Galapagos NV announces dosing of the first psoriasis patient in the Phase 1b trial with GLPG3667.
GLPG3667 is a proprietary compound with an undisclosed mechanism of action in development for inflammatory and autoimmune indications. Based on an initial clinical study in healthy volunteers, GLPG3667 has met the criteria to be further studied in patients.
This Phase 1b trial is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of GLPG3667. A daily oral administration of GLPG3667 at two different dose levels or a placebo will be investigated for 4 weeks in 30 patients with moderate to severe plaque psoriasis. The primary endpoint will be the change from baseline in Psoriasis Area Severity Index (PASI) score at 4 weeks. The first patient was dosed today. Recruitment will be based in Europe.
Pending successful completion of the Phase 1b study in psoriasis, we anticipate evaluating GLPG3667 in dose range finding Phase 2 studies in psoriatic arthritis and ulcerative colitis in the second half of 2021.
“We continue to press forward with several mechanisms of action in inflammation as part of our strategy to bring improved therapies to patients. We look forward to applying our extensive clinical experience in inflammation to this additional approach with GLPG3667. The study in psoriasis and the biomarker information collected should pave the way for trials in psoriatic arthritis and other indications,” said Dr. Piet Wigerinck, Chief Scientific Officer of Galapagos.
GLPG3667 is an investigational drug and not approved by any regulatory authority. Its efficacy and safety have not been established.