Statera Biopharma, Inc. (NASDAQ:STAB), a leading biopharmaceutical company creating next-generation immune therapies that focus on immune restoration and homeostasis, today announced submission to the U.S. Food and Drug Administration (FDA) of its Phase 3 clinical trial protocol for STAT-201 in the treatment of pediatric Crohn's Disease (CD).
"Submitting our Phase 3 clinical trial protocol is a critical milestone in our development program," said Michael K. Handley, President and Chief Executive Officer, Statera Biopharma. "In addition to the common GI symptoms, children with Crohn's Disease often experience growth failure, malnutrition, delayed puberty, and bone demineralization. STAT-201 has the potential to provide great physical and emotional relief to adolescents who live with Crohn's Disease."
The Phase 3, multicenter, randomized clinical trial, A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety, of STAT-201 in Pediatric Patients Aged 12 to 17 Years (Inclusive) with Active Crohn's Disease, will evaluate the safety and efficacy of STAT-201 compared to placebo in establishing remission in pediatric CD patients. The trial sites are currently being selected and enrollment is expected to launch in early 2022.
CD is a chronic relapsing inflammatory condition of the gastrointestinal (digestive) tract, causing symptoms such as persistent diarrhea, abdominal pain, and rectal bleeding. Once considered rare in the pediatric population, it is currently recognized as one of the most important chronic diseases that affect children and adolescents. Approximately 20-30% of all patients with CD present when they are younger than 20 years of age. The signs and symptoms are unpredictable, resulting in physical, emotional, and economic burdens. CD continues to impose significant burdens on patients, despite current treatments, patients continue to have disease flares, smoldering disease, or experience intolerable side effects and new treatment options are needed. 1
STAT-201, Statera's most advanced drug candidate, is an immune modulator focused on the restoration of mucosal healing and intestinal barrier function as an adjunct to the standard of care in moderate to severe CD. A Phase 2 study demonstrated proof of concept and safety as well as remission in 67% of participants and 43% of true mucosal healing with endoscopies. No serious adverse events were reported in the trial. STAT-201 also has received FDA orphan drug designation for the treatment of CD in pediatric patients.