Summary by Moomoo AI
Aditxt's subsidiary Adimune has successfully completed preclinical efficacy and safety studies for its ADI-100 immune modulation therapeutic platform. The company plans to submit Clinical Trial Application/IND applications in H2 2025 for first-in-human trials targeting Type 1 Diabetes, Psoriasis, and Stiff-Person Syndrome, with the latter in collaboration with Mayo Clinic.Preclinical studies demonstrated ADI-100's ability to achieve antigen-specific tolerization without compromising immune system functionality. In Non-Obese Diabetic mice, the therapy prevented hyperglycemia in 70% of treated subjects, with protection lasting over 300 days. Safety studies confirmed no detectable plasmid persistence, no anti-plasmid antibodies formation, and no significant adverse effects.The therapy represents a potential paradigm shift in autoimmune disease treatment, targeting a market valued at $84.12 billion. ADI-100 consists of two DNA molecules designed to restore immune tolerance through precision immune reprogramming, potentially eliminating the need for immunosuppressants. GMP drug substances have been manufactured and stability studies are currently underway.
