Direct Biologics Initiates Patient Enrollment in EXIT COVID-19 Clinical Trial ExoFlo

Direct Biologics announced the launch 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.

"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," Chief Medical Officer Vik Sengupta, MD, said.

"This signifies an important milestone in the progression of our product platform development to help in the fight against COVID-19," said 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."

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.