September 17, 2025 — Leads & Copy — Rubedo Life Sciences, Inc. has received FDA clearance for its Investigational New Drug (IND) application for a Phase 1b/2a study of RLS-1496 in patients with actinic keratosis. RLS-1496 is a selective glutathione peroxidase 4 (GPX4) modulator that targets pathological senescent cells.
The study is expected to begin in Q4 2025. An EMA-cleared clinical trial for RLS-1496 began in May 2025 for plaque psoriasis, atopic dermatitis, and skin aging, with results expected in Q4 2025.
Actinic keratosis affects approximately 20% of people in the United States and 14% globally. Rubedo’s AI-driven drug discovery platform, ALEMBIC™, identified Actinic keratosis as one of several senescence-driven and GPX4-moderated inflammatory skin conditions. RLS-1496 is also being studied in psoriasis and atopic dermatitis. Approximately 3% of adults in the United States, and 4.4% of adults globally, have psoriasis. About 7.3% of U.S. adults have atopic dermatitis, while globally the prevalence among adults is approximately 2.0%.
Rubedo CEO Frederick Beddingfield, III, MD, PhD, FAAD, FACMS, said the IND clearance supports the potential of RLS-1496 as the first GPX4 modulator to treat age-related diseases. Rubedo Chief Scientific Officer Marco Quarta, PhD, noted the clearance follows the initiation of a Phase 1 study with RLS-1496 in Europe for psoriasis patients.
Rubedo has also welcomed Emma Guttman-Yassky, MD, PhD, to its Clinical Advisory Board (CAB).
Dr. Guttman said the IND clearance is an important step forward in making innovations a reality.
RLS-1496 is being developed for topical and oral administration and targets pathologic senescent cells that drive chronic degenerative diseases and conditions associated with biological aging processes.
Contact:
Mary Spellman, MD – Rubedo Chief Medical Officer
