Stero Biotechs to Commence Phase 2a Clinical Trial of Cannabidiol-Based Formulation for Patients With Crohn's Disease
TEL AVIV, Israel, July 23, 2019 /PRNewswire/ -- Stero Biotechs, an Israel-based, clinical-stage company focused on Cannabidiol (CBD) formulation research and development, 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.
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.
About Stero Biotechs, Ltd.
STERO Biotechs Ltd., founded in 2017 and headquartered in Israel, is a clinical-stage company committed to the research and development of novel Cannabidiol (CBD) based treatment solutions that will potentially benefit millions of patients by reducing the side effects and the need for steroid therapy. STERO was granted a U.S. patent on over 130 potential indications and is planning to commence more clinical trials in 2019 on various indications.
STERO has established an active partnership with one of its shareholders - MOR Research Applications, the tech transfer company of CLALIT HEALTH SERVICES. CLALIT is the is the second largest HMO in the world, with over 4.5 million members. CLALIT operates 14 full-scale hospitals specializing in all fields of medicine, as well as over 2000 community clinics with over 9000 physicians. The MOR-STERO partnership allows the company to reach vast numbers of patients and data, while collaborating with the physicians, labs and hospitals of Clalit.
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SOURCE Stero Biotechs