Stero Biotechs received its second Helsinki approval to move forward with a second Phase 2a clinical trial. The trial will be a randomized, double-blind, placebo-controlled, multicenter study of ST-SDCD-01, a CBD based solution in an effort to lower the steroid dosage in patients with Steroid Dependent Crohn's Disease (SDCD).
The purpose of the study will be to evaluate the tolerability, safety, and efficacy of the formulation as a steroid-sparing therapy in SDCD patients. Up to 30 participants with SDCD will be included in the study with a 2:1 CBD: placebo treatment ratio.
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Crohn's disease is an incurable form of Irritable Bowel Disease that can cause severe chronic symptoms that are most often treated with immunosuppressant and steroid medications. Chronic use of such medications are associated with a number of serious side effects including bone loss/fractures, weight gain, hypertension, mood disturbances, cataracts, glaucoma, diabetes, increased risk of infection, and more.
CBD was shown to have immunosuppressive and anti-inflammatory effects and may provide a path to reducing steroid treatment dose and duration for SDCD patients.
The study is set to begin on July 2019, and will be run by Dr. Timna Naftali, a specialist in gastroenterology at Meir Hospital in Kfar Saba, and conducted over 12 months across four Israeli medical facilities including Meir Hospital, Soroka University Hospital in Be'er Sheva, HaEmek Hospital in Afula, and Clalit's Talpiot Clinic in Jerusalem.