CAGE Bio’s investigational atopic dermatitis (AD) drug CGB-500 outperformed efficacy benchmarks while meeting safety endpoints, according to topline results a Phase 2b dose-ranging tria.
CGB-500 is a novel ionic liquid–based topical therapy for patients with AD.
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 rapid itch reduction and a favorable safety profile. Fully 59% of patients achieved Investigator’s Global Assessment (IGA) treatment success (Clear or Almost Clear with ≥2-grade improvement). In addition, 71% of patients experienced ≥4-point improvement in worst itch (PP-NRS), and 35% achieved complete itch resolution (“0” itch score).
Efficacy results were statistically significant vs. vehicle, the results show. CGB-500 was well tolerated with no new or unexpected safety signals.
“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” says Justin Ko, MD MBA, a Dermatologist at Stanford Medicine in Palo Alto, CA, and Scientific Advisory Board chair for CAGE Bio, in a news release.
“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,” explains Dr. Samir Mitragotri, Inventor of the ionic liquid platform.
CAGE Bio will share the full data at an upcoming scientific congress. The Company plans to advance CGB-500 into Phase 3 trials.
