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

TEL AVIV, Israel, June 17, 2025 /PRNewswire/ -- Lutris Pharma, 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. 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 July 2-5 in Barcelona, Spain.

Presentation Details:

• Presentation Title: 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
• Presenting Author: Dr. Ofer Purim, Head of Gastrointestinal Malignancy Unit at the Helmsley Cancer Center, Shaare Zedek Medical Center, Jerusalem, Israel
• Abstract Number: 50
• Session Title: Proffered Paper Session
• Session Date:Friday July 4, 2025
• Session Time: 5:30 - 5:40 pm CET
• Session Location: Madrid Room

About EGFR Inhibitor-Induced Rash
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 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 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. 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.

About 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. 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.

About Lutris Pharma
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. 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.

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

Contacts:

Lutris Pharma
Sumant Ramchandra, M.D., Ph.D.
Chief Executive Officer
[e-mail]

Noa Shelach, Ph.D.
Chief Operating Officer
[e-mail]

Rx Communications Group
Michael Miller
[phone]
[e-mail]

Logo - https://mma.prnewswire.com/media/1586358/5371989/Lutris_Logo.jpg

View original content:https://www.prnewswire.co.uk/news-releases/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-2025-302482579.html