Grant Funds Regenerative Gel for Treating Skin Ulcers

Antoni Ribas (University of California in Los Angeles)

24 Oct. 2022. A California state research agency is funding preclinical development of a gel designed to regenerate stem cells in the skin to help heal venous skin ulcers. The California Institute of Regenerative Medicine or CIRM is awarding $5 million to Antoni Ribas, professor of pharmacology at University of California in Los Angeles, for advancing the gel therapy to request approval from the Food and Drug Administration to begin a clinical trial.

Ribas and colleagues at UCLA study immunotherapies for melanoma, an aggressive skin cancer, as well as how resistance and adverse effects from immunotherapies form in patients. Research in the Ribas lab led to development of a topical gel that limits activity of the BRAF gene, where mutations in this gene cause disruptions in the normal cell activity, including movement and normal cell death. The lab also discovered this same property in the gel that inhibits mutated BRAF genes also regenerates stem cells in the skin that can help heal skin ulcers from malfunctioning veins, most often in the legs. These venous skin ulcers are open wounds that heal slowly, if at all.

Ribas is founder and board chair of the start-up company Lutris Pharma in Tel Aviv, Israel commercializing research from the UCLA lab limiting adverse effects of cancer treatments. The company’s technology seeks to reduce skin toxicity and rashes from treatments that limit expression of Epidermal Growth Factor Receptor or EGFR and BRAF genes, allowing for patients to continue with their cancer treatments, with their lead product in clinical trials among cancer patients.

“A disproportionate effect on underserved populations”

Another of Lutris Pharma’s products in development, code-named LUT017, applies a similar mechanism limiting BRAF proteins to venous skin ulcers. LUT017, says Lutris, regenerates stem cells in the skin to induce proliferation of keratinocytes, the most common type of skin cell, to promote closure of the normally slow-healing wounds. “Non-healing skin ulcers affect one in every 100 Californians and there is presently no FDA-approved drug treatment,” says Ribas in a company statement released through Cision. “This condition has a disproportionate effect on underserved populations and is common among people with diabetes, obesity, and limited movement.”

The CIRM award of just over $5 million is expected to fund final preclinical research, including treatment dose production of LUT017, to file an Investigational New Drug or IND application. An IND application is officially a request with FDA to transport an experimental drug across state lines, but an approved IND request is, in effect, clearance to begin a clinical trial.

“Topical use of a BRAF inhibitor has been shown to regenerate skin stem cells in preclinical models,” notes Ribas, “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.”

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