Direct Biologics, a regenerative biotechnology company with a groundbreaking extracellular vesicle (EV) platform technology, announced today that the FDA has approved the company to proceed with its Phase 3 clinical trial using its investigational EV drug, ExoFlo, to treat Acute Respiratory Distress Syndrome (ARDS) due to Covid-19. Direct Biologics is the first and only EV company to receive FDA Phase 3 approval for an Investigational New Drug (IND) indication to date.  

The Phase 3 trial will be conducted under the auspices of the first Regenerative Medicine Advanced Therapy (RMAT) designation approved by the FDA for an EV therapeutic, making Direct Biologics one of only 70 companies in the history of the FDA to have been officially awarded RMAT.  Like the fast track and breakthrough designations, the RMAT was created by the FDA to expedite approval for promising regenerative medicines which demonstrate the ability to treat serious life-threatening diseases.    

“Receiving FDA approval for Phase 3 is a key milestone for Direct Biologics,” said Mark Adams, Co-Founder and CEO.  “Coupled with the RMAT designation, we are now on an accelerated path towards commercialization with a potential life-saving drug—ExoFlo.  This Phase 3 trial titled “Extinguish Covid-19” is an international, multicenter, double-blind, randomized, placebo-controlled Phase 3 trial.  Our objective is to enroll patients with ARDS in hospital sites across US, Spain, India, Jordan, Egypt, Lebanon, and South Africa, and to demonstrate a significant mortality reduction following treatment with ExoFlo compared to standard of care alone.  As pioneers in the field of regenerative medical therapies, we at Direct Biologics are changing the future of medicine.”  

“Whether Covid-19 remains a pandemic or becomes an endemic, one area of unmet need remains the same: an effective therapeutic for ARDS. People over age 65 and those with comorbidities, once infected with SARS-CoV-2, will always be vulnerable to progression to severe infection and ARDS,” said Joe Schmidt, Co-Founder and President.  “Revealing robust safety and a promising 60-day mortality reduction, our Phase 2 trial showed that ExoFlo can make a profound life-saving difference for patients hospitalized with ARDS. Receiving FDA approval to proceed to Phase 3 is a monumental achievement because there is no known treatment for ARDS. Physicians and patients across the world have long been waiting for a solution.”   

“Working to develop ExoFlo is a privilege,” said Dr. Vik Sengupta, Chief Medical Officer.  “The growing body of clinical data indicates that ExoFlo is a drug that brings hope to the treatment of a disease for which the standard of care has not improved in decades. This hope is most poignantly captured by the stories of patients who have received ExoFlo for treatment. Just last week, a woman in Virginia was reunited with her children after languishing on mechanical ventilator for 2 months due to developing ARDS induced by Covid-19.  But in a final attempt to save the patient’s life, the ICU physicians petitioned to treat her with ExoFlo under compassionate use, and she made a miraculous recovery.  There are millions of people like her who never make it out of the hospital.  We want to change that story by establishing ExoFlo as the gold standard treatment for ARDS and making it accessible to patients in hospitals around the world.”