The U.S. Food and Drug Administration granted expanded access for a regenerative therapy-based investigational product developed by an Austin-based Direct Biologics LLC called ExoFlo, a treatment for acute respiratory distress syndrome (ARDS) associated with SARS-CoV-2, the virus behind COVID-19.
TrialSite offers the network a brief breakdown of this regenerative therapeutic (e.g. stem cell)-based product.
What is ExoFlo?
An investigational new drug, it’s an extracellular vesicle product isolated from human bone marrow mesenchymal stem or stromal cells (MSCs). ExoFlo provides natural bioactive signals that evidence the ability to modulate inflammation and direct cellular communication.
What does the expanded access protocol offer patients?
This makes ExoFlo available to a broader group of patients with severe COVID-19, many of them who would not meet acceptance criteria for EXIT COVID-19, often under conditions of “compassionate use.”
Why might the timing be good?
According to company co-founder Joe Schmidt this FDA action comes at an opportune time as new COVID-19 surges are coming due to the cold fall and winter seasons.
Is the investigational product involved with a clinical trial?
Yes, the investigational product is under investigation in the Phase 2 EXIST COVID-19 trial. The 60 participant study (NCT04493242) evaluates the safety and efficacy of intravenous administration of bone marrow derived extracellular vesicles (ExoFlo), versus placebo as treatment for moderate-to-severe-Acute Respiratory Distress Syndrome (ARDS) in patients with severe COVID-19. The study started in September and runs through the end of the year.
What are the benefits to physicians treating severe COVID-19 patients?
Now according to Vik Sengupta, MD, and Chief Medical Officer of the company, this expanded access protocol gives physicians an new option for a regenerative therapeutic that way to reverse disease progression for those patients not responding to the standard of care.
What did a local Congressman have to say?
Michael McCaul, a Congressman commented on the recent FDA action, stating, “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 most.”
What are Expanded Access INDs?
They are tools used by the FDA to offer physicians the ability to administer medication to a single patient via direct appeal to the FDA. For example, this most recent approval comes on the heels of multiple approvals for a single patient Emergency Investigational New Drug (eIND) application granted in September and October.
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.