Aditxt to Initiate First-In-Human Clinical Trials with its Therapeutics Programs in Psoriasis by Year-End
Aditxt Therapeutics, Inc. (ADTX) announced plans to initiate First-In-Human clinical trials for its psoriasis treatment utilizing the Apoptotic DNA Immunotherapy™ (ADi™) technology, aimed at reprogramming the immune system. These trials are set to commence in Q4 2021, following regulatory submission processes in Germany. ADi™ has shown promise in pre-clinical models, demonstrating reductions in skin thickening associated with psoriasis. The agreement with a regulatory consultant is a significant step toward advancing this therapeutic program.
- Initiation of First-In-Human clinical trials for psoriasis by Q4 2021.
- ADi™ technology shows efficacy in pre-clinical models for psoriasis.
- Agreement with regulatory consultant to navigate clinical trial processes.
- Dependence on successful regulatory navigation and trial results.
- Potential delays if the IND application faces regulatory hurdles.
MOUNTAIN VIEW, Calif., March 24, 2021 /PRNewswire/ -- Aditx Therapeutics, Inc. (Aditxt) (the "Company") (Nasdaq: ADTX), a biotech innovation company focused on improving the health of the immune system, today announced that its AditxtReprogrammingTM Therapeutics Division is preparing its therapeutic program for psoriasis for First-In-Human clinical trials. The trials, which are planned to begin in Q4 2021, will evaluate clinical safety and efficacy of Aditxt's new approach to reprogramming and retraining the immune system.
The Trials will be evaluating a nucleic acid-based technology named Apoptotic DNA Immunotherapy™ (ADi™). Aditxt's ADi™ technology utilizes a novel approach that mimics the way the body naturally induces tolerance to its own tissues (therapeutically induced immune tolerance) and is protected with approximately 90 U.S. and international patents. ADi™ has demonstrated 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. Psoriasis is the first indication being targeted for clinical trial in the AditxtReprogrammingTM therapeutics pipeline. Other candidates that are advancing toward clinical trials include ADi™ for type 1 diabetes and skin allografting.
Amro Albanna, co-founder and Chief Executive Officer of Aditxt, stated, "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 U.S. 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."
For more information about AditxtReprogrammingTM, visit aditxt.com/.
About Aditx Therapeutics
Aditxt is developing technologies specifically focused on improving the health of the immune system through immune monitoring and reprogramming. The Company's immune monitoring technology is designed to provide a personalized comprehensive profile of the immune system. The Company's immune reprogramming technology is designed to retrain the immune system to induce tolerance with an objective of addressing rejection of transplanted organs, autoimmune diseases, and allergies. For more information, please visit: www.aditxt.com
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Forward looking statements include statements regarding the Company's intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the Company's ongoing and planned product development; the Company's intellectual property position; the Company's ability to develop commercial functions; expectations regarding product launch and revenue; the Company's results of operations, cash needs, spending, financial condition, liquidity, prospects, growth and strategies; the industry in which the Company operates; and the trends that may affect the industry or the Company. Forward-looking statements are not guarantees of future performance and actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, as well as those risks more fully discussed in the section entitled "Risk Factors" in the Company's prospectus, dated February 10, 2021, that was filed with the Securities and Exchange Commission under File No. 333-252711, as well as discussions of potential risks, uncertainties, and other important factors in the Company's subsequent filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
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SOURCE Aditxt
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