Rubedo Life Sciences received clearance from the U.S. Food and Drug Administration (FDA) to begin a Phase 1b/2a clinical trial for its drug candidate RLS-1496 to treat actinic keratosis. This is the second clinical trial for the drug, with the first already underway in Europe for conditions like psoriasis and atopic dermatitis. Both trials are expected to provide results in the fourth quarter of 2025.
RLS-1496 and Its Mechanism
RLS-1496 is a selective glutathione peroxidase 4 (GPX4) modulator. A modulator is a substance that regulates or adjusts the function of a particular biological system. In this case, RLS-1496 targets pathological senescent cells. These are also known as „zombie cells“ because they have stopped dividing but remain in the body and release pro-inflammatory signals. This chronic, low-grade inflammation associated with aging is called „inflammaging“.
Rubedo’s drug works by making these senescent cells vulnerable to ferroptosis, a form of programmed cell death. By clearing these cells, RLS-1496 aims to reduce inflammation and restore tissue function. The company’s ALEMBIC™ platform, which uses AI to identify these cellular targets and design small molecules, was instrumental in this discovery. RLS-1496 is being developed for both topical and oral use.
Clinical Development and Broader Context
Actinic keratosis is a common skin condition caused by sun damage that can progress into a type of skin cancer. By targeting this condition, Rubedo is addressing an age-related issue with a mechanism that could have broader implications. The company has also expanded its clinical advisory board with the addition of dermatologist and immunologist Emma Guttman-Yassky, further strengthening its expertise as it progresses through clinical trials.
The successful clearance for this new trial, in addition to the ongoing European study, shows the company’s ambition and the growing interest from regulatory bodies in treatments that specifically target the biological processes of aging.