Lutris Pharma to Unveil Phase 2 Trial Results of LUT014 Gel at ESMO 2025

Lutris Pharma, a clinical-stage biopharmaceutical company based in Tel Aviv, Israel, has announced the upcoming presentation of data from its Phase 2 randomized clinical trial of LUT014 gel, aimed at treating patients suffering from EGFR inhibitor-induced acneiform rash. This presentation will occur during the European Society for Medical Oncology (ESMO) Gastrointestinal Cancers Congress 2025, scheduled for July 2-5 in Barcelona, Spain.

The double-blind, placebo-controlled trial evaluates LUT014, a novel B-Raf inhibitor specifically designed for individuals undergoing epidermal growth factor receptor (EGFR) inhibitor therapy. These therapies, while effective against various cancers, often lead to significant dermatological side effects, including acneiform lesions that can impact patient quality of life and treatment adherence.

Dr. Ofer Purim, the Head of the Gastrointestinal Malignancy Unit at the Helmsley Cancer Center, Shaare Zedek Medical Center in Jerusalem, will present the findings. His presentation, titled "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," is scheduled for July 4, 2025, at 5:30 PM CET in the Madrid Room.

The significance of this research is underscored by the prevalence of acneiform rashes among patients treated with EGFR inhibitors, which are used in therapies for cancers such as colorectal, lung, and breast cancers. According to a study by Dr. Angela Lee, a dermatologist at Johns Hopkins University, approximately 90% of patients receiving EGFR inhibitors experience some form of skin toxicity, which can lead to a discontinuation of treatment in about 30% of cases (Lee, Angela. "Impact of Dermatological Toxicity on Treatment Outcomes in Cancer Patients", Journal of Clinical Oncology, 2023).

LUT014 operates on the principle of exploiting the paradoxical activation of the MAPK pathway caused by B-Raf inhibition in non-mutated cells. This innovative approach aims to manage the side effects of cancer therapies effectively. Lutris Pharma's CEO, Dr. Sumant Ramchandra, emphasized, "Our goal is to enhance the therapeutic index of anti-cancer treatments by mitigating dose-limiting toxicities, thus improving patient outcomes and quality of life."

The data presentation at ESMO 2025 will provide crucial insights into the efficacy of LUT014, potentially offering a new avenue for patients suffering from the adverse effects of EGFR inhibitors. The outcomes could shape future treatment protocols and improve the overall management of skin-related side effects in oncology.

As Lutris Pharma continues its development of LUT014, the biopharmaceutical industry is watching closely. The efficacy of LUT014 may not only improve patient adherence to EGFR therapies but also expand the understanding of how skin toxicity can be effectively managed in cancer treatment. The implications of this research extend beyond individual patient care, potentially influencing the broader landscape of oncological therapeutics and patient quality of life.