• First patient dosed with topical RLS-1496 in clinical trial will assess the safety and clinical effects of single and multiple doses to treat adults with mild to moderate and stable plaque psoriasis, skin aging, and additional inflammatory diseases, including atopic dermatitis, vitiligo, rosacea, alopecia areata, and scleroderma1

• RLS-1496 – a first-in-class disease-altering GPX4 modulator selectively targeting pathological senescent cells that drive inflammaging and chronic degenerative diseases and conditions associated with the biological aging process2 – is the first GPX4 modulator to enter a human clinical trial, ahead of many leading biopharmaceutical companies evaluating the same target

• RLS-1496 uses Rubedo’s proprietary, AI-driven drug discovery platform ALEMBIC™, which identifies targets within pathologic senescent cells and develops selective cellular rejuvenation medicines for these targets

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, today announced that the first patient has been dosed with lead drug candidate RLS-1496 in the company’s single-center, ascending-dose, randomized, double-blind, vehicle-controlled trial. The study marks the first time a GPX4 (glutathione peroxidase) modulator has entered Phase 1 clinical trial and is designed to assess the safety, tolerability, clinical effects, plasma bioavailability, and pharmacodynamics of topical RLS-1496 in male or female patients 18 years or older with mild to moderate and stable plaque psoriasis. These subjects’ aging skin will also be treated and assessed to see if RLS-1496 can improve biomarkers of aging and reverse the skin age or biological clock. Based on the results of this study, the trial will potentially expand to additional inflammatory skin conditions and autoimmune disorders, including but not limited to atopic dermatitis, vitiligo, rosacea, alopecia areata, and scleroderma.3 A systemic formulation of RLS-1496 is planned to enter Phase 1 clinical trials in 2026.

“We are excited to reach this important milestone not only for our lead candidate RLS-1496 but also for the advancement of longevity science,” said Rubedo CEO Frederick Beddingfield, III, MD, PhD, FAAD, FACMS. “As the first company to treat patients with a GPX4 modulator targeting senescent cells in a data-rich Phase 1 clinical trial, we look forward to assessing its potential disease-altering effects on inflammatory skin conditions and skin aging, driving our pipeline forward in line with our goal of making a meaningful impact on age-related diseases and conditions, such as obesity and pain.”

Rubedo Chief Scientific Officer Marco Quarta, PhD, said, “For the last decade, longevity scientists have been working to develop a compound ready for human trials that safely and effectively targets pathologic senescent cells. We are proud that our team developed RLS-1496 into a topical drug candidate in less than three years from initiation – two times faster than the industry average1 via ALEMBIC™, our proprietary AI-driven drug discovery platform with SenTeCh™ chemistry technology. The other candidates in our pipeline are following similar expedited timelines, including systemic RLS-1496, which is aimed to begin Phase 1 clinical trials in 2026.”

About the RLS-1496 Phase 1 Clinical Trial

The design of the clinical trial is to assess primary and secondary objectives of safety and clinical effects of single and multiple doses of topical RLS-1496, compared to vehicle (control), in patients with mild to moderate stable plaque psoriasis. A key secondary objective is to evaluate the effects of RLS-1496 on target psoriasis lesions using a common measure of psoriasis severity, the modified Investigator’s Global Assessment (mIGA), to evaluate improvement. The trial will be conducted at a single center in The Netherlands with approximately 24 enrolled patients, starting with single dose application followed by a multidose protocol.

The design of the trial was developed with key insights provided by Rubedo’s Clinical Advisory Board (CAB), which is led by Rubedo Chief Medical Officer and dermatologist Mary Spellman, MD. The CAB includes the following leading dermatologists who are both practicing clinicians and researchers, and are supporting Rubedo as strategic and scientific consultants and advisors:

• Mark Lebwohl, MD, Professor & Chairman Emeritus of the Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York City, NY
• Ted Lain, MD, MBA, Executive Director & Principal Investigator, Austin Institute for Clinical Research; CMO, Sanova Dermatology, Austin, TX
• Zoe Draelos, MD, Founder, Dermatology Consulting Services, High Point, NC
• Chris Griffiths, OBE MD FRCP, Emeritus Professor of Dermatology, University of Manchester; Adjunct Professor of Dermatology, Kings College of London, London, England

Dr. Lebwohl said, “As clinicians, we are excited about the potential use of RLS-1496 as a topical treatment for psoriasis, other chronic inflammatory skin conditions, and skin aging itself. As researchers, we are intrigued by RLS-1496 as a potential first-in-class GPX4 modulator that was designed to selectively target inflammaging pathologic senescent cells and surrounding tissues. This is a very important milestone in longevity science, and we are thrilled to be working with the Rubedo team to drive this science forward.”

About RLS-1496 and GPX4 Modulation

Rubedo’s lead candidate RLS-1496 is a potential first-in-class, disease-altering GPX4 modulator selectively targeting pathologic senescent “zombie” cells that drive chronic degenerative diseases and conditions associated with biological aging processes. These include immunology and inflammation (I&I), dermatology and skin aging, metabolic syndrome (obesity, diabetes, liver fibrosis), sarcopenia, and neurodegenerative disease.

GPX4 is a major antioxidant-regulating enzyme that protects cells and tissues from free radical damage and is essential for cell survival. In contrast, GPX4 deficiency is associated with regulated cell death (RCD), especially ferroptosis. In certain pathologic cells, aging is associated with an imbalance in GPX4. By modulating GPX4 to selectively encourage cell death in ferroptosis-sensitive senescent zombie cells, RLS-1496 may be able to clear these cells to not only fight disease, but also support healthy cells to function properly.

About Rubedo Life Sciences

Rubedo Life Sciences is a clinical-stage biotech developing a broad portfolio of innovative selective cellular rejuvenation medicines targeting aging cells that drive chronic age-related diseases. Our proprietary AI-driven ALEMBIC™ drug discovery platform is developing novel first-in-class small molecules to selectively target pathologic and senescent cells, which play a key role in the progression of pulmonary, dermatological, oncological, neurodegenerative, fibrotic, and other chronic disorders. Our lead drug candidate – RLS-1496, a potential first-in-class disease-altering GPX4 modulator – is currently in Phase I clinical trials. The Rubedo leadership team is composed of industry leaders and early pioneers in chemistry, AI technology, longevity science, and life sciences, with expertise in drug development and commercialization from both large pharmaceutical and leading biotechnology companies. The company is headquartered in Sunnyvale, CA, USA, and has offices in Milan, Italy. For additional information, visit www.rubedolife.com.

References

1. https://matchtrial.health/en/how-long-does-it-take-to-develop-a-new-drug/
2. Quarta M, PhD, Co-founder and Chief Scientific Officer, Rubedo Life Sciences. Treatment of ex-vivo biopsies of human skin. Presented at: Advancing Innovation in Dermatology, Dermatology Summit 2025. January 12, San Francisco, CA.
3. Data on file, Rubedo Life Sciences, Sunnyvale, CA 94085.

Fonte: Business Wire