Direct Biologics, LLC, announced that the FDA has granted expanded access for ExoFlo in the treatment of patients with COVID-19 associated acute respiratory distress syndrome (ARDS).
While Direct Biologics is already enrolling patients in EXIT COVID-19, its national multi-center, Phase II, placebo controlled, randomized clinical trial, the new expanded access protocol will make ExoFlo available to a broader group of patients with severe COVID-19, many of whom would not meet acceptance criteria for EXIT COVID-19, often under conditions of “compassionate use.”
Co-Founder and Chief Executive Officer, Mark Adams, states, “The FDA’s approval of expanded access for ExoFlo signifies a critical milestone in the development of advanced treatment for COVID-19 associated illnesses including ARDS. We are excited to be able to provide our product to patients with ARDS associated with COVID-19 in critical need of treatment.”
“Amid a potential surge in new COVID-19 cases moving into the fall and winter seasons, this approval could not have come at a better time,” notes Joe Schmidt, Co-Founder and President. “Our team is working hard to advance our Phase II EXIT COVID-19 trial to offer additional treatment options.”
“Approval of our expanded access protocol offers an option for doctors to administer ExoFlo as a treatment to reverse disease progression, extending hope to COVID-19 patients who are not responding favorably to standard of care,” states Chief Medical Officer, Vik Sengupta, MD. “We at Direct Biologics are grateful for every opportunity to help these additional patients in need.”
Also in attendance was Congressman Michael McCaul who commented, “I am thrilled to hear a local company from Austin, Texas, has been approved for Expanded Access IND by the FDA. Their product, ExoFlo, will help treat COVID-19 patients who are at risk of severe respiratory infection, which often leads to life-threatening circumstances. Direct Biologics, with support of the FDA, will bring high-class treatments and services to Americans who need them the most.”
This approval comes on the heels of multiple approvals for single patient Emergency Investigational New Drug (eIND) applications granted in September and October. Emergency INDs are a mechanism by which physicians can obtain rapid approval to administer medication to a single patient through a direct appeal to the FDA.
ExoFlo is an investigational new drug that has not been approved or licensed by FDA. It is an extracellular vesicle product isolated from human bone marrow mesenchymal stem or stromal cells (MSCs). ExoFlo provides natural bioactive signals that have been shown to modulate inflammation and direct cellular communication.
About Direct Biologics
Direct Biologics, LLC, is headquartered in Austin, Texas, with a recently expanded 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 regenerative healing by delivering 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 its extracellular vesicle biologic products through the FDA’s investigational new drug application process.