CAGE Bio Reports Strong Phase 2b Results for CGB-500 in AD

This week, CAGE Bio announced promising topline results from its phase 2b dose-ranging study of CGB-500, a novel ionic liquid–based topical therapy for patients with atopic dermatitis (AD).¹ The trial demonstrated strong efficacy, rapid itch relief, and a favorable safety profile, underscoring the potential of this investigational therapy for individuals with moderate to severe disease affecting less than 10% of body surface area (BSA)—a population with limited treatment options.

Atopic dermatitis is one of the most prevalent chronic inflammatory skin conditions, affecting over 200 million people globally. Among these, approximately 92% have involvement of less than 10% BSA, yet about 40% fall into the moderate to severe disease category. In the United States alone, an estimated 6.6 million individuals live with moderate to severe AD, the majority of whom have limited disease extent but lack effective localized therapies. Systemic treatments are frequently prescribed in such cases, despite the relatively small affected skin area.²

"This is a highly significant advancement. There are limited topical options for patients with moderate to severe atopic dermatitis (AD) with low body surface area involvement, and physicians often prescribe systemic medications. CGB-500 may offer a much-needed alternative for localized skin-directed treatment for these patients. The rapid and sustained itch relief reported by patients and high rate of disease improvement as adjudicated by the study dermatologists makes this an attractive proposition" said Justin Ko, MD, MBA, Board-Certified Dermatologist and Scientific Advisory Board chair for CAGE Bio, in a news release.

Study Design and Patient Population
The phase 2b trial enrolled 180 patients aged 12 years and older across 16 clinical sites in the United States. The cohort reflected real-world AD severity distribution: approximately 85% had moderate disease, 9% mild, and 6% severe, all with less than 10% BSA involvement. The randomized, double-blinded study evaluated the efficacy and safety of CGB-500 compared with vehicle.

Efficacy Outcomes
The trial met its primary and secondary endpoints, showing significant improvements compared with vehicle. Notable findings included:

• Investigator’s Global Assessment (IGA) success: 59% of patients achieved clear or almost clear skin with at least a two-grade improvement, a rate higher than previously reported for topical therapies in AD.
• Itch reduction: 71% of patients achieved at least a 4-point reduction on the Peak Pruritus Numerical Rating Scale (PP-NRS).
• Complete itch resolution: 35% of patients reported a “0” itch score, indicating total resolution of itch symptoms.

Investigators highlighted that these outcomes establish a new benchmark for topical therapy efficacy in AD, particularly for patients with localized disease who would otherwise require systemic therapy.

Safety Profile
Researchers stated CGB-500 was generally well tolerated with no new or unexpected safety concerns identified in the trial. The safety profile aligns with that of topical therapies, offering reassurance regarding its potential for long-term use.

Expert Perspectives

Samir Mitragotri, PhD, inventor of the ionic liquid platform, spoke to its success in a release from the company: "Ionic liquid technology enables local delivery of medicine at efficacy levels comparable to systemic drugs, but with a safety profile similar to topicals. It is exciting to see this technological advantage translated into benefit for patients."

"These results mark an important milestone for CAGE Bio and, most importantly, for patients living with this burdensome disease. These data further strengthen our belief in our mission to provide high efficacy targeted and localized treatment of immunological skin diseases," said Nitin Joshi, PhD, CEO of CAGE Bio, in the release. "We are excited to rapidly advance CGB-500 into Phase 3 trials and towards potential registration."

Conclusion
The positive phase 2b results for CGB-500 highlight its potential as a best-in-class topical therapy for patients with moderate to severe AD and limited BSA involvement. With its strong efficacy, rapid itch relief, and favorable safety profile, CGB-500 may represent a significant step forward in localized management of atopic dermatitis.

References

1. CAGE Bio reports strong results from its phase 2b atopic dermatitis trial. News release. CAGE Bio. September 4, 2025. Accessed September 5, 2025. https://www.prnewswire.com/news-releases/cage-bio-reports-strong-results-from-its-phase-2b-atopic-dermatitis-trial-302547128.html?tc=eml_cleartime
2. Eczema Statistics. Allergy and Asthma Network. Accessed September 5, 2025. https://allergyasthmanetwork.org/what-is-eczema/eczema-statistics/