LUT014 0.1% Gel Demonstrated Statistically Significant Improvement in Treatment Success Achieved by 71.8% of Patients Compared with 38.5% for Placebo (p=0.003)

LUT014 0.1%凝胶显示出统计学上显著的治疗成功率提升，71.8%的患者达到治疗成功，而安慰剂组为38.5%（p=0.003）

LUT014 0.1% Demonstrated Statistically Significant Improvement in Clinician-Assessed Rash Severity

LUT014 在临床医生评估的皮疹严重程度方面显示出具有统计学意义的显著改善

LUT014 0.1% Significantly Reduced Non-Adherence to EGFRI Therapy and Treatment Benefit Remained Durable Through Day 55

LUT014 使不依从 EGFR 抑制剂治疗的比例显著降低 0.1%，且治疗获益持续至第 55 天

TEL AVIV, Israel

以色列特拉维夫

,

，

Oct. 1, 2026

2026年10月1日

/PRNewswire/ --

/美通社/ --

Lutris Pharma

卢特里斯制药

,

，

a clinical stage biopharmaceutical company focused on improving the quality of life and drug adherence for patients treated with anti-cancer therapies by mitigating dermatological toxicities, today announced positive updated results from its Phase 2, randomized, double-blind, placebo-controlled clinical trial of its lead compound, LUT014.

一家处于临床阶段的生物制药公司，专注于通过减轻皮肤毒性来改善接受抗癌治疗患者的生活质量和用药依从性，该公司今日宣布其主导化合物LUT014在二期、随机、双盲、安慰剂对照临床试验中的最新积极结果。

LUT014 is a novel topical B-Raf inhibitor designed to reduce or prevent worsening of dermatological toxicities caused by anti-cancer drugs that target the MAPK pathway through paradoxical MAPK reactivation. The results will be presented in an oral presentation at the 35th European Academy of Dermatology and Venereology (EADV) Congress, being held September 30 through October 3 in Vienna, Austria..

LUT014 是一种新型外用 B-Raf 抑制剂，旨在减轻或预防因靶向 MAPK 通路的抗癌药物通过悖论性 MAPK 再激活而引起的皮肤毒性恶化。相关结果将在于 9 月 30 日至 10 月 3 日在奥地利维也纳举行的第 35 届欧洲皮肤病与性病学会（EADV）大会上以口头报告形式发布。

The updated data show that LUT014 0.1% gel demonstrated statistically significant improvements across key measures of EGFRI-induced acneiform rash. The composite primary endpoint of Treatment Success was achieved in 71.8% of patients receiving LUT014 0.1% gel compared with 38.5% receiving placebo (p=0.003).

更新后的数据显示，LUT014 0.1%凝胶在EGFRI诱导的痤疮样皮疹的关键指标上均显示出统计学意义上的显著改善。接受LUT014 0.1%凝胶治疗的患者中有71.8%达到了“治疗成功”这一复合主要终点，而接受安慰剂治疗的患者中这一比例为38.5%（p=0.003）。

Within the composite endpoint, evaluating the component of the clinician reported outcome measure CTCAE acneiform rash v5.0, 56.4% of patients receiving LUT014 0.1% achieved at least a one-grade improvement compared with 15.4% receiving placebo (p=0.0002) and, evaluating the component of the patient-reported outcome measure using the 13 skin-specific questions from FACT-EGFRI-18 questionnaire, 53.8% of patients receiving LUT014 0.1% achieved at least a five-grade improvement compared with 28.2% receiving placebo (p=0.021) The effect of LUT014 was durable on Day 55, with the composite primary endpoint of Treatment Success achieved in 69.2% of patients receiving LUT014 0.1% gel compared with 31.8% receiving placebo (p=0.005).

在复合终点中，评估临床医生报告结局指标（CTCAE 痤疮样皮疹 v5.0）的组成部分，接受 LUT014 0.1% 治疗的患者中有 56.4% 实现了至少一级的改善，而接受安慰剂治疗的患者中这一比例为 15.4%（p=0.0002）；在评估患者报告结局指标（采用 FACT-EGFRI-18 问卷中的 13 个皮肤特异性问题）的组成部分时，接受 LUT014 0.1% 治疗的患者中有 53.8% 实现了至少五分的改善，而接受安慰剂治疗的患者中这一比例为 28.2%（p=0.021）。LUT014 的疗效在第 55 天持续存在，接受 LUT014 0.1% 凝胶治疗的患者中有 69.2% 达到了“治疗成功”这一复合主要终点，而接受安慰剂治疗的患者中这一比例为 31.8%（p=0.005）。

Importantly, non-adherence to the EGFRI therapy occurred in only 10.3% of patients receiving LUT014 0.1% compared with 28.2% receiving placebo (p=0.044), supporting continued EGFRI therapy at prescribed dosing. The safety profile of LUT014 remains favorable, as previously presented..

重要的是，在接受0.1% LUT014治疗的患者中，仅有10.3%未依从EGFRI治疗，而安慰剂组为28.2%（p=0.044），这支持按处方剂量继续EGFRI治疗。LUT014的安全性特征依然良好，如前所述。

'Acneiform rash related to EGFR inhibitor therapy is associated with significant symptoms and reduced quality of life for patients. This can contribute to dose delays, reductions and discontinuation of anti-cancer treatment,' said Anisha Patel, MD, professor of dermatology at The University of Texas MD Anderson Cancer Center.

“与EGFR抑制剂治疗相关的痤疮样皮疹会导致患者出现显著症状并降低其生活质量。这可能导致抗癌治疗的剂量延迟、减量或停药，”德克萨斯大学MD安德森癌症中心皮肤科教授、医学博士Anisha Patel表示。

'These results demonstrate that LUT014 may produce meaningful improvements in EGFRI-induced acneiform rash while supporting patients' ability to remain on their prescribed anti-cancer therapy. Particularly encouraging is the durability of the observed benefit beyond the 28-day treatment period and the activity seen even in the presence of baseline antibiotic use.

这些结果表明，LUT014 可能在改善 EGFR 抑制剂诱导的痤疮样皮疹方面产生具有临床意义的疗效，同时支持患者继续使用其处方的抗癌治疗。尤其令人鼓舞的是，观察到的获益在 28 天治疗期结束后仍具有持久性，即使在基线期使用抗生素的情况下也显示出活性。

LUT014's mechanism-directed approach is designed to reverse the suppressed MAP kinase signaling that initiates this toxicity rather than block the EGFRI drug binding or only targeting the downstream inflammatory response.'.

LUT014 采用机制导向的方法，旨在逆转引发该毒性的受抑制 MAP 激酶信号通路，而非阻断 EGFR 抑制剂的药物结合或仅针对下游炎症反应。

'We are encouraged by the positive results of our Phase 2 clinical trial in EGFRI-induced acneiform rash in terms of efficacy, safety and tolerability of LUT014,' stated Professor Antoni Ribas, M.D., Ph.D., Founder and Board Member of Lutris Pharma. 'On the strength of these data, Lutris plans to initiate a Phase 2 study of LUT014 0.1% Gel in daraxonrasib-induced acneiform rash in patients with pancreatic ductal adenocarcinoma.

“LUT014在EGFR抑制剂诱导的痤疮样皮疹的II期临床试验中，在疗效、安全性和耐受性方面取得的积极成果令我们备受鼓舞。”Lutris Pharma创始人兼董事会成员Antoni Ribas医学博士、哲学博士表示。“基于这些数据，Lutris计划启动一项关于LUT014 0.1%凝胶治疗胰腺导管腺癌患者中daraxonrasib诱导的痤疮样皮疹的II期研究。”

Because LUT014 is a mechanistic drug that reverses the suppressed MAPK signaling, it has the potential to treat acneiform rash induced by other MAPK-pathway inhibitors. Lutris is exploring opportunities to study LUT014 with other MAPK-pathway inhibitors through partnerships and independently.'.

由于LUT014是一种能够逆转被抑制的MAPK信号通路的机制性药物，因此它具有治疗由其他MAPK通路抑制剂引起的痤疮样皮疹的潜力。Lutris正在通过合作伙伴关系以及独立开展的方式，探索研究LUT014与其他MAPK通路抑制剂联合应用的机会。

LUT014 completed a Phase 2 double-blind, placebo-controlled, randomized, multisite study to evaluate the efficacy and safety of two strengths of LUT014 Gel topically applied once a day for 28 days in colorectal cancer (CRC) patients who developed CTCAE Grade 2 or non-infected Grade 3 EGFRI-induced acneiform lesions after receiving cetuximab or panitumumab (NCT04759664).

LUT014 完成了一项二期、双盲、安慰剂对照、随机、多中心研究，旨在评估每日一次局部外用两种浓度的 LUT014 凝胶、连续使用 28 天，在接受西妥昔单抗或帕尼单抗治疗后出现 CTCAE 2 级或非感染性 3 级 EGFRI 诱导的痤疮样皮疹的结直肠癌（CRC）患者中的疗效和安全性（NCT04759664）。

The trial enrolled 118 adult CRC patients who received LUT014 0.1% gel (n=39), LUT014 0.03% gel (n=40), or placebo gel (n=39), applied once daily for 28 days, followed by a 28-day observation period. The composite primary endpoint, Treatment Success, was assessed at Day 28 and required at least a one-grade improvement in CTCAE v5.0 acneiform rash or at least a five-point improvement in patient symptoms as measured by the first 13 questions of the skin-specific FACT-EGFRI-18 score, together with the absence of Treatment Failure.

该试验入组了118例成年结直肠癌（CRC）患者，分别接受LUT014 0.1%凝胶（n=39）、LUT014 0.03%凝胶（n=40）或安慰剂凝胶（n=39）治疗，每日一次，连续使用28天，随后进行28天的观察期。复合主要终点“治疗成功”在第28天进行评估，要求CTCAE v5.0痤疮样皮疹至少改善1级，或皮肤特异性FACT-EGFRI-18量表前13个问题所评估的患者症状至少改善5分，同时未出现“治疗失败”。

Treatment Failure included EGFRI dose reduction, delay or discontinuation due to rash; initiation or escalation of antibiotics for rash; or study-drug discontinuation due to worsening rash..

治疗失败包括因皮疹导致的EGFR抑制剂剂量减少、延迟给药或停药；因皮疹而开始使用或升级抗生素治疗；或因皮疹恶化而停用研究药物。

Presentation Details:

演示详情：

Presentation Title:

演示标题：

Acneiform Rash from EGFR Inhibitor Therapy: Durable, Mechanism-Directed Reduction with Topical LUT014 (B-RAF Inhibitor) in a Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial

EGFR抑制剂治疗引起的痤疮样皮疹：在一项2期、随机、双盲、安慰剂对照试验中，外用LUT014（B-RAF抑制剂）实现持久且针对机制的缓解

Presenting Author:

报告作者：

Anisha Patel, MD, Professor, Department of Dermatology, The University of Texas MD Anderson Cancer Center, Houston, TX

安妮莎·帕特尔，医学博士，教授，德克萨斯大学安德森癌症中心皮肤科，休斯顿，德克萨斯州

Abstract ID:

摘要编号：

AS-1328

AS-1328

Session Title:

会话标题：

Free Communication 6: Pruritus/Adverse Drug Reactions

自由交流6：瘙痒/药物不良反应

Session Date:

会话日期：

Friday, October 2, 2026

2026年10月2日，星期五

Presentation Time:

演示时间：

11:25 – 11:35 am CET

中欧时间上午 11:25 – 11:35

Session Location:

会话位置：

Hall N

N厅

The presentation materials will be available on the

演示材料将在

Lutris website

Lutris 网站

after the presentation.

在演示之后。

About MAPK inhibitor-Induced Rash

关于MAPK抑制剂引起的皮疹

Inhibitors of the MAP Kinase (MAPK) pathway are a class of drugs used to treat certain cancers. EGFR inhibitors are among the targeted therapies that inhibit MAPK pathway signaling. EGFR is a receptor on the surface of cells which is expressed in many normal epithelial tissues, including skin and the EGFR signaling pathway is critical in regulating growth, survival, proliferation, and differentiation of cells.

MAP激酶（MAPK）通路抑制剂是一类用于治疗某些癌症的药物。EGFR抑制剂是抑制MAPK通路信号的靶向疗法之一。EGFR是细胞表面的一种受体，在许多正常上皮组织（包括皮肤）中表达，EGFR信号通路在调节细胞的生长、存活、增殖和分化方面起着关键作用。

B-Raf is a protein that is a key regulator of the MAPK pathway. Oncogenic EGFR constitutively signals through the MAPK pathway, leading to uncontrolled cell proliferation in various human cancers, including colorectal, lung, head and neck, urinary bladder, pancreatic and breast cancers..

B-Raf 是一种蛋白质，是 MAPK 通路的关键调节因子。致癌性 EGFR 通过 MAPK 通路持续发出信号，导致包括结直肠癌、肺癌、头颈癌、膀胱癌、胰腺癌和乳腺癌在内的多种人类癌症中出现不受控制的细胞增殖。

EGFR inhibitors can block the EGFR signal responsible for cell growth and 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 lead to many adverse reactions, with the majority of patients experiencing 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..

EGFR抑制剂能够阻断负责细胞生长的EGFR信号，正日益被用作一线治疗，以及用于既往化疗治疗后病情进展的患者。尽管EGFR抑制剂作为抗癌疗法能有效缩小肿瘤，但也会引发许多不良反应，其中大多数患者会出现皮肤副作用，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降低治疗依从性。

About LUT014

关于 LUT014

LUT014 is a proprietary, first-in-class, novel small molecule, topical B-Raf inhibitor designed to reduce or prevent worsening of dermatological toxicities caused by anti-cancer drugs that target the MAPK pathway through paradoxical MAPK reactivation. LUT014 is formulated as a gel and designed to be applied to the affected areas of the skin.

LUT014 是一种专有、首创新类的小分子外用 B-Raf 抑制剂，旨在通过缓解因靶向 MAPK 通路的抗癌药物引起的反常性 MAPK 再激活所导致的皮肤毒性恶化或预防其发生。LUT014 配制为凝胶剂型，设计用于涂抹于受影响的皮肤区域。

When a MAPK inhibitor that acts upstream of B-Raf is used for cancer treatment (e.g., EGFR inhibitors and RAS inhibitors), the MAPK pathway reduces or stops signaling. This causes cell death in both the cancer cells and normal cells. While the death of cancer cells is the desired effect, the death of non-cancer cells, such as those of the skin, is not desired and leads to side effects such as acneiform rash.

当用于癌症治疗的MAPK抑制剂作用于B-Raf上游时（例如EGFR抑制剂和RAS抑制剂），MAPK信号通路的信号传导会减弱或停止。这会导致癌细胞和正常细胞均发生死亡。虽然癌细胞死亡是期望的治疗效果，但非癌细胞（如皮肤细胞）的死亡并非所愿，并会导致诸如痤疮样皮疹等副作用。

In cells where the MAPK is inhibited, when the B-Raf protein is also inhibited, the MAPK signaling becomes reactivated. This phenomenon is recognized as the paradoxical effect of B-Raf Inhibitors. LUT014 gel harnesses this paradoxical effect to rescue the skin cells. Due to its overwhelmingly local penetration, LUT014's activity is restricted to the skin.

在MAPK被抑制的细胞中，当B-Raf蛋白也被抑制时，MAPK信号通路会重新激活。这一现象被称为B-Raf抑制剂的悖论效应。LUT014凝胶利用这种悖论效应来修复皮肤细胞。由于其极强的局部渗透性，LUT014的活性局限于皮肤。

To date, LUT014 has shown favorable safety and clinical benefit in a completed a Phase 2 clinical trial in metastatic colorectal cancer patients with EGFR inhibitor-induced acneiform lesions..

迄今为止，LUT014 在一项针对伴有 EGFR 抑制剂诱导的痤疮样皮损的转移性结直肠癌患者中完成的 II 期临床试验中，显示出良好的安全性和临床获益。

About Lutris Pharma

关于Lutris Pharma

Lutris Pharma is a privately owned clinical-stage biopharmaceutical company with a mission to improve the quality of life and drug adherence for patients who are being treated with certain anti-cancer drugs. Lutris Pharma's key asset is LUT014, a proprietary, first-in-class, small molecule, topical B-Raf inhibitor formulated as a gel and designed to be applied to affected areas of the skin in patients treated with certain MAPK inhibitors, such as EGFR inhibitors or RAS inhibitors, which causes most patients to experience dermatological toxicities..

Lutris Pharma 是一家私有临床阶段生物制药公司，其使命是提高接受某些抗癌药物治疗患者的生活质量和用药依从性。Lutris Pharma 的核心资产是 LUT014，这是一种专有、首创的小分子外用 B-Raf 抑制剂，制成凝胶剂型，旨在用于接受某些 MAPK 抑制剂（如 EGFR 抑制剂或 RAS 抑制剂）治疗的患者皮肤患处，因为这些药物会导致大多数患者出现皮肤毒性反应。

For more information, please visit

欲了解更多信息，请访问

www.lutris-pharma.com

www.lutris-pharma.com

.

。

Contacts:

联系人：

Rx Communications Group

Rx通信集团

Michael Miller

迈克尔·米勒

+1-917-633-6086

+1-917-633-6086

[email protected]

[email protected]

SOURCE Lutris Pharma

来源：Lutris Pharma

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