Galapagos Initiates Phase 2 Trial With GLPG1205 In Ulcerative Colitis Patients

By RTT News, January 08, 2015, 01:43:00 AM EDT

(RTTNews.com) - Galapagos NV (GLPGF.PK, GLPYY.PK), a Belgium-based clinical stage biotech company, announced Thursday that it has initiated a Phase 2 Proof-of-Concept study in ulcerative colitis with GPR84 inhibitor GLPG1205, a potential novel treatment for Inflammatory Bowel Diseases.

GLPG1205 arises from Galapagos' target discovery platform and is fully proprietary to the company.

The firm noted that GLPG1205 ('1205) inhibits GPR84, a novel mechanism of action developed by Galapagos for Inflammatory Bowel Diseases or IBD. Galapagos has shown that GPR84 plays a key role in IBD and that '1205 is a selective inhibitor of GPR84 and very effective in pre-clinical models for IBD.

In Phase 1 studies, '1205 showed good safety, full blockage of GPR84, and favorable drug-like properties. The first patients in this double-blind, placebo controlled study will initiate their treatment this week.

Galapagos said the clinical Proof-of-Concept Phase 2 trial for '1205 will involve approximately 60 patients with moderate to severe ulcerative colitis. The aim is to evaluate the efficacy, safety and tolerability and pharmacokinetics of '1205, and to explore the effects of '1205 on selected biomarkers in this patient population.

Galapagos has received full approvals to start the trial in Belgium, Hungary, Germany and the Czech Republic, with patient recruitment already underway. Approvals in Russia and Poland are expected to follow this first quarter. The trial is anticipated to deliver top line data in first half of 2016.

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Galapagos Initiates Phase 2 Trial With GLPG1205 In Ulcerative Colitis Patients