FDA Approves Direct Biologics to Proceed with a Landmark
Phase 3 Acute Respiratory Distress Syndrome (ARDS) Trial
AUSTIN, Texas, April 21, 2022
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.”
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.