Galapagos NV has announced the start of the first Phase 2 clinical study with GLPG0974. This is the third compound from Galapagos' pipeline to enter Phase 2 studies, and its first drug for patients with gastro-intestinal inflammation.
GLPG0974 presents a novel mode of action for the treatment of ulcerative colitis, a debilitating inflammatory bowel disease.
The efficacy and safety of GLPG0974 will be tested in a four-week study with 45 patients and will deliver topline results early 2014.
As a potent inhibitor of FFA2, oral treatment with GLPG0974 aims to reduce migration of neutrophils into the gastro-intestinal tract. Excessive influx of this type of white blood cells damages the bowel tissue and causes chronic inflammation in ulcerative colitis.
The start of the Phase 2 Proof-of-Concept study follows the excellent Phase 1 results with GLPG0974. In healthy volunteers, 2 weeks of once- or twice daily oral dosing was well-tolerated and safe up to the highest doses tested.
A sustained suppression of biomarkers for neutrophil activation demonstrated the desired pharmacodynamic activity.
"We are very excited about the start of the Phase 2 study with GLPG0974. We discovered the role of the FFA2 target in inflammatory diseases, and we developed GLPG0974 as a drug to inhibit FFA2. With this clinical program, we expand our scope from rheumatology to gastroenterology," said Dr Piet Wigerinck, CSO of Galapagos.
Dr Wigerinck continued, "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."
Details of the Phase 2A clinical study
The clinical Proof-of-Concept Phase 2 trial for GLPG0974 will involve 45 patients with mild to moderate ulcerative colitis. The aim is to evaluate the efficacy, effects on selected biomarkers, safety and tolerability and pharmacokinetics of GLPG0974 in this patient population.
Patients with mild to moderate disease will receive either 200 mg of GLPG0974 twice-daily or placebo (2:1 ratio), for a period of four weeks.
This randomized, double-blind, placebo-controlled study will recruit patients in multiple sites in 4 countries: Belgium, Latvia, Czech Republic and Slovakia.
Galapagos has already received approvals to start the trial in Belgium, with patient recruitment starting this month. The trial is anticipated to complete by year end and deliver top line data by Q1 2014.