Regeneron Pharmaceuticals, Inc. REGN and Sanofi SA‘s SNY Phase 3 LIBERTY-CUPID Study C of Dupixent (dupilumab) was successful.

Regeneron Pharmaceuticals，Inc.REGN和Sanofi SA的Dupixent（dupilumab）的SNY 3期LIBERTY-CUPID研究C取得了成功。

The study met the primary and key secondary endpoints for uncontrolled, biologic-naïve chronic spontaneous urticaria (CSU) receiving background therapy with antihistamines.

该研究符合接受抗组胺药背景治疗的不受控制的，生物学上幼稚的慢性自发性荨麻疹（CSU）的主要和关键次要终点。

CSU is a chronic skin condition that causes hives and persistent itch. The positive trial confirms results from Study A, the first Phase 3 trial of Dupixent in this setting.

CSU是一种慢性皮肤病，会导致荨麻疹和持续瘙痒。阳性试验证实了研究A的结果，这是Dupixent在这种情况下的第一个3期试验。

Also Read: Regeneron Pharmaceuticals’ Q2 Earnings Exceed Estimates, Driven By Its Top-Selling Eczema And Eye Drugs.

另请阅读：Regeneron Pharmaceuticals第二季度的收益超过预期，这是由于其畅销湿疹和眼部药物。

Earlier this year, Japan was the first country in the world to approve and launch Dupixent for adult and adolescent CSU patients based on the results from Study A.

今年早些时候，根据研究A的结果，日本是世界上第一个批准并推出针对成年和青少年CSU患者的Dupixent的国家。

At 24 weeks, efficacy among patients receiving Dupixent compared to placebo was as follows:

在24周时，与安慰剂相比，接受Dupixent治疗的患者的疗效如下：

8.64-point reduction in itch severity from baseline with Dupixent versus a 6.10-point reduction with placebo.

。

Dupixent reduced the severity of urticaria activity (itch and hive) by 15.86 points from baseline compared to 11.21 points with placebo.

Dupixent将荨麻疹活动（瘙痒和荨麻疹）的严重程度从基线降低了15.86分，而安慰剂组为11.21分。

30% of Dupixent-treated patients reported no urticaria (complete response) compared to 18% of placebo patients.

30%的Dupixent治疗患者报告没有荨麻疹（完全缓解），而安慰剂患者为18%。

Detailed results from this trial will be provided to the FDA by year-end 2024 in response to the additional data requested for inclusion in the supplemental biologics license application for Dupixent in CSU after rejection in October 2023.

该试验的详细结果将在2024年底之前提供给FDA，以回应2023年10月被拒绝后要求纳入CSU Dupixent补充生物制剂许可证申请的额外数据。

Concurrently, Regeneron Pharmaceuticals and Sanofi announced that a Dupixent (dupilumab) ADEPT Phase 2/3 trial in bullous pemphigoid met the primary and all key secondary endpoints.

同时，Regeneron Pharmaceuticals和赛诺菲宣布，Dupixent（dupilumab）ADEPT 2/3期大疱性类天疱疮试验符合主要和所有关键次要终点。

Five times more Dupixent patients achieved sustained disease remission in the trial than placebo patients.

在试验中，Dupixent患者的疾病持续缓解率是安慰剂患者的五倍。

For the primary endpoint, 20% of Dupixent patients experienced sustained disease remission at 36 weeks compared to 4% for placebo (p=0.0114).

对于主要终点，20%的Dupixent患者在36周时经历了持续的疾病缓解，而安慰剂组为4%（p=0.0114）。

Sustained disease remission was defined as complete clinical remission with completion of oral corticosteroids (OCS) taper by week 16 without relapse and no rescue therapy use during the 36-week treatment period.

持续疾病缓解被定义为完全临床缓解，在第16周完成口服皮质类固醇（OCS）减量，在36周的治疗期间没有复发，也没有使用救援治疗。

For the components comprising the primary endpoint – with patients having to achieve all components – efficacy among patients receiving Dupixent compared to placebo was as follows:

对于构成主要终点的成分（患者必须达到所有成分），与安慰剂相比，接受Dupixent治疗的患者的疗效如下：

The absence of disease relapse after the patient completed the OCS taper was 59% vs. 16%.

患者完成OCS减量后没有疾病复发的比例为59%比16%。

Absence of need for rescue therapy during the treatment period: 42% vs. 12%.

治疗期间不需要救援治疗：42%比12%。

Achievement of complete remission and off OCS by week 16: 38% vs. 27% (not significant).

在第16周达到完全缓解和脱离OCS:38%比27%（不显着）。

Additionally, a small separate Phase 3 trial (Study A) of Dupixent in adults with uncontrolled and severe chronic pruritus of unknown origin did not achieve statistical significance in its primary itch responder endpoint but showed nominally significant improvements in all other itch endpoints.

此外，Dupixent在成人中进行的一项小型单独的3期临床试验（研究a）对不明原因的不受控制和严重慢性瘙痒症患者的主要瘙痒反应终点没有统计学意义，但在所有其他瘙痒终点上均显示出名义上的显着改善。

The Dupixent Phase 3 program in CPUO consists of Study A and Study B. Study B is planned to initiate as a subsequent pivotal trial.

CPUO的Dupixent 3期项目由研究A和研究B组成。研究B计划作为后续的关键试验启动。

Price Action: REGN stock closed at $1,136.35, and SNY stock closed at $58.08 on Tuesday.

价格走势：REGN股票周二收于1136.35美元，SNY股票周二收于58.08美元。

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