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Direct Biologics Announces FDA Authorization to Expand Ongoing Phase 3 Clinical Study of ExoFlo™ to All-Cause Moderate-to-Severe ARDS

Wednesday, April 05, 2023

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 that the U.S. Food and Drug Administration (FDA) has authorized the expansion of its pivotal Phase 3 EXTINGUISH ARDS trial to evaluate the safety and efficacy of ExoFlo™ in the treatment of moderate-to-severe acute respiratory distress syndrome (ARDS) from any underlying etiology.

“ARDS is a respiratory disease characterized by a rapid onset of inflammation and fluid in the lungs with unacceptably high mortality and unsustainable treatment costs,” said Mark Adams, Chief Executive Officer of Direct Biologics. “We look forward to the results of our Phase 3 study given the significant survival benefit observed in our Phase 2 trial and the absence of any FDA-approved biologic for the treatment of moderate-to-severe ARDS.”

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 all-cause moderate-to-severe ARDS. 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 15 mL of ExoFlo. 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, or RMAT, designation by the FDA, which provides opportunities to expedite ExoFlo’s clinical development for ARDS.

“FDA authorization to expand our ongoing Phase 3 clinical trial to all-cause ARDS marks a defining moment for regenerative medicine. ExoFlo, designed to repair lung tissue while being a potent anti-inflammatory and immunomodulatory agent, is the first cell or cell-derived therapeutic candidate to be evaluated in a Phase 3 trial for all-cause moderate-to-severe ARDS. In fact, ExoFlo is one of a small handful of biologics that has demonstrated adequate tolerability and clinical activity to gain allowance by the FDA for Phase 3 evaluation in moderate-to-severe ARDS,” said Amy Lightner, M.D., Chief Medical Officer of Direct Biologics.



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