Aditx Therapeutics Inc (Nasdaq: ADTX), a biotech innovation company, announced on Wednesday that its AditxtReprogrammingTM Therapeutics Division is preparing its therapeutic program for psoriasis for First-In-Human clinical trials.
The trials are scheduled to commence in the fourth quarter of 2021. They will assess clinical safety and efficacy of the company's new approach to reprogramming and retraining the immune system. They will be evaluating a nucleic acid-based technology named Apoptotic DNA Immunotherapy (ADi). The technology has showcased efficacy in several pre-clinical disease models including psoriasis, in which a reduction in skin thickening and scaling, and modulation of key protein markers were observed.
Aditxt has signed an agreement with a regulatory consultant based in Munich, Germany, which will play a central role in navigating the first AditxtReprogrammingTM therapeutic program through the clinical trial and regulatory process. The firm will work with the Aditxt's AditxtReprogrammingTM team to submit an Investigational New Drug application (IND) to the regulatory agency in Germany.
Amro Albanna, co-founder and chief executive officer of Aditxt, said, 'This agreement represents a major step forward as we begin advancing ADi for psoriasis through the regulatory process and towards the start of clinical trials. Our co-founder and chief innovation officer, Dr Shahrokh Shabahang, and his product development team have experience working within the regulatory framework of both the US and Europe and are leading all preparation, execution, regulatory and budgetary matters relating to Aditxt's planned 2021 Phase I/IIA clinical trials for psoriasis. We are excited to begin this phase of Aditxt's development after our initial focus on launching the AditxtScoreTM platform for monitoring the immune system.'
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