Belgium-based clinical stage biotech firm Galapagos has completed patient enrolment in a clinical proof-of-concept Phase II trial of GLPG0974 for the treatment of ulcerative colitis, a debilitating inflammatory bowel disease.
A total of 45 patients with mild to moderate ulcerative colitis have been enrolled in the trial, which is designed to evaluate the safety, efficacy, pharmacokinetics and effects on selected biomarkers of GLPG0974 in this patient population.
In the trial, patients are randomised to receive either 200mg of GLPG0974 twice-daily or placebo (2:1 ratio), for a period of 28 days.
The double-blind, placebo-controlled trial enrolled patients in multiple sites in four countries, including Belgium, the Czech Republic, Latvia, and Slovakia, and the topline results are expected to be released in June 2014.
GLPG0974 is a potent inhibitor of FFA2 (free fatty acid receptor 2) and is aimed at reducing migration of neutrophils into the gastro-intestinal tract as over-activity of neutrophils damages the bowel tissue and causes chronic inflammation in ulcerative colitis.
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The company said that FFA2 plays a key role in the migration of neutrophils and is over-expressed in ulcerative colitis patients.
Reduction of neutrophil activation and migration by inhibition of FFA2 is expected to provide a new anti-inflammatory treatment approach.
In healthy volunteers, 14 days of once or twice-daily oral dosing of GLPG0974 was well-tolerated and safe up to the highest doses tested and a sustained suppression of a biomarker for neutrophil activation showed the desired pharmacodynamic activity.
Bacteria produce free fatty acids by fermentation of food fibers in the gut, which attract neutrophils through the activation of the neutrophil FFA2 receptor.
AbbVie and Galapagos have signed a worldwide licensing agreement in the field of inflammation, which will involve AbbVie taking responsiblity for further development and commercialisation of GLPG0634 after Phase IIb.
Galapagos specialises in new modes-of-action, with a large pipeline including six Phase II studies (three led by GSK), one Phase I study, six pre-clinical, and 20 discovery small-molecule and antibody programs in cystic fibrosis, inflammation, antibiotics, metabolic disease, and other indications.
Image: Histopathological image of the active stage of ulcerative colitis. Photo: courtesy of KGH.
