Direct Biologics Reveals Successful Outcomes from EXIT COVID-19 Phase II Clinical Trial
AUSTIN, Texas, April 6, 2022
Direct Biologics, a regenerative biotechnology company with a lifesaving mesenchymal stem cell (MSC) derived extracellular vesicle (EV) platform technology, announces topline results from its first-in-human, multicenter, Phase II double-blind, placebo-controlled, randomized clinical trial, EXIT COVID-19, today which used the EV product ExoFlo to treat COVID-19 related Acute Respiratory Distress Syndrome (ARDS).
“Overall, ExoFlo demonstrated a robust safety and efficacy profile that warrants further clinical investigation with a pivotal Phase III study. In addition to an unequaled reduction in 60-day mortality rate of 37.6% in comparison to placebo, no reportable adverse events were observed,” said Dr. Vikram Sengupta, Chief Medical Officer. “ExoFlo also substantially outperformed placebo with respect to time to discharge and ventilator free days. Additionally, subgroup analysis revealed a larger mortality benefit among patients who were severely hypoxic at randomization,” he said.
“With the recent emergence of the BA.2 variant, healthcare providers across the US are preparing for another wave of hospitalizations caused by COVID-19 related ARDS. Under the present standard of care, the mortality rate still exceeds thousands of lives per week and ARDS due to COVID-19 remains a leading cause of death in the US. There is still a profound unmet need for a novel therapeutic to address this problem, and we believe that ExoFlo is the solution,” said Dr. Sascha Sengupta, Associate Chief Medical Officer.
ExoFlo is an acellular human bone marrow mesenchymal stem cell (MSC) derived extracellular vesicle (EV) product produced with a proprietary EV platform technology by Direct Biologics, LLC. Containing signaling molecules from bone marrow MSCs, ExoFlo harnesses the anti-inflammatory and regenerative properties of bone marrow MSCs without the cost, complexity, and limitations of scale associated with stem cell transplantation.
Physicians can learn more and may request information on becoming a study site at http://www.clinicaltrials.gov. For more information on Direct Biologics and regenerative medicine, visit: https://directbiologics.com.
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 biological products. The Company was created to expand the science of cutting-edge biologic technologies. Direct Biologics’ 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. For more information, visit https://directbiologics.com.
Phone: 1-800-791-1021
Email: info@directbiologics.com
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 the application for a Phase I/II trial under an Investigational New Drug (IND) protocol for the use of ExoFlo™ in the treatment of mild-to-moderate COVID-19. This is Direct Biologics’ third FDA approved IND clinical trial, and it represents the very first IND approved by FDA to investigate the use of extracellular vesicles (EVs) to treat mild-to-moderate COVID-19.