Pharm-Olam is now enrolling patients in the U.S. and Europe into a pivotal Phase III study within the treatment of short bowel syndrome (SBS).
“Zealand Pharma has been an excellent study sponsor to work with, and this study combines our teams’ talents in orphan and gastrointestinal diseases,” said Yamin Khan, Ph.D., executive vice president, clinical development, at Pharm-Olam. “As a leader in orphan research with over 100 studies, we look forward to completing enrollment and successfully delivering this critical program for Zealand.”
Initiated in early October 2018, the study is a placebo-controlled, randomized, parallel-group, double-blind clinical trial with fixed-dose injections. The trial is being conducted at approximately 40 investigational sites in the United States, Canada, and Europe and will ultimately enroll 129 patients with SBS.
Because people with SBS often cannot absorb enough nutrients, the trial will help determine if parenteral support volume can be reduced. Zealand Pharma is developing a long-acting GLP-2 analog in an auto-injector with potential for convenient weekly administration, which has been granted orphan status by the U.S. Food and Drug Administration.
“We congratulate Zealand Pharma on initiating this important study and together, we have enrolled patients in a number of countries already,” said Khan. “We are hopeful that the results from this study will lead to better and much-needed treatment options for people with SBS.”