CAGE Bio, Inc., a biotechnology company focused on immuno-dermatological disorders, has announced the initiation of a Phase 2b clinical trial for CGB-500, a topical Janus kinase (JAK) inhibitor, in patients with moderate to severe atopic dermatitis (AD). The trial aims to optimize dosing and further assess the safety and efficacy of the ointment, which leverages CAGE Bio's proprietary ionic liquid technology for targeted drug delivery.
CGB-500: A Novel Topical Approach
CGB-500 is designed to deliver medication directly through the skin, minimizing systemic exposure. This approach is particularly relevant for patients with localized atopic dermatitis, where systemic therapies may pose unnecessary risks. The Phase 2b trial, involving 180 participants, will evaluate various dosing regimens to balance efficacy and side effects.
Promising Phase 2a Results
In a 2024 Phase 2a trial, CGB-500 demonstrated an 8-week treatment success rate of 95%, based on an Investigator's Global Assessment (IGA) score of "0" or "1" and a greater than 2-grade improvement. These results were comparable to those achieved with biologics and surpassed existing topical treatments, while maintaining a lower side-effect profile.
Addressing Unmet Needs in Atopic Dermatitis
Atopic dermatitis is a chronic inflammatory skin condition affecting millions worldwide. Patients with moderate to severe symptoms, particularly in cases with low body surface area (BSA) involvement, often face limited treatment options. CGB-500 seeks to address this gap by providing a high-efficacy alternative with reduced systemic exposure.
Expert Commentary
"CGB-500 offers a promising solution for patients seeking rapid and effective localized relief potentially avoiding systemic therapies and their associated side-effects," said Dr. Justin Ko MD, a board-certified dermatologist in the San Francisco Bay Area.
Nitin Joshi, Ph.D., CEO of CAGE Bio, added, "Our ionic liquid platform continues to demonstrate its potential in enabling highly effective and targeted topical therapies. With the Phase 2b trial now underway, we are one step closer to transforming how atopic dermatitis is treated."
