CAGE Bio Announces Phase 2b Trial for CGB-500 (1% Tofacitinib), a Breakthrough Topical JAK Inhibitor for Moderate to Severe Atopic Dermatitis

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CAGE Bio Announces Phase 2b Trial for CGB-500 (1% Tofacitinib), a Breakthrough Topical JAK Inhibitor for Moderate to Severe Atopic Dermatitis

TECHNOLOGY 09.01.2025

CAGE Bio, Inc., a clinical-stage biotechnology company advancing innovative therapies for high incidence immuno-dermatological disorders, today announced the initiation of a Phase 2b dose-ranging trial for its CGB-500 product. This topical JAK inhibitor ointment, developed using CAGE Bio's proprietary ionic liquid technology, represents a potential breakthrough for low body surface area (BSA), moderate to severe atopic dermatitis (AD) condition.

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CGB-500 delivers medicine directly through the skin, combining high efficacy with minimal systemic exposure. Results from the 2024 Phase 2a trial showed efficacy comparable to biologics, outperforming current best-in-class topical treatments while maintaining a significantly lower side-effect profile. Specifically, CGB-500 had an 8-week treatment success of 95% (IGA score of "0" or "1" and > 2 grade improvement ).

This larger Phase 2b trial (n=180) will focus on optimizing dosing regimens and further assessing the safety and efficacy of CGB-500. This pivotal step underscores CAGE Bio's commitment to addressing the unmet needs of patients with moderate to severe AD and low body surface area (BSA) involvement, where treatment speed and efficacy must be balanced with the cost of systemic exposure and side effects.

"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 San Francisco Bay Area.

"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," said Nitin Joshi, Ph.D., CEO of CAGE Bio.

Atopic dermatitis is a chronic inflammatory skin condition affecting millions globally. Patients with highly localized, moderate to severe symptoms face limited treatment options. CGB-500 seeks to fill this gap, offering a high efficacy alternative with dramatically lower systemic exposure.

CAGE Bio remains committed to advancing clinical programs that deliver transformative therapies (efficacy of a biologic with safety of a topical ) for immuno-dermatological disorders.

About CAGE Bio
CAGE Bio is a clinical-stage biotechnology company developing innovative localized therapies for immune-mediated dermatological conditions. Its proprietary ionic liquid technology ensures effective drug delivery to target areas with minimal systemic exposure, improving patient outcomes.

Phone: +1 (650) 996-1845
email. [email protected]

SOURCE: CAGE Bio Inc.

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Arizona Tribune - CAGE Bio Announces Phase 2b Trial for CGB-500 (1% Tofacitinib), a Breakthrough Topical JAK Inhibitor for Moderate to Severe Atopic Dermatitis

CAGE Bio Announces Phase 2b Trial for CGB-500 (1% Tofacitinib), a Breakthrough Topical JAK Inhibitor for Moderate to Severe Atopic Dermatitis

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