Lutris制药将在2025年ESMO胃肠癌大会上展示其LUT014凝胶治疗EGFRI诱导的痤疮样皮疹的二期试验数据-动脉网

Lutris Pharma to Present Data from Its Phase 2 Trial of LUT014 Gel for the Treatment of Patients With EGFRI-Induced Acneiform Rash at the ESMO Gastrointestinal Cancers Congress 2025

CISION 等信源发布 2025-06-17 19:03

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TEL AVIV, Israel

特拉维夫，以色列

，

June 17, 2025

2025年6月17日

/PRNewswire/ --

/美通社/ --

Lutris Pharma

吕特里斯制药

, a clinical stage biopharmaceutical company focused on improving anti-cancer therapies by reducing cutaneous dose limiting toxicity, today announced the presentation of results from its double-blind, placebo-controlled phase 2 randomized clinical trial of lead compound, LUT014 gel. The topically-applied novel B-Raf inhibitor is optimized for paradoxical MAPK activation, for use by patients treated with epidermal growth factor receptor (EGFR) inhibitor therapy who develop dose-limiting acneiform rash.

，一家临床阶段的生物制药公司，专注于通过减少皮肤剂量限制性毒性来改进抗癌疗法，今天宣布了其双盲、安慰剂对照的2期随机临床试验的主要化合物LUT014凝胶的结果。这种外用的新型B-Raf抑制剂针对矛盾性MAPK激活进行了优化，适用于接受表皮生长因子受体（EGFR）抑制剂治疗并出现剂量限制性痤疮样皮疹的患者。

The clinical data will be released in an oral presentation during a Proffered Paper Session at the European Society for Medical Oncology (ESMO) Gastrointestinal Cancers Congress 2025, being held .

临床数据将在2025年欧洲肿瘤内科学会（ESMO）胃肠癌大会的“推荐论文”口头报告环节中发布。

July 2-5

7月2日至5日

在

Barcelona, Spain

西班牙巴塞罗那

。

Presentation Details:

演示详情：

Presentation Title:

演讲标题：

A double-blind placebo-controlled randomized phase 2 clinical trial to assess the efficacy of a topical BRAF inhibitor for acneiform rash toxicities from anti-EGFR therapies

一项双盲、安慰剂对照的随机2期临床试验，以评估局部BRAF抑制剂对表皮生长因子受体（EGFR）拮抗剂治疗引起的痤疮样皮疹毒性的疗效。

Presenting Author:

报告作者：

Dr. Ofer Purim, Head of Gastrointestinal Malignancy Unit at the Helmsley Cancer Center, Shaare Zedek Medical Center,

奥弗·普里姆博士，赫尔姆斯利癌症中心（位于沙雷泽德克医疗中心）胃肠道恶性肿瘤科主任，

Jerusalem, Israel

以色列耶路撒冷

Abstract Number:

摘要编号：

Session Title:

会议标题：

Proffered Paper Session

提交论文会议

Session Date:

会话日期：

Friday July 4, 2025

2025年7月4日，星期五

Session Time:

会话时间：

5:30 –

5:40 pm CET

下午5点40分，欧洲中部时间

Session Location:

会话位置：

Madrid Room

马德里房间

About EGFR Inhibitor-Induced Rash

关于EGFR抑制剂引起的皮疹

EGFR is a receptor on the surface of cells which is expressed in many normal epithelial tissues, including skin. The EGFR signaling pathway is one of the key pathways that regulate growth, survival, proliferation, and differentiation of cells. B-Raf is a protein encoded by the BRAF gene and is a downstream effector component of the EGFR signaling pathway.

EGFR是细胞表面的一种受体，在许多正常的上皮组织中都有表达，包括皮肤。EGFR信号传导通路是调节细胞生长、存活、增殖和分化的主要通路之一。B-Raf是由BRAF基因编码的蛋白质，是EGFR信号传导通路的下游效应成分。

EGFR has been shown to be over-activated in various human cancers, including colorectal, lung, head and neck, urinary bladder, pancreatic and breast cancers, eliciting downstream phosphorylation and activation of the MAP Kinase pathway..

EGFR已被证明在多种人类癌症中过度激活，包括结直肠癌、肺癌、头颈癌、膀胱癌、胰腺癌和乳腺癌，引发下游MAP激酶通路的磷酸化和激活。

EGFR inhibitors can block the EGFR signal responsible for cell growth. Among the various types of pharmacological therapies for cancer, EGFR inhibitors are increasingly being used both as primary therapy as well as in patients who have progressed on prior chemotherapy treatments. Although effective as anti-cancer therapy leading to tumor shrinkage, EGFR inhibitors have many adverse reactions associated with their use.

EGFR抑制剂可以阻断负责细胞生长的EGFR信号。在癌症的各种药物治疗方法中，EGFR抑制剂正越来越多地被用作主要疗法，同时也用于先前化疗治疗后病情进展的患者。尽管作为抗癌治疗有效并能导致肿瘤缩小，但EGFR抑制剂的使用伴随着许多不良反应。

The majority of patients treated with EGFR inhibitors will experience adverse dermatological side effects typically manifested as a papulopustular skin rash, also known as acneiform lesions, which can impact quality of life and affect adherence to therapy..

大多数接受EGFR抑制剂治疗的患者会出现不良的皮肤反应，通常表现为丘疹脓疱性皮疹，也称为痤疮样病变，这可能会影响生活质量并影响对治疗的依从性。

About LUT014

关于LUT014

LUT014 is a novel B-Raf inhibitor which is applied topically to the skin. When the B-Raf protein is mutated, as is the case in some human cancers such as melanoma, blocking this pathway leads to apoptosis of the cells and tumor shrinkage. However, when the same pathway is blocked in normal, non-mutated cells, the opposite happens: the MAPK pathway is activated, and cells start growing.

LUT014是一种新型的B-Raf抑制剂，可外用涂抹于皮肤。当B-Raf蛋白发生突变时（如某些人类癌症，例如黑色素瘤），阻断该通路会导致细胞凋亡和肿瘤缩小。然而，在正常非突变细胞中阻断同一通路时，结果却相反：MAPK通路被激活，细胞开始生长。

This phenomenon is recognized as the paradoxical effect of B-Raf Inhibitors. LUT014 harnesses the paradoxical effect of B-Raf Inhibitors in order to enhance cell proliferation and balance cell destruction, typical to radiation dermatitis..

这种现象被认为是B-Raf抑制剂的矛盾效应。LUT014利用B-Raf抑制剂的矛盾效应，以促进细胞增殖并平衡细胞损伤，这是放射性皮炎的典型特征。

About Lutris Pharma

关于Lutris制药公司

Lutris Pharma is a clinical stage biopharmaceutical company focused on improving anti-cancer therapy effectiveness and quality of life for patients who are being treated with EGFR (Epidermal Growth Factor Receptor) inhibitors or with radiation, where dermal toxicity often leads to a reduction of anti-cancer therapy compliance.

Lutris Pharma是一家处于临床阶段的生物制药公司，专注于提高接受EGFR（表皮生长因子受体）抑制剂或放疗患者的抗癌治疗效果和生活质量，这些患者常因皮肤毒性而导致抗癌治疗依从性降低。

The company aims to provide novel topical therapies in order to mitigate these side effects. Lutris Pharma's lead asset, LUT014, a topical B-Raf Inhibitor, is a proprietary, first-in-class, small molecule, which has completed enrollment in a phase 2 clinical trial in metastatic colorectal cancer patients with EGFR inhibitor induced acneiform lesions and has successfully completed a phase 1/2 study for the treatment of radiation-induced dermatitis in breast cancer patients..

该公司旨在提供新颖的局部治疗方法，以减轻这些副作用。Lutris Pharma的核心资产LUT014是一种局部B-Raf抑制剂，属于专有、首创新药的小分子药物，目前已完成针对EGFR抑制剂诱发的痤疮样皮疹的转移性结直肠癌患者的二期临床试验入组，并已成功完成针对乳腺癌患者放射性皮炎治疗的一期/二期研究。

For more information, please visit

更多信息，请访问

www.lutris-pharma.com

。

Contacts:

联系人：

Lutris Pharma

Lutris制药

Sumant Ramchandra

苏曼特·拉姆钱德拉

, M.D., Ph.D.

，医学博士，哲学博士