, including a statistically significant improvement in Eczema Area and Severity Index (EASI) score for the soquelitinib treated patients compared to placebo at day 28 (p=0.036)..

总体而言，试验第1-3组的数据展示了良好的安全性和有效性，包括在第28天时，与安慰剂相比，接受soquelitinib治疗的患者在湿疹面积和严重程度指数（EASI）评分上有统计学意义上的显著改善（p=0.036）。

“The complete 28-day data from cohort 3 of our Phase 1 trial of soquelitinib in patients with atopic dermatitis is in-line with the data update we provided at the

“我们第一阶段试验的第三组患者使用soquelitinib治疗特应性皮炎的完整28天数据与我们之前提供的数据更新一致，该数据在”

Society for Investigative Dermatology

调查性皮肤病学学会

meeting last month,” said

上个月的会议，”他说

Richard A. Miller

理查德·A·米勒

, M.D., co-founder, president and chief executive officer of Corvus. “We are encouraged that results from cohort 3 continue to show earlier and deeper responses, along with a reduction in itch, which is an important factor for patients. We look forward to exploring the potential for further improvement in patient results with longer treatment duration that is being studied in our recently initiated extension cohort.

医学博士，Corvus公司联合创始人、总裁兼首席执行官表示：“我们感到鼓舞的是，第三组的结果继续显示出更早和更深层次的反应，同时瘙痒也有所减轻，这是患者的一个重要因素。我们期待在最近启动的扩展队列中研究治疗时间延长对患者结果进一步改善的潜力。”

Overall, the data to date is supportive of our view that ITK inhibition with soquelitinib has the potential to be a safe, effective and convenient new option for patients with atopic dermatitis and other immune diseases.”.

总体而言，迄今为止的数据支持我们的观点，即使用soquelitinib进行ITK抑制有可能成为特应性皮炎和其他免疫疾病患者安全、有效且方便的新选择。"

Dr. Miller

米勒博士

will highlight the new interim data in a presentation at the

将在以下演示中突出显示新的中期数据

Jefferies Global Healthcare Conference

杰富瑞全球医疗保健会议

, which is scheduled for

，计划于

9:20 am ET

早上9点20分（美国东部时间）

6:20 am PT

早上6点20分（太平洋时间）

打开

Thursday, June 5, 2025

2025年6月5日，星期四

. The live webcast, which will include presentation slides, may be accessed via the

现场直播的网络广播，包含演示幻灯片，可以通过以下方式访问

investor relations

投资者关系

section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days.

Corvus网站的部分内容。网络广播的重播将在Corvus的网站上提供90天。

Soquelitinib Interim Data from the Atopic Dermatitis Phase 1 Clinical Trial

Soquelitinib 特应性皮炎1期临床试验的中期数据

As of

截至

May 28, 2025

2025年5月28日

, enrollment in cohorts 1, 2 and 3 has been completed for a total of 48 patients and all patients (36 receiving soquelitinib and 12 placebos) had completed the 28-day treatment course. Patients in cohort 3 had more advanced disease with a higher mean baseline

，第1、2和3组的入组已完成，共48名患者，所有患者（36名接受soquelitinib，12名接受安慰剂）均完成了28天的治疗疗程。第3组的患者疾病更为晚期，基线平均值较高。

EASI

易的

score compared to patients in cohorts 1 and 2. At 28 days, the mean reduction in

与队列1和队列2中的患者相比的评分。在28天时，平均减少量为

EASI

易损性评估系统

for cohort 3 (n=12) was 64.8%, compared to 54.6% for cohort 1 and 2 combined (n=24) and 34.4% for placebo (n=12).

第三组（n=12）为64.8%，相比之下，第一组和第二组合并（n=24）为54.6%，安慰剂组（n=12）为34.4%。

The graphs below (Figures 1 and 2) show the kinetics of response for each of the cohorts and for the combined cohorts 1, 2 and 3. The placebo patients (n=4 per cohort, total n=12) are combined in both graphs. Separation of the curves for patients receiving active drug began at day 15 and increased by day 28 for cohorts 1 and 2.

以下图表（图1和图2）显示了每个队列以及合并的队列1、2和3的反应动力学。安慰剂组患者（每队列n=4，总计n=12）在两张图表中均被合并。接受活性药物的患者的曲线从第15天开始分离，并在第28天时队列1和2的分离进一步增大。

Cohort 3 patients experienced earlier and deeper separation from placebo starting by day 8. .

第三组患者从第8天开始经历比安慰剂组更早且更深的分离效果。

EASI

易学易用（EASI）

scores continue to improve further in treated patients from all cohorts out to day 58.

所有队列中接受治疗的患者的评分持续提高，直至第58天。

Figure 1: Percent Reduction in Mean EASI Score for Cohorts 1, 2 and 3

图1：第1、2和3组平均EASI评分的百分比降低

. Mean percent change in

. 平均百分比变化

EASI

易学易用

score over time is shown. Treatment beginning is designated “Baseline” and days post-baseline are shown. Screening to baseline data is shown and demonstrates relative disease stability. The study blinding remains in effect for the entire 58-day period. Numbers at the top of the graphs indicate numbers of patients evaluated at the various time points..

随时间变化的评分已显示。治疗开始被指定为“基线”，并显示了基线后的天数。筛选到基线的数据已显示，表明疾病相对稳定。研究的盲法在整整58天期间一直有效。图表顶部的数字表示在各个时间点评估的患者数量。

Figure 2: Percent Reduction in Mean EASI Score for Combined Cohorts 1, 2 and 3.

图2：合并队列1、2和3的平均EASI评分的百分比降低。

The data is displayed below with cohorts combined.

下方显示的是合并队列后的数据。

Figure 3 below shows the percent of patients that achieved IGA (Investigator Global Assessment) 0 or 1 or

图3显示了达到IGA（研究者全球评估）0或1的患者百分比，或者

EASI

易 купить

75 at day 28 of treatment. The placebo patients from cohort 1 (n=4), cohort 2 (n=4) and cohort 3 (n=4) are combined, with no placebo patients achieving IGA 0 or 1 or

治疗第28天达到75。将第一组（n=4）、第二组（n=4）和第三组（n=4）的安慰剂患者合并，没有安慰剂患者达到IGA 0或1或

EASI

易损性指数评估

75. IGA 0 or 1 and EASI 75 have been determined by the U.S. Food and Drug Administration (FDA) to be clinically meaningful and approvable endpoints and have been the endpoints used in clinical trials for other FDA approved treatments for atopic dermatitis. Four additional patients in cohort 3 are now included in the results as compared to the data reported at the .

75. IGA 0 或 1 和 EASI 75 已被美国食品和药物管理局 (FDA) 认定为具有临床意义且可批准的终点，并且已被用于其他 FDA 批准的特应性皮炎治疗的临床试验终点。与此前在会议上报告的数据相比，队列 3 中新增了四名患者纳入结果。

Society for Investigative Dermatology

调查性皮肤病学学会

(SID) annual meeting in

(SID)年度会议在

May 2025

2025年5月

(SID data was as of

(SID 数据截至

May 6

5月6日

; these four patients had not yet completed the 28-day treatment course). One of the four patients achieved

；这四名患者尚未完成 28 天的治疗过程）。其中一名患者达到了

EASI

易学易用

75 (this patient experienced an 89% reduction in

75（该患者经历了89%的减少

EASI

易

score) and IGA 1 at day 28 of treatment.

得分）以及治疗第28天的IGA 1。

Figure 3: Percent Patients Achieving Endpoints IGA 0 or 1, EASI 75 at Day 28 of Treatment

图3：治疗第28天达到终点IGA 0或1、EASI 75的患者百分比

Patient Reported Reductions in Itch

患者报告的瘙痒减轻

Patients in the trial recorded the intensity of their pruritus, or itch, using the Peak Pruritus Numerical Rating Scale (PP-NRS), which rates the severity of itch on a scale from 0 (no itch) to 10 (the worst itch imaginable). A reduction of ≥4 points from baseline on the PP-NRS is considered to be a clinically meaningful result.

试验中的患者使用峰值瘙痒数字评定量表（PP-NRS）记录了他们的瘙痒强度，该量表将瘙痒的严重程度从0（无瘙痒）到10（可以想象的最严重瘙痒）进行评分。PP-NRS评分较基线降低≥4分被认为具有临床意义。

In cohort 3, of the patients for whom adequate PP-NRS data was available, 4 of 8 (50%) had a ≥4 point reduction in PP-NRS score from baseline at day 28, with a reduction in itch seen as early as day 8. Of the remaining patients, two had baseline PP-NRS of less than 4 and two had incomplete PP-NRS data.

在队列3中，在那些有足够的PP-NRS数据的患者中，8人中有4人（50%）在第28天时PP-NRS评分较基线降低了至少4分，瘙痒的减轻最早在第8天就已显现。在其余患者中，两人基线PP-NRS评分低于4分，两人PP-NRS数据不完整。

1 of 10 evaluable placebo patients (10%) experienced a ≥4 point reduction in PP-NRS score at Day 28..

在第28天，10名可评估的安慰剂患者中有1名（10%）PP-NRS评分减少了≥4分。

Safety Data

安全数据

As of

截至

May 28, 2025

2025年5月28日

, no new safety signals have been observed. Soquelitinib was well tolerated, with no dose limiting toxicities (DLTs) and no clinically significant laboratory abnormalities observed in any of the cohorts. No interruption of drug dosing was seen in any of the cohorts. Grade 1/2 adverse events (treatment related and unrelated) were seen in 38.9% of patients receiving soquelitinib and 25% receiving placebo.

，未观察到新的安全信号。Soquelitinib 耐受性良好，没有任何一组中出现剂量限制性毒性（DLTs）或有临床意义的实验室异常。所有组均未出现药物剂量中断的情况。接受Soquelitinib治疗的患者中有38.9%和接受安慰剂治疗的患者中有25%出现了1/2级不良事件（与治疗相关及无关）。

Only one treatment related adverse event of grade 1 nausea was reported with soquelitinib treatment..

仅报告了一例与Soquelitinib治疗相关的1级恶心不良事件。

Serum Cytokine and Other Biomarker Studies

血清细胞因子及其他生物标志物研究

As reported previously, relationships between reductions in certain cytokines with improvement in

正如之前报道的，某些细胞因子的减少与改善之间的关系

EASI

易学易用

scores were observed. Reductions in serum cytokine levels were seen for IL-5, IL-9, IL-17, IL-31, IL-33, TSLP and TARC. Differences between responding and non-responding patients were found, while no such relationships were seen in the placebo group, and patients in cohort 3 had greater reductions in cytokines compared to cohorts 1 and 2.

观察到了评分变化。血清细胞因子水平的降低见于IL-5、IL-9、IL-17、IL-31、IL-33、TSLP和TARC。在应答患者和非应答患者之间发现了差异，而在安慰剂组中未见此类关系，队列3的患者相比队列1和队列2细胞因子的降低幅度更大。

Increasing trends were seen in numbers of circulating T regulatory cells, consistent with the presumed mechanism of action of soquelitinib..

循环 T 调节细胞数量呈增加趋势，这与 soquelitinib 的推定作用机制一致。

Soquelitinib Atopic Dermatitis Phase 1 Clinical Trial Extension Cohort

Soquelitinib 特应性皮炎一期临床试验扩展队列

Corvus also announced that the first patient(s) has/have been enrolled in the recently announced extension cohort of the Phase 1 trial. This cohort is planned to enroll 24 patients randomized 1:1 between active and placebo, with patients in the treatment group receiving the same dose as cohort 3 – 200 mg orally twice per day.

Corvus还宣布，第一名患者已经加入到最近宣布的1期试验的扩展队列中。该队列计划招募24名患者，随机分为活性药物组和安慰剂组，比例为1:1，治疗组的患者将接受与队列3相同的剂量——每天口服两次200毫克。

The treatment period for this group is 8 weeks, compared to 4 weeks in cohorts 1-3, with the same 30-day follow-up period with no treatment..

该组的治疗期为8周，而第1-3组为4周，同样的30天随访期且不进行治疗。

About Corvus Pharmaceuticals

关于Corvus制药公司

Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company pioneering the development of ITK inhibition as a new approach to immunotherapy for a broad range of cancer and immune diseases. The Company’s lead product candidate is soquelitinib, an investigational, oral, small molecule drug that selectively inhibits ITK.

Corvus Pharmaceuticals是一家临床阶段的生物制药公司，率先开发ITK抑制作为一种针对多种癌症和免疫疾病的新免疫疗法。该公司的主要候选产品是soquelitinib，一种研究性口服小分子药物，可选择性抑制ITK。

Its other clinical-stage candidates are being developed for a variety of cancer indications. For more information, visit .

其其他临床阶段的候选药物正在被开发用于各种癌症适应症。欲了解更多信息，请访问。

www.corvuspharma.com

or follow the Company on

或在以下平台关注公司

领英

。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements related to the potential of the Company’s product candidates including soquelitinib and the potential for further improvement in patient results in the extension cohort of the Phase 1 trial of soquelitinib in patients with atopic dermatitis, the design and planned enrollment of the extension cohort, data in support of ITK inhibition with soquelitinib and its potential for patients, and continued advancement of the Company’s clinical pipeline.

本新闻稿包含与公司产品候选物（包括soquelitinib）潜力相关的前瞻性声明，以及soquelitinib在特应性皮炎患者1期试验扩展队列中患者结果可能进一步改善的潜力、扩展队列的设计与计划招募、支持soquelitinib对ITK抑制的数据及其对患者的潜力，以及公司临床管线的持续推进。

All statements other than statements of historical fact contained in this press release are forward-looking statements. These statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company’s control.

本新闻稿中包含的所有非历史事实的声明均为前瞻性声明。这些声明通常包括“相信”、“预期”、“预计”、“打算”、“计划”、“估计”、“寻求”、“将”、“可能”或类似表述。前瞻性声明受制于多种风险和不确定性，其中许多涉及公司无法控制的因素或情况。

The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Quarterly Report on Form 10-Q for the quarter ended .

由于多种因素，公司的实际结果可能与前瞻性陈述中所述或暗示的结果存在重大差异，这些因素包括但不限于公司在截至该季度的10-Q表季度报告中详述的风险。

March 31, 2025

2025年3月31日

, filed with the

，提交给

Securities and Exchange Commission

证券交易委员会

在

May 8, 2025

2025年5月8日

, as well as other documents that may be filed by the Company from time to time with the

以及公司不时向

Securities and Exchange Commission

证券交易委员会

. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of its product candidates; the accuracy of the Company’s estimates relating to its ability to initiate and/or complete preclinical studies and clinical trials and release data from such studies and clinical trials; the results of preclinical studies and interim data from clinical trials not being predictive of future results; the Company’s ability to enroll sufficient numbers of patients in its clinical trials; the unpredictability of the regulatory process; regulatory developments in .

特别是，以下因素（包括但不限于）可能导致实际结果与这些前瞻性声明中明示或暗示的结果存在重大差异：公司在其产品候选物的临床试验中证明足够有效性和安全性的能力；公司对其启动和/或完成临床前研究和临床试验并发布相关数据的能力的估计准确性；临床前研究结果和临床试验中期数据不能预测未来结果；公司在其临床试验中招募足够数量患者的能力；监管过程的不可预测性；监管动态的发展。

the United States

美国

and foreign countries; the costs of clinical trials may exceed expectations; and the Company’s ability to raise additional capital. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements.

以及外国国家；临床试验的成本可能超出预期；以及公司筹集额外资本的能力。尽管公司认为前瞻性陈述中反映的预期是合理的，但不能保证前瞻性陈述中反映的事件和情况将会实现或发生，事件和情况的时间安排及实际结果可能与前瞻性陈述中的预测有重大差异。

Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise..

因此，你不应过分依赖这些前瞻性陈述。所有这些陈述仅截至作出之日有效，公司不承担公开更新或修订任何前瞻性陈述的义务，无论是由于新信息、未来事件或其他原因。

INVESTOR CONTACT:

投资者联系方式：

Leiv Lea

莱夫·莱亚

Chief Financial Officer

首席财务官

Corvus Pharmaceuticals, Inc.

Corvus制药公司

+1-650-900-4522

llea@corvuspharma.com

MEDIA CONTACT: