LUT-017

TEL AVIV, Israel, Oct. 24, 2022 /PRNewswire/ -- Lutris Pharma, a clinical stage biopharmaceutical company focused on improving anti-cancer therapies by reducing dose limiting side effects, today announced that the California Institute of Regenerative Medicine (CIRM) has awarded company Founder and Chairman of the Board, Antoni Ribas, M.D., Ph.D., Professor of Medicine, Professor of Surgery, and Professor of Molecular and Medical Pharmacology at the University of California Los Angeles (UCLA), a $5.0 million grant to be used for the further development of Lutris Pharma's LUT017 gel, a novel, small molecule inhibitor of BRAF, for skin regeneration and wound healing. The award will allow for the completion of Investigational New Drug (IND)-enabling studies. Specifically, the funds will be utilized for the manufacturing of LUT017 active pharmaceutical ingredient (API) and the final formulated drug product (LUT017 gel) to supply the proposed studies; evaluation of study drug stability, efficacy and tolerability in preclinical models; and completion of the IND submission to the U.S. Food and Drug Administration (FDA) for a phase 1 clinical trial in patients with venous leg ulcers, with Dr. Ribas as principal investigator. "Non-healing skin ulcers affect 1 in every 100 Californians and there is presently no FDA-approved drug treatment," stated Dr. Ribas. "This condition has a disproportionate effect on underserved populations and is common among people with diabetes, obesity and limited movement. Topical use of a BRAF inhibitor has been shown to regenerate skin stem cells in preclinical models, thereby accelerating wound closure and, with these studies, we aim to show that administration of LUT017 gel will regenerate cutaneous stem cells and induce keratinocyte proliferation, resulting in an improvement of venous leg ulcer non-healing wounds." Noa Shelach, Ph.D., Chief Executive Officer of Lutris Pharma, noted, "The ability to complete this important, preclinical work, made possible by the grant funding from CIRM, signals the expansion of our novel product pipeline to non-oncological indications. Successful development of this program will enable use of this highly novel therapeutic option to those suffering from painful venous leg ulcers, which cause loss of function and mobility, social isolation and leads to increased time spent in hospitals." About LUT017 LUT017 is a novel B-Raf inhibitor which is applied topically on the skin. Blocking the B-Raf pathway in B-Raf mutated cancer cells leads to tumor shrinkage, but when the same pathway is blocked in normal, non-mutated cells, the opposite happens: and the cells start growing. This phenomenon is recognized as the paradoxical effect of B-Raf Inhibitors. LUT017 harnesses this paradoxical effect in order to accelerate wound healing. In preclinical model studies of skin wounds, the topical B-Raf inhibitor was found to stimulate the growth of skin stem cells to regenerate damaged tissue, thus accelerating wound healing. 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 currently in a phase 2 clinical trial in metastatic colorectal cancer patients with EGFR inhibitor induced acneiform lesions and a phase 1/2 study for the treatment of radiation-induced dermatitis in breast cancer patients. For more information, please visit . Contacts: Lutris Pharma Noa Shelach, Ph.D. Chief Executive Officer ir@lutris-pharma.com Rx Communications Group Michael Miller +1-917-633-6086 mmiller@rxir.com