SAN FRANCISCO -- Rubedo Life Sciences, Inc. (Rubedo), an AI-driven, clinical-stage biotech focused on discovering and rapidly developing selective cellular rejuvenation medicines targeting aging cells, announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for a Phase 1b/2a study with lead drug candidate RLS-1496 in patients with actinic keratosis. RLS-1496 is a first-in-class disease-modifying selective glutathione peroxidase 4 (GPX4) modulator targeting pathological senescent cells that drive inflammaging and chronic degenerative diseases and conditions associated with the biological aging process. The study is expected to begin in Q4 2025. The first EMA-cleared RLS-1496 clinical trial began in May 2025 for plaque psoriasis, atopic dermatitis, and skin aging (photoaged skin); study results are expected in Q4 2025.

Actinic keratosis is a rough, scaly patch caused by sun exposure that appears on sun-exposed areas of the skin, such as the face, scalp, and hands. Left untreated, it may become cancerous. It is a common condition, affecting approximately 20% of people in the United States, and 14% of people globally.[1,2] Actinic keratosis is one of several senescence-driven and GPX4-moderated inflammatory skin conditions identified by Rubedo’s proprietary, AI-driven drug discovery platform, ALEMBIC™, and shown in the company’s ex vivo studies of human tissue. ALEMBIC identifies cellular and molecular targets for pathologic senescent cells and develops selective medicines that restore tissue homeostasis for these targets. 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.[3,4] About 7.3% of U.S. adults have atopic dermatitis, while globally the prevalence among adults is approximately 2.0%.[5,6]

“We are thrilled to reach another important milestone with our lead candidate RLS-1496,” said Rubedo CEO Frederick Beddingfield, III, MD, PhD, FAAD, FACMS. “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, which will allow us to have the greatest impact for patients.”

Rubedo Chief Scientific Officer Marco Quarta, PhD, said, “This IND clearance comes just four months after the initiation of a Phase 1 study with RLS-1496 in patients with psoriasis in Europe. We are excited to begin this new trial and showcase the breadth of therapeutic impact that can be made by targeting inflammatory and aging mechanisms like GPX4.”

Rubedo has also welcomed a new member to its Clinical Advisory Board (CAB), Emma Guttman-Yassky, MD, PhD, Waldman Professor and Chair of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai. She is the Director of the Occupational Dermatitis Clinic and Director of the Laboratory for Inflammatory Skin Diseases.

With the addition of Dr. Guttman, the CAB - led by Rubedo Chief Medical Officer and dermatologist Mary Spellman, MD - now includes five leading dermatologists who are practicing clinicians and researchers, and are supporting Rubedo as strategic and scientific consultants and advisors.

Dr. Guttman said, “Millions of people are affected by dermatologic inflammatory skin conditions, including psoriasis and actinic keratosis. As a researcher and clinician, I am inspired by cutting-edge longevity science and recognize the need for new innovations that can improve patient health. This IND clearance is an important step forward in making these types of innovations a reality, and I am delighted to be working with the Rubedo team at this exciting time.”