Lutris Pharma Announces Positive Updated Phase 2 Data Demonstrating Durable, Mechanism-Directed Benefit of LUT014 Gel for EGFRI-Induced Acneiform Rash at the EADV Congress

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% Demonstrated Statistically Significant Improvement in Clinician-Assessed Rash Severity

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

TEL AVIV, Israel, Oct. 1, 2026 /PRNewswire/ -- Lutris Pharma, 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. 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.

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). 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). 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.

"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. "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. 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."

"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. 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."

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). 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. 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.

Presentation Details:

• Presentation Title: 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
• Presenting Author: Anisha Patel, MD, Professor, Department of Dermatology, The University of Texas MD Anderson Cancer Center, Houston, TX
• Abstract ID: AS-1328
• Session Title: Free Communication 6: Pruritus/Adverse Drug Reactions
• Session Date: Friday, October 2, 2026
• Presentation Time: 11:25 – 11:35 am CET
• Session Location: Hall N

The presentation materials will be available on the Lutris website after the presentation.

About MAPK inhibitor-Induced Rash
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. 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.

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.

About 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. 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. 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. 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.

About 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.

For more information, please visit www.lutris-pharma.com.

Contacts:

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Michael Miller
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SOURCE Lutris Pharma