Galapagos has started dosing of 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. Also, the company has announced the opening of an Investigational New Drug (IND) file with the US Food & Drug Administration for GLPG2222, triggering a $10 million milestone payment.
The company explained that 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.
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.
Dr. Piet Wigerinck, Chief Scientific Officer of Galapagos said: “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 copmany has triggered a $10 million milestone payment from AbbVie by opening of the IND with the FDA. The opening forms the basis for Galapagos and AbbVie to perform future studies with GLPG2222 in the US.