Galapagos NV recently announced that the company has completed recruitment of patients with ulcerative colitis for its phase 2 proof-of-concept study designed to evaluate GLPG1205 as a possible therapy for inflammatory bowel diseases (IBD). Galapagos is now ready to initiate the study and expects to release the first results of the clinical trial during the start of next year.
The study will examine the therapeutic potential of the GPR84 inhibitor in approximately 60 patients recruited in Belgium, Czech Republic, Germany, Hungary, Poland and Russia who suffer from moderate to severe ulcerative colitis
“We are pleased that recruitment for the ORIGIN study has gone so well, which means we can report topline results one quarter earlier than planned,” stated the Chief Scientific Officer of Galapagos, Dr. Piet Wigerinck, in a press release. “We look forward to finding out if this novel mode of action opens a new approach towards the treatment of ulcerative colitis patients.”
Galapagos announced in January its plans to initiate the phase 2 proof-of-concept study to evaluate the therapy. The randomized, double-blind clinical trial was designed to determine the therapy’s efficacy, safety, tolerability and pharmacokinetics, as well as to understand its effects on selected biomarkers in the ulcerative colitis patient population. The patients will be administrated either 100 mg of GLPG1205 or placebo once every day for twelve weeks.
The primary endpoint for the study will be alterations in Mayo scores compared to baseline at eight weeks, which will be confirmed with endoscopy to measure the improvement of the disease. Galapagos has identified GPR84 as a target for IBD through the company’s discovery platform and holds full propriety of GLPG1205, which features a novel mechanism of action that inhibits GPR84 and is expected to result in an effective treatment for patients with IBD.
GPR84 is unregulated in patients who suffer from IBD, and Galapagos has already demonstrated in previous pre-clinical models for IBD the effectiveness of GLPG1205 as a selective inhibitor of GPR84. Phase 1 studies, in which patients were treated once a day with the oral compound, revealed the safety profile of GLPG1205, as well as its ability to fully block GPR84 and its favorable drug-like properties.