Direct Biologics, a market-leading innovator and cGMP manufacturer of regenerative biologic products, announced today that the U.S Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to conduct a Phase I/II clinical trial using ExoFlo™ in the treatment of Acute Respiratory Distress Syndrome (ARDS). The Company now has four IND protocols approved by the FDA. This trial represents its first non-COVID-19-related investigational approval. Direct Biologics is the only EV company with INDs approved for the full breadth of COVID-19 indications, as well as ARDS.
Treatment with bone marrow mesenchymal stem cells (bmMSCs) has already shown promise in the treatment of COVID-19 associated ARDS, other sepsis-based ARDS, and many hyperinflammatory disease states. Classic ARDS can be caused by pneumonia, flu, aspiration, sepsis, pancreatitis, and trauma. Despite decades of research involving investigational products, supportive care with mechanical ventilation remains the mainstay of treatment and the morbidity and mortality remain high.
Mark Adams, Co-Founder and Chief Executive Officer, stated, "ARDS affects over 220,000 patients in the U.S. and over 800,000 globally, and no standard, approved treatments exist for ARDS at this time. With a mortality rate of 40-50%, ARDS represents a significant unmet medical need. We are extremely excited to initiate this trial and are optimistic that the study outcomes will provide further support for ExoFlo as an effective adjunct treatment for ARDS patients."
Joe Schmidt, Co-Founder and President, added, "The findings from this study will also allow us to explore additional pulmonary applications such as other chronic diseases and acute lung injuries. We are confident that the data will further provide support of ExoFlo in a wide range of therapeutic conditions."
Direct Biologics plans to initiate the ARDS Phase I/II trial later this year in addition to two other recently approved IND applications for post-acute COVID-19 syndrome and chronic post-COVID-19 as well as mild-to-moderate COVID-19. In Spring 2021, under its first IND, the Company successfully completed two additional clinical trials evaluating ExoFlo for the treatment of COVID-19 related acute respiratory distress syndrome (ARDS) in inpatient and ICU settings under its first double-blinded, placebo-controlled, randomized controlled trial and an expanded access protocol for compassionate use.
About ExoFlo
ExoFlo is an investigational new drug that has not been approved or licensed by the FDA. It is an extracellular, vesicle based biologic product isolated from human bone marrow mesenchymal stem or stromal cells (MSCs). ExoFlo provides signaling proteins that have been shown to modulate inflammation and may stimulate bioactivity and direct cellular communication.
About Direct Biologics
Direct Biologics, LLC, is headquartered in Austin, Texas, with an R&D facility located at the University of California, and an Operations and Order Fulfillment Center located in St. Louis, Missouri. Direct Biologics is a market-leading innovator and cGMP manufacturer of regenerative medical products, including a robust line of extracellular vesicle-based bio pharma products.
The Company was created to expand the science of cutting-edge biologic technologies. Direct Biologic's management team holds extensive collective experience in biologics research, development, and commercialization, making the Company a leader in the evolving, next-generation segment of the biotherapeutics industry. Direct Biologics is dedicated to pursuing additional clinical applications of ExoFlo through the FDA's investigational new drug application process.
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