Galapagos NV has dosed the first patient with cystic fibrosis (CF) Class III (F508del and a gating mutation like G551D) with novel CF corrector GLPG2222 as an add-on to Kalydeco in a Phase 2a study.
In addition, Galapagos has opened an Investigational New Drug (IND) file with the US Food & Drug Administration for GLPG2222.
The ALBATROSS Phase 2a study is a multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate two doses of orally administered GLPG2222 in adult subjects with a diagnosis of CF harboring one F508del CFTR mutation and one gating mutation.
Up to 35 evaluable subjects are planned to be included in the study. Eligible subjects must be on stable treatment with physician prescribed Kalydeco for at least 28 days at the baseline visit. They will receive one of two active doses of GLPG2222 or placebo administered for 29 days.
The primary objective of ALBATROSS is to evaluate safety and tolerability of GLPG2222 in patients. Secondary objectives will include the assessment of ppFEV1, changes of sweat chloride, and CFQ- R. Topline results are expected in Q4 2017.
“The aim of the ALBATROSS study is to enhance our understanding of GLPG2222 in a CF patient population,” said Dr. Piet Wigerinck, Chief Scientific Officer of Galapagos. “With ALBATROSS we expect to learn more about our dosing modelling for the triple combination therapy; patients who participate may potentially help other CF patients still in need of a life-changing therapy.”
The opening of the IND with the FDA forms the basis for Galapagos and AbbVie to perform future studies with GLPG2222 in the US, and triggers a $10 million milestone payment from AbbVie to Galapagos.