Transformational Platform for Localized Delivery of Biologics

Delivery Science is a Critical Bottleneck

Skin, the largest organ of the human body is a common target for many immune related diseases such as Atopic Dermatitis (eczema), Rosacea, Alopecia (hair loss), and Vitiligo.  Skin’s layered anatomy presents a tough barrier for many conventional drugs to penetrate and treat these conditions. The newer, more effective drugs tend to be larger, charged molecules and thus are even more challenged. They must be administered systemically (by injection) introducing a risk of unwanted side effects or contraindications that reduce target patient population. CAGE Bio is focused on overcoming this restriction and broadening treatment options.

CAGE Bio was founded on the belief that systemic exposure to drugs should be an exception, not the norm. Their mission is to enable localized treatment with highly effective modern drugs thereby minimizing side effects from systemic exposure.

Ionic Liquid (IL) technology developed by Cage Bio is the key enabler in this pursuit. In only a few years since inception, the CAGE Bio team sought to realize the promise of a novel technology in academic setting to its clinical use at commercial scale. It’s lead program is already in phase 2 clinical study under an open IND.

Ionic Liquids are Changing the World

This Patent-protected Ionic Liquid Platform was invented in the Mitragotri lab at University of California.  Professor Samir Mitragotri is a world-renowned leader in delivery science and currently the chair of biomedical engineering at Harvard University.

Ionic liquids are salts that are liquid at very low temperatures. Their physical properties are such that drugs formulated with ILs can penetrate skin even with a payload of large molecules while retaining biocompatibility. This makes them a powerful and versatile delivery option. CAGE Bio’s Ionic Liquids are formed using ingredients that are classified by the FDA as GRAS (Generally Regarded as Safe) giving them a substantial safety advantage over current options. Indeed, Ionic Liquids’ inherent properties of broad-spectrum antimicrobial agency, exceptional solvation ability, and superior permeation capacity hold promise to transform topical drug discovery and create newer therapeutic options.

Scientists at CAGE Bio have already demonstrated delivery of a wide range of drugs including small molecules, peptides, proteins, and nucleic acids across the outer layer of the skin with minimal impact on its barrier functions and overall health. This enables the company to engineer diverse Ionic Liquids with tailor‐made properties for multiple therapeutic areas.

Capital-efficient Progress to Phase 2

CAGE Bio’s initial focus is on three common skin conditions: rosacea, eczema, and hair loss disorder. These conditions not only have troubling clinical manifestation but also have a huge social impact. Hair loss, rashes, and other blemishes often lead to low self-esteem and cause people to withdraw from society.

The lead program for treatment of inflammatory lesions of rosacea is currently enrolling patients in a phase 2 study. In an earlier phase 1 study, CAGE Bio product showed ~80% reduction in inflammatory lesions over 12 weeks. According to the American Academy of Dermatology, rosacea affects 14 million people in the U.S., between 30-50 years of age. The primary current treatment for moderate to severe rosacea is oral antibiotics. The global rosacea treatment market is growing at 6% per year and expected to reach $4B by 2025.

Enabling Localized Treatment with Topical Biologics

Atopic Dermatitis, or as it’s more commonly known, eczema, is the most common skin disease in the world affecting over 31 million people in the U.S. and hundreds of millions more globally. It is a condition that causes dry skin, rashes over large areas of the body, severe itching, and other symptoms. While most often beginning before age 5, it may persist into adolescence and adulthood. For some people, it flares periodically and then clears up for a time, lying dormant for several years. Current treatment options include Coricosteroids, PDE4 inhibitors, Calcineurin Inhibitors and biologics in a market that already exceeds $5B. CAGE Bio is collaborating to develop the first topical biologic for localized treatment of atopic dermatitis.

Alopecia is a disease that develops when the body attacks its own hair follicles and causes hair loss.   Most people develop alopecia during their childhood or teenage years. Current treatments including minoxidil or regular steroid injections have mixed efficacy rates. The market size for these treatments is nearly $4B annually.  Interferon gamma is a key mediator of immune diseases such as alopecia. CAGE Bio is poised to develop a topical nucleic acid to locally control interferon gamma induced inflammation that results in hair loss. Pre-clinical data demonstrate strong evidence to support advancing this program to human proof of concept.

CAGE Bio’s ionic liquid offers several distinct advantages over current best practice delivery options such as microneedles or systemic administration. Specifically, CAGE Bio can expand access to highly effective treatments which may have been contraindicated for some patients for systemic administration.

The Pipeline

CAGE Bio has begun to enroll patients in Phase 2 trials of the rosacea program after a very successful Phase 1. They are ready to being to establish clinical proof of concept for a topical nucleic acid for hair loss disorder. They are also advancing the Phase 1 program for atopic dermatitis to phase 2. Along the way the company anticipates executing key strategic partnerships for the platform.

If you’d like to learn more about CAGE Bio and the potential they have to change lives using their Ionic Liquid Platform, please contact Steven Saltzstein and he will put you in touch with the company’s leadership.

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