Our TYK2 program with GLPG3667
GLPG3667 is a reversible and selective TYK2 kinase domain inhibitor discovered by us. In 2020, we tested the molecule in a healthy volunteer study. This Phase 1 study was a randomized, double-blind, placebo-controlled dose escalation study evaluating safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending oral doses for 13 days. Blood was drawn at multiple time points on Day 1 and on Day 10 and stimulated ex vivo with several cytokines, including IFNα and IL-6, to analyze the level of inhibition in pSTAT signaling obtained by GLPG3667. The Phase 1 data showed an encouraging PK profile for once-daily dosing and PD activity:
In November 2020, we announced the first dosing in the Phase 1b trial with GLPG3667 in psoriasis patients. This Phase 1b trial is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of GLPG3667. A daily oral administration of GLPG3667 at two different dose levels or a placebo is being investigated for a duration of 4 weeks in 30 patients with moderate to severe plaque psoriasis. The primary endpoint is the change from baseline in Psoriasis Area Severity Index (PASI) score at 4 weeks. Recruitment is based in Europe and topline data are expected in 2021.
Pending successful completion of the Phase 1b study in psoriasis, we anticipate the evaluation of GLPG3667 in dose range finding Phase 2 studies in psoriatic arthritis and other indications, potentially starting before year end 2021.