Galapagos has commenced a Phase IIa study of GLPG0974, which is designed to provide a novel mode of action for the treatment of ulcerative colitis.
The four-week study will test the efficacy and safety of GLPG0974, and is expected to deliver results in 2014.
Galapagos CSO Dr Piet Wigerinck said GLPG0974 was developed as a drug to inhibit FFA2, which plays a vital role in inflammatory diseases.
"GLPG0974 is the first FFA2 antagonist being evaluated clinically, and we are looking forward to the results in ulcerative colitis patients. If the drug shows efficacy in these patients, this will be an important step, as there is currently no cure for this disease. We expect to report the results of the study in early 2014," Wigerinck said.
A total of 45 patients with mild to moderate ulcerative colitis will participate in the clinical proof-of-concept Phase II trial for GLPG0974.
GLPG0974's efficacy, effects on selected biomarkers, safety and tolerability and pharmacokinetics will be assessed in the double-blind, placebo-controlled study.
Patients will be randomised in a 2:1 ratio with either 200mg of GLPG0974 twice a day or placebo for a period of four weeks.
Patient recruitment will be carried out in multiple sites across four countries, including Belgium, Latvia, Czech Republic and Slovakia.
A Phase I GLPG0974 study demonstrated positive results, leadining to the initiation of the Phase II proof-of-concept study.
In the previous study, sustained suppression of biomarkers for neutrophil activation demonstrated the desired pharmacodynamic activity, and two weeks of once or twice-daily oral dosing in healthy volunteers was well-tolerated and safe up to the highest doses tested.
Image: Histopathological image of the active stage of ulcerative colitis. Photo: Courtesy of KGH.