Pharmaceutical Business review

Galapagos GLPG0778 meets clinical Proof-of-Mechanism milestone with GSK

The Phase I study of GLPG0778 is a part of an immuno-inflammatory alliance with GSK, and involved 45 healthy volunteers, who were divided into 5 cohorts, receiving in total 4 different dosages of GPLG0778 for 2 weeks.

The results showed that GLPG0778 demonstrated dose-dependent, statistically-significant and selective suppression of an induced inflammatory response.

The study measured the biomarker response, as well as provided information on the safety, tolerability and Pharmacokinetic (PK) profile of GLPG0778.

GSK will evaluate the results and determine whether to exercise its exclusive option to in-license GLPG0778 and its corresponding back-up compounds, including GLPG0555.

Galapagos CEO Onno van de Stolpe said GLPG0778 is the company’s second drug candidate to show targeted activity in clinical trials.

"We believe GLPG0778’s biomarker and safety profile support its further development in a Phase II clinical study in a patient population," Stolpe added.