CAGE Bio, Inc., a clinical-stage biotechnology company focused on developing innovative therapies for immuno-dermatological disorders, has announced the initiation of a Phase 2b dose-ranging clinical trial for its topical JAK inhibitor, CGB-500. The trial is set to explore the efficacy and safety of the product in treating moderate to severe atopic dermatitis (AD), particularly in patients with low body surface area (BSA) involvement.
CGB-500, a groundbreaking ointment developed using CAGE Bio’s proprietary ionic liquid technology, is designed to target affected skin directly, providing high efficacy with minimal systemic exposure. In earlier clinical trials, CGB-500 demonstrated promising results. A Phase 2a trial conducted in 2024 showed that the treatment achieved an 8-week success rate of 95%, with a significant improvement in patients’ symptoms, including an Investigator Global Assessment (IGA) score of “0” or “1” and a greater than two-grade improvement.
The upcoming Phase 2b trial, which will enroll 180 participants, aims to refine dosing regimens and further assess the safety and effectiveness of CGB-500. This pivotal study is expected to play a critical role in addressing the unmet needs of AD patients with localized, moderate to severe symptoms, where fast-acting treatments are crucial, and systemic side effects need to be minimized.
Dr. Justin Ko, a board-certified dermatologist based in the San Francisco Bay Area, expressed optimism about the potential of CGB-500, noting, “This topical solution offers an exciting new option for patients who need rapid, localized relief while potentially avoiding the systemic side effects associated with other therapies.”
Nitin Joshi, Ph.D., CEO of CAGE Bio, emphasized the significance of the company’s ionic liquid platform in developing effective, targeted topical treatments. “With the Phase 2b trial now underway, we are one step closer to revolutionizing the treatment of atopic dermatitis,” Joshi said.
Atopic dermatitis, a chronic inflammatory skin condition, affects millions of people worldwide. While treatment options for patients with localized, moderate to severe symptoms remain limited, CGB-500 aims to bridge this gap by offering a highly effective topical therapy with minimal systemic exposure.
CAGE Bio continues to focus on advancing its clinical programs, aiming to provide patients with innovative treatments that combine the efficacy of biologics with the safety of topical therapies.
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