CAGE Bio Initiates Clinical Trial for DNA Aptamer Therapy in Vitiligo

CAGE Bio Inc., a clinical-stage biotechnology company focused on immunomodulatory therapies for dermatological diseases, announced the initiation of a randomized, double-blind, vehicle-controlled clinical trial evaluating its proprietary DNA Aptamer therapy, CGB-600, for the treatment of vitiligo.

About CGB-600

CGB-600 is a first-in-class DNA Aptamer and new chemical entity, licensed from TAGCyx Biotechnologies Inc., Japan. It is designed to:

• Selectively bind to interferon gamma
• Downregulate autoimmune activity involved in melanocyte destruction
• Target disease-specific immune pathways to provide durable re-pigmentation with potentially fewer side effects than current therapies

Dr. Nitin Joshi, CEO of CAGE Bio, said:

"Vitiligo remains an area of high unmet medical need with limited durable treatment options. Our DNA Aptamer program opens an entirely new therapeutic modality in immune-targeted skin therapeutics. Preclinical studies suggest CGB-600 can achieve significant and sustained re-pigmentation, which could be transformative for patients and providers."

Advances in Drug Delivery

Dr. Samir Mitragotri, Professor of Bioengineering at Harvard University, commented on the trial’s significance:

"Nucleic acids are large, charged molecules, and their localized, topical delivery is a huge unmet need. Delivering a drug of this size non-invasively into the skin represents a major advancement in drug delivery."

Dr. Mitragotri, who pioneered the ionic liquid drug delivery platform, continues to advance the science of topical delivery for therapeutic applications.

Clinical Trial Design

The trial will enroll 36 adult patients with nonsegmental facial vitiligo and is structured as a randomized, double-blind, vehicle-controlled study.

• Primary endpoints: Tolerability and improvement in F-VASI (Facial Vitiligo Area Scoring Index) at Week 24
• Top-line results: Expected in Q3 2026

The study aims to evaluate whether CGB-600 can provide enhanced selectivity, lower side effects, and sustained re-pigmentation benefits compared with existing treatment options.

Market Context

The global vitiligo treatment market is projected to exceed $2 billion in the coming years. While recent advances such as JAK inhibitors have expanded treatment possibilities, options providing long-lasting benefits remain limited. CGB-600 offers a differentiated approach through immune-targeted therapy and nucleic acid delivery platforms.

About CAGE Bio

CAGE Bio Inc. is a clinical-stage biotechnology company developing next-generation dermatology and immunology therapies. Its pipeline focuses on nucleic acid-based therapies and targeted delivery platforms, addressing inflammatory and autoimmune skin disorders.

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