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 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 US 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.