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益普生在美容领域的LANTIC II期为IPN10200提供一流的差异化长效临床特征

Ipsen’s LANTIC Phase II in aesthetics delivers a first-in-class, differentiated long-acting clinical profile for IPN10200, enabling the initiation of Phase III

益普生 等信源发布 2025-09-22 13:11

可切换为仅中文


– Ipsen (Euronext: IPN; ADR: IPSEY) today announced the first aesthetic data (n=183) for glabellar lines with internally developed IPN10200, following Stage 1 of the multi-stage, ongoing Phase II LANTIC trial. Patients treated with IPN10200 showed a statistically significant improvement in response at Week 4 vs placebo (primary endpoint).

– 益普生(Euronext: IPN;ADR: IPSEY)今天宣布了在多阶段、正在进行的II期LANTIC试验的第一阶段后,使用内部开发的IPN10200针对眉间纹的首个美学数据(n=183)。接受IPN10200治疗的患者在第4周显示出相较于安慰剂的统计学显著改善(主要终点)。

A longer duration of effect was also observed with a substantial majority of patients experiencing a clinically significant response at Week 24 compared with placebo and Dysport, defined as a score of “none” or “mild”. IPN10200 continued to show a greater response in line severity vs Dysport at Week 36.

在第24周,与安慰剂和Dysport相比,绝大多数患者表现出临床显著反应,定义为“无”或“轻度”评分,效果持续时间更长。在第36周,IPN10200在皱纹严重程度方面继续显示出比Dysport更大的改善。

In this trial Dysport was shown to perform consistently with its profile. .

在此试验中,Dysport 表现与其特性一致。

“The data demonstrates that we have a first-in-class, unique molecule with the potential to be a breakthrough innovation in aesthetics, demonstrating truly longer duration versus an established botulinum A for glabellar lines,” said David Loew, CEO of Ipsen. “Today’s announcement is an important milestone for Ipsen as we advance our pipeline and underscores our commitment and expertise, built on a more than 30-year legacy in Neuroscience.” .

“数据显示,我们拥有一个首屈一指的、独特的分子,有潜力在美学领域成为突破性创新,与已确立的A型肉毒杆菌相比,展现出更持久的效果,”益普生首席执行官大卫·洛说。“今天的公告对益普生来说是一个重要的里程碑,因为我们正在推进我们的研发管线,并彰显了我们在神经科学领域超过30年的传承所建立的承诺与专长。”

“IPN10200’s novel design, derived from active sequence part A and binding sequence part B, is optimized for safety and efficacy. Uniquely engineered to deliver increased receptor affinity and internalization IPN10200 has shown this clinically significant long duration of effect, experienced for the first time by a substantial majority of patients at Week 24.” said Christelle Huguet, PhD, EVP and Head of R&D, Ipsen.

“IPN10200 的新颖设计源自活性序列部分 A 和结合序列部分 B,经过优化以提高安全性和有效性。IPN10200 通过独特的工程设计实现了更高的受体亲和力和内化能力,在第 24 周时,绝大多数患者首次体验到了这种具有临床意义的长效作用。”益普生研发执行副总裁兼负责人 Christelle Huguet 博士表示。

“These data are reinforced by the rapid onset of action and superior patient satisfaction scores vs placebo and vs Dysport. We are committed to advancing science with purpose to bring the benefits patients are looking for, as we believe everyone deserves a life fully lived. .

“这些数据得到了快速起效和优于安慰剂及Dysport的患者满意度评分的支持。我们致力于以目标为导向推进科学,为患者带来他们所期望的益处,因为我们相信每个人都值得拥有充实的生活。”

IPN10200 has shown a statistically significant improvement in response compared to placebo, as measured by the primary endpoint of composite response of 2-grade improvement on both Investigator and Subject assessment of line severity at Week 4, consistent with peak effect observed with Dysport. A longer duration of effect was also observed with a substantial majority of patients experiencing a clinically significant response, defined as a score of “none” or “mild” as measured by Investigator assessment of line severity, at Week 24 compared with placebo and with Dysport.

IPN10200在主要终点指标上显示出比安慰剂有统计学意义的显著改善,该指标为第4周时研究者和受试者对皱纹严重程度评估均有2级改善的综合反应,这与Dysport观察到的峰值效应一致。在第24周时,与安慰剂和Dysport相比,绝大多数患者表现出更长的疗效持续时间,并且在临床上有显著反应,定义为研究者对皱纹严重程度评估得分为“无”或“轻度”。

Patient diary data showed a rapid onset of action with IPN10200. .

患者日记数据显示,IPN10200起效迅速。

IPN10200 was shown to be well-tolerated with no safety concerns reported with any of the evaluated doses of IPN10200 across Stage 1. Data will be shared in a scientific conference in the first half of 2026 and activities for our global Phase III program in glabellar lines have been initiated. The LANTIC trial remains ongoing, with Stage 2 currently recruiting patients to evaluate the efficacy and safety of IPN10200 compared with placebo in forehead lines or lateral canthal lines.

IPN10200在第一阶段的所有评估剂量中均显示出良好的耐受性,未报告任何安全性问题。数据将在2026年上半年的科学会议上分享,同时我们针对眉间纹的全球III期项目活动已经启动。LANTIC试验仍在进行中,第二阶段目前正在招募患者,以评估IPN10200相较于安慰剂在额头纹或鱼尾纹中的疗效和安全性。

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About IPN10200

关于 IPN10200

IPN10200 is Ipsen’s first-in-class recombinant molecule, uniquely engineered to combine active sequence part A and binding sequence part B. Designed for enhanced receptor affinity and internalization, IPN10200 delivered a longer and clinically significant duration of effect. The molecule has been optimized for safety and efficacy and is being evaluated across four Phase II trials in both aesthetic and therapeutic indications.

IPN10200是益普生公司首创的重组分子,经过独特设计,将活性序列部分A与结合序列部分B相结合。该分子旨在增强受体亲和力和内化作用,IPN10200展现了更长且具有临床意义的作用持续时间。该分子已经过安全性与疗效优化,目前正在四项II期试验中针对美容和治疗适应症进行评估。

About LANTIC

关于LANTIC

LANTIC (n=727) a Phase I/II trial evaluating the safety and efficacy of IPN10200 in three aesthetic indications of moderate to severe upper facial lines: glabellar lines, forehead lines and lateral canthal lines, across 3 Stages. Stage 1 includes patients evaluating safety and efficacy of IPN10200 in a dose finding and dose escalation stage in glabellar lines, with three defined steps including multiple doses of IPN10200; dose-escalation (step 1: Phase Ib), dose finding vs placebo and vs Dysport (step 2: Phase II) and additional dose finding vs placebo and vs Dysport (step 3: Phase II).

LANTIC(n=727)是一项I/II期临床试验,评估IPN10200在三种中至重度上面部线条美学适应症中的安全性和有效性:眉间线、额纹和鱼尾纹,分为三个阶段。第一阶段包括患者在眉间线中进行剂量探索和剂量递增阶段的安全性和有效性评估,包含三个明确步骤,涉及IPN10200的多剂量给药;剂量递增(步骤1:Ib期)、与安慰剂及Dysport对比的剂量探索(步骤2:II期),以及额外的与安慰剂及Dysport对比的剂量探索(步骤3:II期)。

Different doses of IPN10200 were evaluated within each step. Step 3 is the basis of the proof-of-concept data for IPN10200 in glabellar lines including 183 patients. Stages 2 and 3 (Phase II) will evaluate IPN10200 in all three upper facial indications vs placebo. The LANTIC trial is one of several ongoing trials within Ipsen’s broader IPN10200 development programs.

在每个步骤中评估了不同剂量的IPN10200。第3步是IPN10200在眉间线的概念验证数据的基础,包括183名患者。第2和第3阶段(II期)将评估IPN10200在所有三个上脸部适应症中与安慰剂的对比。LANTIC试验是Ipsen更广泛的IPN10200开发计划中的几个正在进行的试验之一。

About Ipsen

关于益普生

We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience.

我们是一家全球生物制药公司,专注于在三个治疗领域为患者带来变革性药物:肿瘤学、罕见病和神经科学。

Our pipeline is fueled by internal and external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 100 countries..

我们的产品线由内外部创新提供动力,并受到近100年的发展经验以及在美国、法国和英国的全球中心的支持。我们在40多个国家/地区的团队和世界各地的合作伙伴关系使我们能够将药物带给100多个国家/地区的患者。

Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com

益普生在巴黎(泛欧交易所:IPN)和美国通过一级赞助美国存托凭证计划(ADR:IPSEY)上市。欲了解更多信息,请访问 ipsen.com。