STAB - Statera Bio submits Phase 3 trial protocol to FDA for pediatric Crohn's disease

Statera Biopharma (NASDAQ:STAB) soars 10.2% premarket after submitting its Phase 3 clinical trial protocol for STAT-201 in the treatment of pediatric Crohn’s Disease (CD) to the FDA. The Phase 3 trial 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. Recently, FDA lifted clinical hold on STAB's Entolimod research and development activity in acute radiation syndrome.

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Statera Bio submits Phase 3 trial protocol to FDA for pediatric Crohn’s disease