Direct Biologics Announces Initiation of Phase 1 Clinical Trial for Medically Refractory Crohn’s Disease

First patient dosed with ExoFlo^™ in open-label trial

AUSTIN, Texas--(BUSINESS WIRE)--Direct Biologics, LLC, a late-stage biotechnology company leveraging its regenerative medicine platform using extracellular vesicles (EVs) derived from bone marrow mesenchymal stem cells (MSCs) to address multiple disease indications, announced it has dosed the first patient in its Phase 1 clinical trial evaluating ExoFlo^™ for the treatment of patients with medically refractory Crohn’s disease.

“We are excited to announce the initiation of our Crohn’s disease clinical trial as we expand our ExoFlo clinical development program into inflammatory bowel disease,” said Amy Lightner, M.D., Chief Medical Officer of Direct Biologics. “Crohn’s disease is a debilitating lifelong condition that affects every aspect of daily life. With this new trial of ExoFlo, we are seeking to further illustrate the potential anti-inflammatory, immunomodulatory and regenerative properties of ExoFlo, each of which we believe to be crucial in the treatment of Crohn’s disease.”

The open-label Phase 1 clinical trial (NCT05130983) is designed to evaluate the safety and efficacy of ExoFlo for the treatment of medically refractory Crohn’s disease. The trial is expected to enroll 10 patients between the ages of 18 and 75 who have been diagnosed with medically refractory moderate-to-severe Crohn’s disease of at least six months duration and have failed at least one monoclonal antibody therapy. The trial will randomize the 10 patients to two treatment arms. One arm will receive intravenous ExoFlo monthly, and the other arm will receive intravenous ExoFlo every other month.

The primary objective for this trial is to ensure safety in this patient population by recording any adverse or serious adverse events. The secondary objective is to evaluate the efficacy of intravenous ExoFlo in inducing clinical response, clinical and endoscopic remission, and improving disease-specific, health-related quality of life. The trial will measure changes in laboratory values including C-reactive protein and fecal calprotectin, validated clinical scores, validated endoscopic scores, and validated patient survey scores, among others.

About Crohn’s Disease

Crohn’s disease is an idiopathic chronic inflammatory disease of the intestinal tract, which continues to increase in incidence for unknown reasons, resulting in a significant burden to the healthcare system. Crohn’s disease is characterized by transmural inflammation of the intestinal wall which can result in inflammatory, fibrostenosing or penetrating disease of the intestinal tract. This results in patients experiencing chronic abdominal pain, flares resulting in hospitalization or change in medications, and risk of surgical intervention. Despite the ever-growing armamentarium of immunosuppressive medications available, up to 70% of patients still undergo an intestinal resection for medically refractory disease. This current treatment paradigm presents significant potential side effects from approved medications, morbidity with frequent hospitalizations, risk with recurrent intestinal operations, and significantly impaired quality of life in thousands of patients.

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 clinical trial of ExoFlo for the treatment of hospitalized adults with Acute Respiratory Distress Syndrome (ARDS) due to COVID-19. 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 COVID-19 ARDS patients. Direct Biologics intends to pursue additional clinical applications including all-cause ARDS, 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.