SAN FRANCISCO– Rubedo Life Sciences, Inc., an AI-driven, clinical-stage biotech developing selective cellular rejuvenation medicines, announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug (IND) application for a Phase 1b/2a study of RLS-1496 in patients with actinic keratosis. The study is expected to begin in the fourth quarter of 2025.
RLS-1496 is a first-in-class selective glutathione peroxidase 4 (GPX4) modulator that targets pathological senescent cells driving chronic inflammation and degenerative diseases associated with aging. It is the second clinical study accepted for RLS-1496, following a European trial that began in May 2025 in patients with psoriasis, atopic dermatitis, and skin aging. Results from that study are anticipated later this year.
Actinic keratosis, caused by prolonged sun exposure, is a common precancerous skin condition that affects about 20 percent of people in the United States and 14 percent worldwide. Left untreated, it can progress to skin cancer. Current treatments are limited, and Rubedo believes RLS-1496 can address a significant unmet medical need by clearing senescent “zombie” cells through GPX4 modulation and ferroptosis, a programmed form of cell death.
“We are thrilled to reach another important milestone with our lead candidate RLS-1496,” said Frederick Beddingfield, III, M.D., Ph.D., Chief Executive Officer of Rubedo Life Sciences. “This second IND clearance supports our focus on the potential of RLS-1496 as the first-ever GPX4 modulator to treat an array of age-related diseases and conditions, allowing us to have the greatest impact for patients.”
Rubedo Chief Scientific Officer Marco Quarta, Ph.D., added, “This IND clearance comes just four months after the initiation of our first clinical study with RLS-1496 in Europe. We are excited to begin this new trial and further demonstrate the breadth of therapeutic potential that can be achieved by targeting inflammatory and aging mechanisms through GPX4.”
The company also announced the expansion of its Clinical Advisory Board with the addition of Emma Guttman-Yassky, M.D., Ph.D., Waldman Professor of Dermatology and Immunology and Health System Chair of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai. Dr. Guttman is internationally recognized for her work in inflammatory skin diseases and will join Rubedo’s advisory board, led by Chief Medical Officer Mary Spellman, M.D., alongside four other leading dermatologists.
“Millions of people are affected by dermatologic inflammatory skin conditions, including psoriasis and actinic keratosis,” said Dr. Guttman. “This IND clearance is an important step forward in making new innovations possible, and I am delighted to be working with the Rubedo team at such an exciting time.”
RLS-1496 is being developed in both topical and oral formulations to target a wide range of chronic conditions linked to senescent cells, including immunologic and inflammatory diseases, dermatology and skin aging, metabolic syndrome, sarcopenia, and neurodegenerative disorders.
