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

SAN CARLOS, CA and FORT WORTH, TX / ACCESSWIRE / August 3, 2023 / CAGE Bio, Inc. (hereinafter "CAGE Bio") a biotechnology company focused on developing innovative drug therapies for localized treatment of immuno-dermatological disorders, today announced positive results from its randomized, vehicle controlled, phase 2 study evaluating the safety and efficacy of CGB-500, an ionic liquid formulation of 1% Tofacitinib, in patients with Atopic Dermatitis (AD).

The study met all primary and secondary endpoints achieving 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. Treatment success (rating of clear or almost clear with ≥ 2 grade improvement from baseline) was achieved for 95% of the patients in the active group compared to 24% in the vehicle group. Significantly more patients treated with CGB-500 achieved >90% improvement in their EASI score (EASI-90) throughout the study. Notably, 84% of the patients in the active group had a reduction of 4 or greater on the Numeric Rating Scale (NRS) for itching compared to 43% in the vehicle group. Both, CGB-500 and Vehicle, were well tolerated with no treatment emergent adverse events and no reports of pain or skin irritation at the application site. There were no SAEs reported in the study.

The results from the study demonstrate the utility of the ionic liquid platform in generating highly effective topical treatments. The CAGE platform achieves higher local bioavailability without increasing systemic exposure. CAGE Bio is targeting AD patients with moderate to severe symptoms and low body surface area involvement. There is a large unmet need for an effective topical treatment for these patients to avoid or delay the use of systemic therapies.

"Effectiveness and the potential of tofacitinib in treating immune-mediated skin diseases has been known. The strong data from this study further underscore its potential when combined with the right formulation science. Ionic-liquid based formulations of JAK inhibitors like tofacitinib could address a critical need for treating AD patients with higher severity and low BSA involvement", said dermatologist Dr. Justin Ko, chair of CAGE Bio's scientific advisory board. "We are elated with the results from our phase 2 study. This product could fill a key gap in the treatment of AD patients. We remain committed to advancing the development of CGB-500 for AD and multiple other indications that will benefit from localized therapy" said Nitin Joshi, Ph.D., CEO, CAGE Bio.

Atopic Dermatitis (AD) is a chronic inflammatory skin disorder that affects millions of people worldwide. Despite recent advancements in treatment options, patients with low BSA often encounter limited therapeutic choices that avoid systemic exposure, making the results of this trial especially promising.

CAGE Bio plans to initiate dose ranging and registration trials to further validate the efficacy and safety of CGB-500. These pivotal trials will pave the way for regulatory submissions and, ultimately, the potential approval and commercial availability of this groundbreaking therapy.

About CAGE Bio:

CAGE Bio is a clinical stage biotechnology company dedicated to developing and delivering innovative drug therapies for localized treatment of immuno-dermatological disorders. Our mission is to improve lives by developing localized treatment options that are highly effective with significantly lower systemic exposure.

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**Disclaimer:**

This press release contains forward-looking statements about the Phase 2 results of CB-500 with 1% Tofacitinib. These statements are subject to various risks and uncertainties, which may cause actual results to differ materially from those expressed or implied in this press release. Please refer to the company's filings with relevant regulatory authorities for more information on these risks and uncertainties. The information in this press release is as of 02 August 2023 and CAGE Bio undertakes no duty to update such information except as required under applicable law.

SOURCE: CAGE Bio Inc.