Belgium-based Galapagos NV has announced it is discontinuing its clinical development of drug candidate GLPG1205 for ulcerative colitis because an important part of the clinical trial — endpoints for efficacy — were not met.
The ORIGIN Phase 2a clinical trial with GLPG1205 in patients with ulcerative colitis received good feedback on pharmacokinetics, tolerability, and safety, the company reported in a press release. But the important efficacy endpoints of the trial were not met, leading Galapagos to discontinue clinical development.
The company said it will decide whether to develop the drug in alternative medical indications, and that more details about the ORIGIN study will be released later this year.
Ulcerative colitis is a chronic, gastrointestinal disorder involving the rectum and the colon — the large bowel — mainly in the mucosa and sub-mucosa gut regions where ulcerations occur. The symptoms can start mild and gradually progress to more severe, with remission periods in between.
One of the most commonly reported symptoms is progressive loosening of stool with blood, accompanied by abdominal pain and occasional fever. Loss of appetite, weight loss, and fatigue are not uncommon.
Last June, Galapagos announced its Phase 2 proof-of-concept study to evaluate GLPG1205, a GPR84 inhibitor, as a possible therapy for inflammatory bowel diseases (IBD). The GPR84 is a G-coupled protein receptor — a free fatty acid protein that plays a crucial role in the regulation of neutrophils, monocytes, and macrophages in the immune system. GPR84 is highly implicated in the inflammation process.
The company previously showed through in vitro models that when GPR84 is inhibited it prevents macrophage and neutrophil chemotaxis, and that, in living patient models, GLPG1205 was able to prevent IBD progression.
The ORIGIN Phase 2a study was a randomized, double-blind clinical trial designed to determine the drug’s pharmacokinetics, safety, and tolerability, as well as efficacy. The study’s purpose was also to understand the drug’s effects on selected biomarkers in patients with ulcerative colitis. For 12 weeks, study participants were administered either GLPG1205 100 mg per day or a placebo.
The ORIGIN results revealed that GLPG1205 was overall safe and well-tolerated by patients, in agreement with data from healthy volunteers in the Phase 1 clinical study.
However, researchers found no statistically significant differences between GLPG1205 treatment and the placebo on (partial) Mayo scores.
Galapagos NV, headquartered in Mechelen, Belgium, is a clinical-stage biotechnology company whose pipeline includes clinical and pre-clinical trials and discovery studies to treat conditions such as osteoarthritis, inflammation, and cystic fibrosis.