Aditxt Inc (NASDAQ: ADTX) has announced that its therapeutic project Adimmune has finalized a toxicology study showing ADI-100’s safety profile. ADI-100 is Aditxt’s immunotherapeutic technology drug which addresses transplanted organ rejection, skin allografting, allergies, and autoimmune diseases.
Toxicology findings to support submission of IND application for ADI-100
The toxicology data will offer vital supporting evidence for the company to file an Investigational New Drug (IND) application with regulatory bodies. ADI-100 is a truly antigen-specific autoimmune disease treatment.
The company’s SVP of Clinical Development, Joachim Friedrich Kapp, said, “In preparation of the clinical study, we performed a toxicology study and found: no premature death, no signs of local intolerance, no test item-related influence on clinical signs, body weight, and body weight gains, food consumption, biochemistry or urinalysis. No anti-nuclear antibodies, no macroscopic post-mortem findings, no changes in histopathology were noted, confirming the safety profile of our drug product, which we have seen in all pre-clinical experiments before.”
ADI-100 comprises two DNA molecules that combine to re-establish immune tolerance in autoimmune illness and create tolerance for allogeneic skin transplants applied in skin wounds. Immune system modulation through inducing/restoring tolerance is an exceptional action mechanism with potential safety and efficacy benefits for affected patients since there is no immunosuppression involved.
Adimune is making progress in human trials with ADI-100
Amro Albanna, the CEO and co-founder of the company, said that the promising toxicology ADI-100 results indicated the company’s commitment to advancing promising tech to address the growing unmet medical needs of patients with autoimmune diseases and those that need lifesaving organ transplant procedures.
Albanna stated, “We are excited about the progress Adimune™ is making towards human trials, which represents a significant inflection point for the program and Aditxt as a whole. Adimune™ is an example of our business model accelerating promising innovation into commercialization and monetization.”
Kapp explained that, in addition, the drug doesn’t show any general immunosuppressive effect. This was demonstrated in safety studies when using the Listeria model for infection and melanoma models for possible impacts on tumor growth.