SDCD is a form of Crohn’s disease, which is a type of inflammatory bowel disease (IBD), that can be controlled only with continuous use of steroid-based medications.
Such medications, while effective, can cause a host of unpleasant side effects, especially when used regularly for an extended time. These side effects can include bone weakness (which can lead to breaks and fractures), diabetes, infections, high blood pressure, weight gain, mental health disturbances, and more.
That is why there is a need for additional treatments that can lower the amount of steroids people with SDCD need to take; these are called “steroid-sparing” treatments.
The randomized, double-blind, placebo-controlled, Phase 2a clinical trial will be evaluating the safety, tolerability, and efficacy of one potential steroid-sparing treatment, Stero’s ST-SDCD-01.
The product was described in a press release as a “CBD-based solution.” CBD is a chemical that can be derived from the cannabis plant and is being investigated for a range of potential health applications, including relieving anxiety and reducing inflammation and immune system activity. Although it is naturally found in cannabis, CBD is not psychoactive (meaning it won’t make anyone “high”).
A previous, small study investigating a cannabis oil (containing, among other active ingredients, 15% CBD) found that the oil significantly reduced symptoms and improved quality of life, but did not reduce endoscopic scores or inflammation, in people with Crohn’s disease.
In the trial, which is supposed to begin this month and last up to a year, 30 people with SDCD will be randomized 2:1 (two-thirds in one group and one third in the other) to receive either ST-SDCD-01 or a placebo. The trial will be conducted at four Israeli medical facilities (Meir Hospital in Kfar Saba, Soroka University Hospital in Be’er Sheva, HaEmek Hospital in Afula, and Clalit’s Talpiot Clinic).
The trial will be led by Timna Naftali, MD, who is a specialist in gastroenterology (the branch of medicine that deals with the digestive system) at Meir Hospital. Stero Biotechs owns a patent for the use of CBD as a steroid-sparing treatment in more than 130 inflammatory and autoimmune diseases.