Date: 2014-02-17
Type of information:
phase: 2a
Announcement: completion of patient recruitment
Company: Galapagos (Belgium)
Product: GLPG0974
Action
mechanism: GLPG0974 is an orally available small molecule that reduces migration of neutrophils, one of the critical cell types in inflammatory processes, by potent inhibition of FFA2 (free fatty acid receptor 2, formerly known as GPR43). Over-activity of neutrophils is a cause of tissue damage in illnesses such as inflammatory bowel disease. A reduction of neutrophil activation and migration by inhibition of FFA2 may provide for a novel anti-inflammatory treatment approach. By inhibiting FFA2, GLPG0974 prevents free fatty acid-induced activation and migration of neutrophils towards an inflammatory site, such as in the gut of patients with inflammatory bowel disease. GLPG0974 is the first inhibitor of FFA2 to be evaluated clinically. Galapagos expects to report results of the Proof of Concept in June 2014.
Disease: ulcerative colitis
Therapeutic area: Autoimmune diseases - Inflammatory diseases
Country: Belgium, Latvia, Czech Republic and Slovakia
Trial details: 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.
Latest
news: * On February 17, 2014, Galapagos has announced that patient recruitment has been completed for the clinical Proof of Concept study with GLPG0974. The efficacy and safety of GLPG0974 are being evaluated during a 28-day treatment period. Topline results from this study are expected in June 2014. GLPG0974 is fully proprietary to Galapagos.
* On April 23, 2013 Galapagos has announced the start of the first Phase 2 clinical study with GLPG0974. 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.
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.
The trial is anticipated to complete by year end and deliver top line data by Q1 2014.
