An Inside Look in the Development of CGB-500 For Atopic Dermatitis Treatment

In an interview with Dermatology Times, Nitin Joshi, PhD, CEO and co-founder of CAGE Bio Inc., shared insights into the company's journey in dermatological drug development. He is gearing up to head to the 2024 American Academy of Dermatology Meeting in San Diego, California March 8-12 to explain the advancements in the company’s formulation in clinical trials. Established 5 years ago, CAGE Bio has utilized an ionic liquid formulation of 1% tofacitinib. The ionic liquid technology was developed at the University of California, Santa Barbara, in collaboration with Los Alamos National Labs and Northern Arizona University to explore topical options for patients with atopic dermatitis. This formulation has been labeled as CGB-500 in early clinical trials. Joshi highlighted the intricate balance required to breach the skin barrier, emphasizing the need for a biocompatible solution.

"The skin is the largest organ with a significant barrier for entry. Our focus is to deliver drugs across that barrier efficiently," Joshi said.

In phase 2 results, all primary and secondary endpoints were achieved with “an average reduction of 98% in lesional Eczema Area Severity Index (EASI) scores for the active group compared to 28% in the vehicle group at 8 weeks. Clear or almost clear ratings were achieved for 95% of patients in the active group compared to 24% in the vehicle group. Trial participants treated with CGB-500 achieved >90% improvement in their EASI scores throughout the study, and it was well-tolerated with zero significant adverse events reported.¹

"Other technologies [versus ionic liquids] are not as efficient in getting the drug right to the place where they need to be. Our ionic liquids are superior, allowing us to deliver not just tiny, small drugs but even large molecules efficiently," Joshi explained. He remains cautiously optimistic, acknowledging the potential variability in larger and diverse patient populations as additional trials get underway.

Justin Ko, MD, MBA, chair of CAGE Bio's scientific advisory board, applauded the potential of ionic-liquid-based formulations after phase 2 results were released for atopic dermatitis. "Ionic liquids are very efficient at interacting with lipids. We get 20 times higher exposure in the skin where the drug needs to be and five to seven times lower exposure in systemic circulation," Joshi added, elucidating the advantages over traditional formulations.

Joshi's vision for the impact of CGB-500 on dermatological treatments is expansive. "Our goal is to achieve biologic-level efficacy with the safety of a topical," he declared. With plans to extend CGB-500's application to alopecia areata and vitiligo, Joshi underscored the potential for localized treatments. He stated, "The big thing is delivering large molecules into the skin—nucleic acids, SiRNA, antisense oligonucleotides, and potentially even biologics. That's very personalized localized treatment."

In addressing dermatology professionals, Joshi emphasized the importance of localized treatment. "Topicals are essential in proper patient care. We want to give you highly effective topical products, so you can reserve systemic drugs for those cases where localized treatment is not practical," he urged.Joshi expressed the company's commitment to changing the treatment landscape. "We want to bring reasonable cost and strong efficacy, changing the order at which patients are treated," he concluded.

Reference

1. CAGE Bio announces positive topline results from its double-Blind phase 2 study evaluating an ionic liquid formulation of 1% tofacitinib in patients with atopic dermatitis. Cage Bio Inc. August 3, 2023. Accessed March 4, 2024. https://www.accesswire.com/772102/cage-bio-announces-positive-topline-results-from-its-double-blind-phase-2-study-evaluating-an-ionic-liquid-formulation-of-1-tofacitinib-in-patients-with-ato