A Phase I clinical trial has begun evaluating Direct Biologics’ ExoFlo for the treatment of patients with medically refractory ulcerative colitis (UC).
Direct Biologics uses extracellular vesicles (EVs) derived from bone marrow mesenchymal stem cells (MSCs) to address multiple disease indications.
The trial is expected to enrol 10 patients, aged 18-75 years, who have had a diagnosis of medically refractory UC of at least six months duration and have failed at least one monoclonal antibody therapy.
These patients will be randomised to treatment with intravenous ExoFlo every month or every other month over the course of one year.
“The initiation of our ulcerative colitis clinical study is an important milestone as it marks the beginning of Direct Biologics’ clinical trial programme for inflammatory bowel disease, a chronic condition with no known cure,” said Amy Lightner, Chief Medical Officer of Direct Biologics.
“ExoFlo’s safety profile, combined with its anti-inflammatory, immunomodulatory and regenerative properties, make it an ideal next generation candidate for ulcerative colitis. This has the potential to fulfil a critical, unmet need for the thousands of patients suffering from this chronic condition.”
The primary objective of the trial is to evaluate the safety of intravenous ExoFlo. The secondary objective is to evaluate the efficacy of intravenous ExoFlo in inducing clinical remission, clinical response, and improvement in patient reported outcomes. This is measured by changes in laboratory values including C-reactive protein and faecal calprotectin, and changes in validated clinical and endoscopic scoring systems.