The eight-week clinical trial compared three doses of teduglutide delivered by daily subcutaneous injection to a placebo. The study was designed to evaluate the drug’s safety and potential efficacy in the treatment of Crohn’s disease.
Overall, the study results showed a consistent trend toward efficacy and a dose response favoring the highest dose group: 36.8% of patients receiving the highest dose of teduglutide reached clinical remission at week two versus 16.7% of the placebo group, while 55.6% of patients in the highest dose group reached clinical remission by week eight compared to 33.3% of the placebo group.
Teduglutide was well tolerated with no serious adverse events related to the drug. The most common treatment-related adverse event in the trial was redness at the injection site.
“Remission rates of this magnitude at two weeks and eight weeks are unusual in clinical trials and suggest that teduglutide may play an important role in the management of this difficult-to-treat disease,” said Dr Alan Buchman, a clinical investigator for the study and associate professor and director of the IBD Center at Northwestern University’s Feinberg School of Medicine.
Crohn’s disease is a chronic inflammatory bowel disease characterized by inflammation of any part of the gastrointestinal tract and associated with chronic morbidity.