AUSTIN, Texas--(BUSINESS WIRE)-- Direct Biologics LLC, a late-stage biotechnology company leveraging its regenerative medicine platform using extracellular vesicles (EVs) secreted from bone marrow-derived mesenchymal stem cells to address multiple disease indications, announces favorable safety and efficacy data from its ExoFlo^™ expanded access program in hospitalized adult COVID-19 patients with moderate-to-severe acute respiratory distress syndrome (ARDS).

“We are pleased to report compelling findings from more than 100 patients with respiratory failure due to COVID-19 who were treated with ExoFlo as part of our expanded access program. We believe ExoFlo is the first regenerative medicine product candidate to demonstrate this level of tolerability in patients who are critically ill with COVID-19 associated ARDS,” said Mark Adams, Chief Executive Officer of Direct Biologics. “The potential for ExoFlo to treat critically ill patients with COVID-19 associated pulmonary complications represents a powerful advancement in our efforts to combat this disease.”

In January 2021, Direct Biologics initiated a multicenter expanded access program in the United States of intravenous ExoFlo in hospitalized COVID-19 patients with moderate-to-severe ARDS, including patients with respiratory failure who were not eligible to participate in the Company’s Phase 2 or Phase 3 clinical trial. To date, 103 patients have been enrolled and treated in the program. Patients received a 60-minute infusion of ExoFlo-15 mL diluted to 100 mL in normal saline up to three times over the course of one week. In addition, patients received simultaneous standard-of-care treatment for severe-to-critical COVID-19.

All 103 enrolled subjects were evaluated as of February 2023. Upon review by an independent data safety monitoring board, no adverse events or serious adverse events were determined to be related to ExoFlo. No infusion reactions were observed, supporting the favorable safety profile of this investigational product. The overall 60-day mortality rate was lower in patients younger than 65 years old compared with those 65-85 years old (22% and 42%, respectively). Further, patients younger than 65 were discharged from the hospital earlier and had more ventilator-free days than patients 65-85.

“It is exciting to see the safety results in over 100 patients who typically were too sick to enroll in our Phase 2 or Phase 3 randomized control trials. I am encouraged by the potential ExoFlo holds as we eagerly await the results from our ongoing Phase 3 trial and look forward to the potential to save more lives afflicted with ARDS,” said Amy Lightner, M.D., Chief Medical Officer of Direct Biologics.

Phase 3 EXTINGUISH ARDS trial

The global multicenter randomized, double-blinded, placebo-controlled pivotal Phase 3 EXTINGUISH ARDS trial (NCT05354141) is designed to evaluate the safety and efficacy of ExoFlo for the treatment of hospitalized patients with moderate-to-severe ARDS from any underlying etiology. The trial is expected to enroll 320 patients ages 18-65. The trial will have two treatment arms with half of the enrolled patients receiving a placebo and half receiving up to three intravenous doses of ExoFlo-15 mL. All patients in both arms will receive standard of care.

The primary endpoint of 60-day all-cause mortality was selected based on the significant survival benefit observed in the completed randomized Phase 2 clinical trial of ExoFlo. Secondary endpoints include ventilator-free days, oxygen-free days and ICU-free days, along with additional exploratory endpoints. In addition, the trial will evaluate the efficacy of ExoFlo in ARDS subtypes to better understand the disease process. In March 2022, ExoFlo received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for the treatment of severe or critical COVID-19, which provides opportunities to expedite ExoFlo’s clinical development for moderate-to-severe ARDS.

About Direct Biologics

Direct Biologics is a late-stage biotechnology company leveraging a regenerative medicine platform which uses extracellular vesicles (EVs) secreted from mesenchymal stem cells to address multiple disease indications. Direct Biologics’ mission is to be the global leader in regenerative medicine through discovery, innovation, advancement of science, and treatment of patients in a safe and effective manner. Our therapeutic product candidate, ExoFlo, is designed to be a scalable, reproducible, and effective next-generation biologic that leverages our proprietary EV platform technology designed to reduce inflammation, modulate the immune system, and restore tissue through cellular regeneration. Direct Biologics is currently conducting the global Phase 3 EXTINGUISH ARDS clinical trial of ExoFlo for the treatment of hospitalized adults with moderate-to-severe acute respiratory distress syndrome (ARDS). In addition, the Company has initiated Phase 1 clinical trials with ExoFlo for the treatment of ulcerative colitis and Crohn’s disease, and expanded access trials in solid abdominal organ transplantation and severe ARDS patients. Direct Biologics intends to pursue additional clinical applications including perianal fistulizing Crohn’s disease and necrotizing enterocolitis. Headquartered in Austin, Texas, Direct Biologics also has an R&D facility at the Center for Novel Therapeutics on the campus of University of California at San Diego, and operations and order-fulfillment center in San Antonio, Texas. For more information, please visit www.directbiologics.com and follow us on Twitter @directbiologics.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230419005585/en/