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Aditxt | 8-K: Current report

SEC ·  Dec 13, 2024 05:16

Summary by Futu AI

Aditxt announced that its subsidiary Adimune has successfully completed preclinical efficacy and safety studies for ADI-100, an antigen-specific gene therapy for immune modulation. The therapy demonstrated potential in treating Type 1 Diabetes, Psoriasis, and Stiff-Person Syndrome without impairing overall immune responsiveness.Preclinical data showed ADI-100's ability to reverse hyperglycemia, restore islet cell mass, and transfer protective immune modulation in diabetes models. It also prevented hyperglycemia in 70% of treated mice for over 300 days when combined with checkpoint inhibitors. Toxicology studies confirmed the therapy's safety, with no significant adverse effects observed.Adimune aims to submit a Clinical Trial Application/Investigational New Drug application in H2 2025 to initiate first-in-human trials. The company views ADI-100 as a potential paradigm shift in autoimmune disease treatment, targeting a market valued at $84.12 billion. Adimune's progress positions it as a frontrunner in developing innovative therapies for autoimmune diseases.
Aditxt announced that its subsidiary Adimune has successfully completed preclinical efficacy and safety studies for ADI-100, an antigen-specific gene therapy for immune modulation. The therapy demonstrated potential in treating Type 1 Diabetes, Psoriasis, and Stiff-Person Syndrome without impairing overall immune responsiveness.Preclinical data showed ADI-100's ability to reverse hyperglycemia, restore islet cell mass, and transfer protective immune modulation in diabetes models. It also prevented hyperglycemia in 70% of treated mice for over 300 days when combined with checkpoint inhibitors. Toxicology studies confirmed the therapy's safety, with no significant adverse effects observed.Adimune aims to submit a Clinical Trial Application/Investigational New Drug application in H2 2025 to initiate first-in-human trials. The company views ADI-100 as a potential paradigm shift in autoimmune disease treatment, targeting a market valued at $84.12 billion. Adimune's progress positions it as a frontrunner in developing innovative therapies for autoimmune diseases.

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