Direct Biologics Initiates Patient Enrollment in the Phase II EXIT COVID-19 Clinical Trial
Phase II Clinical Trial Initiated for ExoFlo Extracellular Vesicles in the Treatment of COVID-19
AUSTIN, Texas, Sept. 9, 2020 /PRNewswire/ -- Direct Biologics, LLC announced the launch today of EXIT COVID-19, their Phase II, multi-center clinical trial examining the use of ExoFlo™ extracellular vesicles to treat COVID-19 associated acute respiratory distress syndrome (ARDS). Preclinical studies of these extracellular vesicles secreted by bone marrow-derived mesenchymal stem cells (bmMSCs) suggest that they may have the ability to downregulate inflammation and upregulate tissue repair in humans.
EXIT COVID-19 has initiated enrollment of 75 COVID-19 patients with moderate-to-severe ARDS at multiple research sites across the U.S. The primary efficacy endpoints will be all-cause mortality and median days to recovery.
Chief Medical Officer Vik Sengupta, MD, states, "We have pursued a relentless path since April 2020 when the 24 inpatients were treated, and ExoFlo's potential as a therapeutic countermeasure against severe COVID-19 first became clear. Patients in the U.S. deserve safe, innovative therapies that meet the highest standards of value and evidence-based medicine, and our phase II double-blind, placebo-controlled, randomized clinical trial is the next step in that process. It will continue to be my priority to maintain these standards as we investigate the potential benefit of ExoFlo as a treatment for COVID-19 associated ARDS."
"This signifies an important milestone in the progression of our product platform development to help in the fight against COVID-19," states Joe Schmidt, Co-Founder and President. "This novel therapy has the potential both to improve outcomes for patients and also to reduce overall costs of hospital stays and adjunctive treatments by speeding recovery and reducing the need or length of ICU time."
Mark Adams, Co-Founder and Chief Executive Officer, states, "We are excited to start enrolling patients in the study and look forward to seeing the outcomes of this advanced therapy. We are dedicated to bringing to market a novel treatment at an accelerated pace to help patients suffering from this devastating disease."
ExoFlo is an investigational new drug that has not been approved or licensed by the FDA. It is an extracellular vesicle 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 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 http://www.directbiologics.com.