Date: 2011-12-19
Type of information:
phase: 1
Announcement: results
Company: Galapagos (Belgium) GSK (UK)
Product: GLPG0778
Action mechanism:
Disease:
Therapeutic area: Inflammatory diseases
Country:
Trial
details: Galapagos plans to conduct the multiple ascending dose study in 45 healthy volunteers using five two-week dosing regimens. In this Proof of Mechanism study, GPLG0778's ability to suppress an induced inflammatory response in healthy volunteers will be evaluated. In addition to measuring the biomarker response, the safety, tolerability and pharmacokinetics of candidate drug GLPG0778 will be assessed further. Galapagos aims to report the study results in the fourth quarter of 2011. GSK has an exclusive option to in-license this compound.
Latest
news: * On December 19, 2011, Galapagos has announced that investigational medicine GLPG0778, which is part of its immuno-inflammatory alliance with GSK, has shown selective effects on a biomarker in a Phase I Proof-of-Mechanism study in healthy volunteers. The study also provided information on the safety and pharmacokinetic profile of GLPG0778. Galapagos conducted the Phase I study in 45 healthy volunteers divided into 5 cohorts, receiving in total 4 different dosages for 2 weeks. GPLG0778 showed dose-dependent, statistically-significant and selective suppression of an induced inflammatory response in the volunteers, indicating specific inhibition of the medicine's target in vivo. In addition to measuring the biomarker response, the study also provided information on the safety, tolerability and PK of GLPG0778. GSK has determined that these results meet the criteria of clinical Proof of Mechanism, thereby triggering a € single-digit millions payment to Galapagos. GSK now has 90 days to evaluate these results and determine whether to exercise its exclusive option to in-license GLPG0778 and its corresponding back-up compounds, including GLPG0555. Galapagos and GSK initiated an alliance to discover and develop disease-modifying drugs for GSK's global R&D organization in June 2006. Subject to achievement of certain milestone events Galapagos has the potential to receive more than €200 million in total milestone payments, plus up to double-digit royalties from GSK. GSK has an exclusive option to further develop and commercialize compounds from the alliance on a worldwide basis. Since the start of the immuno-inflammation alliance, Galapagos has received more than €64 million in payments from GSK.
* On May 11, 2011, Galapagos has initiated a second Phase I Proof of Mechanism study in its immuno-inflammation alliance initiated with GSK in June 2006. This new study follows the positive outcome of the first-in-human trial conducted for GLPG0778, which showed an acceptable safety and pharmacokinetics profile in healthy volunteers for one-week dosing and an initial biomarker response. The Proof of Mechanism study is aimed at assessing GLPG0778's effect on a specific target in healthy volunteers.
