Biotech firm Aditxt has announced significant progress in its autoimmune therapy development following a Mayo Clinic-led study that validated preclinical findings for ADI-100. The study confirmed the therapy candidate's ability to induce immune tolerance to glutamic acid decarboxylase (GAD), a key trigger in autoimmune conditions including type 1 diabetes and stiff person syndrome.
The research revealed that ADI-100 does not enhance harmful immune activity. Instead, it promotes antigen-specific suppression through tolerogenic dendritic cells, a potentially transformative approach to managing autoimmune disorders. This mechanism suggests the therapy could offer a more targeted and precise method of immune system intervention.
With Good Manufacturing Practice (GMP) manufacturing completed and stability testing in progress, Aditxt is preparing regulatory filings in the United States and Germany. The company plans to submit these filings in the second half of 2025, which will support upcoming clinical trials for ADI-100.
The breakthrough represents a significant step forward in autoimmune therapy research. By targeting the specific immune mechanisms that trigger autoimmune responses, ADI-100 could potentially provide more effective and less invasive treatment options for patients suffering from conditions like type 1 diabetes.
