The investigational topical drug CGB-500 outperformed efficacy benchmarks while meeting safety endpoints
59% of patients achieved IGA treatment success
71% of patients experienced ≥4-point improvement in worst itch

SAN CARLOS, Calif., Sept. 4, 2025 /PRNewswire/ — CAGE Bio, a biotechnology company advancing ionic liquid–based therapies for immune-mediated skin diseases, today announced positive topline results from its double-blinded, Phase 2b dose-ranging trial of CGB-500 in patients with atopic dermatitis (AD). Globally, AD affects over 200 million people of which ~92% have <10% affected body surface area¹, of which ~40% suffer from moderate to severe disease. In the US alone, 6.6 million people suffer from moderate to severe atopic dermatitis² and an overwhelming number of these have <10% affected body surface area (BSA) with limited effective treatment options.

The Phase 2b study enrolled 180 patients ≥12 years of age at 16 sites across the United States. A large majority of patients (~85%) had moderate AD, while 9% had mild and 6% had severe AD, all with affected body surface area <10%.

The trial met primary and secondary endpoints, demonstrating best-in-class treatment success, rapid itch reduction, and a favorable safety profile.

59% of patients achieved Investigator’s Global Assessment (IGA) treatment success (Clear or Almost Clear with ≥2-grade improvement)—higher than reported by other topical therapies in AD.
71% of patients experienced ≥4-point improvement in worst itch (PP-NRS)
35% achieved complete itch resolution (“0” itch score).

Efficacy results were statistically significant vs. vehicle, setting a new benchmark for treatment success for topical therapies in AD.

“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.

CGB-500 was well tolerated with no new or unexpected safety signals, underscoring its potential as a safe and effective option for long-term management of AD.

“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,” said Dr. Samir Mitragotri, inventor of the ionic liquid platform.

“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. We are excited to rapidly advance CGB-500 into Phase 3 trials and towards potential registration,” said Dr. Nitin Joshi, CEO of CAGE Bio.

CAGE Bio looks forward to sharing the full data at an upcoming scientific congress.

About CAGE Bio

CAGE Bio Inc. is a biotechnology company dedicated to developing innovative therapies for immune-mediated diseases using its proprietary ionic liquid technology platform. The company’s pipeline includes clinical and preclinical assets targeting high-incidence dermatological conditions.

¹Silverberg, J. I., et al., https://doi.org/10.1089/derm.2022.29015.jsi

²https://allergyasthmanetwork.org/what-is-eczema/eczema-statistics/

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