Zealand Pharma A/S (Zealand) recently announced in a press release the start phase 3 trial for short bowel syndrome treatment. The trial investigates the use of glepaglutide as a treatment for short bowel syndrome, and the first patient has already been enrolled. The goal of the trial is demonstrate both that glepaglutide is effective and safe for patient use. Keep reading to learn more, or follow the original story here for more information.
What is Short Bowel Syndrome?
Short bowel syndrome, also known as SBS, is a rare condition in which part of the small intestine is missing. This may be a result of disease, injury, surgery, or birth defect. As a result, individuals with short bowel syndrome are unable to absorb the proper amount of nutrients from food and water.
Symptoms of SBS may vary in form and severity. The most common difficulty for people living with short bowel syndrome is persistent diarrhea. Other symptoms may include bloating, cramping, fatigue, heartburn, dehydration, and vomiting. SBS may also lead to other medical complication such as anemia, kidney stones, and fatty liver.
The United States Food and Drug Administration granted glepaglutide orphan drug designation for the treatment of SBS. Professor Palle Bekker Jeppesen, MD, PhD, is the principal investigator for the phase 3 trial. She acknowledges that the phase 2 trial bore impressive results, and expresses excitement for the upcoming tests. Glepaglutide is, as she describes it, a promising new candidate for a group of people in need of better options. Executives at Zealand describe the drug as “potentially life-changing.”
The phase 3 trial for glepaglutide aims to determine the efficacy and safety of the drug in once-weekly, and twice-weekly doses. Researchers plan to enroll 129 patients into the study. Locations for the trial exist in 40 sites spread across the United States, Canada, and Europe. Patients receiving treatment will be compared to a placebo group to determine the drug’s effects. The study will also be conducted using randomized, parallel-group, double-blind procedures. While safety is a major concern, the study’s primary goal is to determine how effect glepaglutide is at decreasing a patient’s need for parenteral support.