Aditxt®, Inc. (NASDAQ: ADTX) (“Aditxt” or the “Company”), a global innovation company focused on therapeutics and technologies that modulate and monitor the immune system, today announces that its subsidiary Adimune™, Inc. (“Adimune”), has signed a clinical trial agreement with Mayo Clinic to advance clinical studies targeting autoimmune diseases of the central nervous system (“CNS”) with the initial focus on the rare, but debilitating, autoimmune disease Stiff Person Syndrome (“SPS”). Adimune was founded earlier this year to lead Aditxt’s immune modulation therapeutic programs.
For the past 18 months, Aditxt has been preparing to launch its first immune modulation product candidate, ADI™-100, targeting several clinical trials to demonstrate its safety and indications of efficacy. ADI-100 is designed to tolerize against an antigen known as glutamic acid decarboxylase (“GAD”), which is implicated in type-1 diabetes, psoriasis, and in many autoimmune diseases of the CNS.
“We are extremely pleased about having the opportunity to work with Mayo Clinic on trying to restore immune tolerance in patients suffering from devastating progressive autoimmune central nervous system disorders,” said Dr. Joachim Friedrich Kapp, the co-CEO of Adimune. “The collaboration will include both pre-clinical and clinical studies and builds on Adimune’s current efforts to advance the full pre-clinical and clinical programs of ADI-100. We believe that the pre-clinical studies will help us to expand on the understanding of the technology, specifically the mechanism of action which induces antigen-specific immune tolerance without impairing the responsiveness of the immune system to fight infections and cancers.”
Adimune plans to initiate clinical studies using ADI-100, targeting autoimmune diseases of the CNS that are mediated by GAD, starting with SPS. According to the National Organization of Rare Diseases, the exact incidence and prevalence of SPS is unknown; however, one estimate places the incidence at approximately 1 in 1 million individuals in the general population. The clinical trial is expected to begin in 2023 with enrollment of approximately 10-15 patients, some of whom may also suffer from type-1 diabetes.
“With autoimmune disorders of the central nervous system, including multiple sclerosis and other rare diseases affecting millions of people, this step supports our mission of ‘Making Promising Innovations Possible, Together,’” says Adimune Co-CEO and Aditxt Co-Founder, CEO and Chairman, Amro Albanna.