Ongoing pivotal Phase 3 EXTINGUISH ARDS trial expands to enroll hospitalized patients with moderate-to-severe ARDS, regardless of underlying etiology

ExoFlo is the first cell or cell-derived therapeutic candidate to be evaluated in a Phase 3 trial for all-cause moderate-to-severe ARDS

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 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 ExoFlos 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.

About ARDS

Acute respiratory distress syndrome (ARDS) is a life-threatening condition characterized by acute and diffuse inflammatory lung injury resulting in increased fluid in the lungs, loss of ability to oxygenate and decreased lung compliance. Currently, 15% of all ICU patients and 23% of all ventilated patients in the United States are ARDS patients, which results in an annual intensive care expenditure exceeding $80 billion. The mortality rate of moderate-to-severe ARDS remains unacceptably high at 50%, despite improved ventilatory strategies such as protective ventilation and prone positioning. After decades of research, there is still no targeted or individualized therapy for the treatment of ARDS in the United States. The standard of care is still centered around optimizing mechanical ventilation and supportive care strategies without known mortality benefit.

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 Crohns 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 Crohns 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 http://www.directbiologics.com and follow us on Twitter @directbiologics.

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