TEL AVIV, Israel, October 24, 2022 /PRNewswire/ — Lutris Pharma, a clinical-stage biopharmaceutical company focused on improving cancer therapies by reducing dose-limiting side effects, today announced that the California Institute of Regenerative Medicine (CIRM) has awarded the founder and chairman of the company’s board of directors, Antoine RibasMD, 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 BRAF inhibitor, for skin regeneration and wound healing.
The award will support the completion of Enabling Investigational New Drug (IND) studies. Specifically, the funds will be used for the manufacturing of the active pharmaceutical ingredient (API) LUT017 and the final formulated pharmaceutical product (GEL LUT017) to deliver the proposed studies; evaluation of the stability, efficacy and tolerability of study drugs in preclinical models; and the completion of IND’s submission to the United States Food and Drug Administration (FDA) for a Phase 1 clinical trial in patients with venous leg ulcers, with Dr. Ribas as the principal investigator.
“Non-healing skin ulcers affect 1 in 100 Californians and there are currently no FDA-approved drug treatments available,” Dr. Ribas said. “This condition has a disproportionate effect on underserved populations and is common in people with diabetes, obesity, and limited movement. Topical use of a BRAF inhibitor has been shown to regenerate stem cells from the skin in preclinical models, thereby accelerating wound closure and with these studies we aim to show that administration of LUT017 gel will regenerate skin stem cells and induce keratinocyte proliferation resulting in improvement of venous ulcer wounds non-healing legs.
Noa Shelach, Ph.D., President and CEO of Lutris Pharma, said, “The ability to complete this important preclinical work, made possible by grant funding from CIRM, signals the expansion of our new portfolio of products for non-oncological indications. The successful development of this program will enable the use of this highly innovative treatment option for people with painful venous leg ulcers, which lead to loss of function and mobility, social isolation and increased time spent in hospitals. .
LUT017 is a new B-Raf inhibitor applied topically to the skin. Blocking the B-Raf pathway in B-Raf mutated cancer cells causes the tumor to shrink, but when the same pathway is blocked in normal, unmutated cells, the reverse happens: and the cells begin to grow . This phenomenon is recognized as the paradoxical effect of B-Raf inhibitors. LUT017 exploits this paradoxical effect to accelerate wound healing. In preclinical model studies of skin wounds, topical B-Raf inhibitor has been shown to stimulate the growth of skin stem cells to regenerate damaged tissue, thereby accelerating wound healing.
About Lutris Pharma
Lutris Pharma is a clinical-stage biopharmaceutical company focused on improving the efficacy of cancer therapies and the quality of life of patients treated with EGFR (epidermal growth factor receptor) inhibitors or radiation, where skin toxicity often results in reduced anti-cancer treatment compliance. The company aims to provide novel topical therapies to alleviate these side effects. Lutris Pharma’s lead asset, LUT014, a topical B-Raf inhibitor, is a first-in-class, proprietary small molecule currently in a Phase 2 clinical trial in metastatic colorectal cancer patients with acneiform lesions Inhibitor-Induced and Phase 1/2 Study for the Treatment of Radiation-Induced Dermatitis in Breast Cancer Patients. For more information, please visit www.lutris-pharma.com.
Noa Shelach, Ph.D.
Chief executive officer
Rx Communications Group
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