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DB-5Q is an investigational, acellular, exosome-based therapy developed by Direct Biologics for the treatment of medically refractory Crohn's disease. It is derived from human bone marrow-derived mesenchymal stem cells (bmMSCs) and consists of extracellular vesicles (EVs) that carry a diverse cargo of bioactive molecules, including anti-inflammatory proteins, growth factors, and microRNAs. The therapeutic mechanism involves modulating the immune microenvironment within the gastrointestinal tract to suppress chronic inflammation and promote mucosal healing and tissue regeneration. As an acellular product, DB-5Q aims to provide the immunomodulatory benefits of stem cell therapy without the risks associated with live cell transplantation, specifically targeting patients who have failed standard-of-care biologic treatments.
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