Galapagos initiates Phase 1 study with novel CF potentiator GLPG3067

• Triggers a $7.5 M milestone payment from AbbVie
• Third potentiator in growing portfolio of cystic fibrosis drug candidates

Mechelen, Belgium; 22 March 2017, 7.30 CET -Galapagos NV (Euronext & NASDAQ: GLPG) announces initiation of a Phase 1 study with novel potentiator GLPG3067 for cystic fibrosis (CF) in a Phase 1 study. Galapagos is to receive a $7.5 million milestone payment from its collaboration partner AbbVie for this achievement.

The aim of the Phase 1 study is to evaluate the safety, tolerability and pharmacokinetics of oral single and multiple ascending doses of GLPG0367. The safety and tolerability of the combination of GLPG3067 and GLPG2222 will also be evaluated. The randomized, double-blind, placebo controlled, single centre study is being conducted in at least 48 healthy volunteers in Belgium. In the first part of the study, single ascending doses of GLPG3067 will be evaluated. In the second part, multiple ascending doses will be administered daily for 14 days. In the last part of the study the combination of GLPG3067 and GLPG2222 will be administered for 14 days. Topline results from this Phase 1 study are expected to be disclosed at a future medical conference.

In order to bring a more effective therapy to the majority of cystic fibrosis patients, Galapagos and AbbVie have a portfolio of candidates addressing three complementary components for a potential combination therapy. Galapagos is currently testing potentiator GLPG2451 and corrector GLPG2222 in healthy volunteers. The aim is to add corrector GLPG2737 to make a triple combination, which will first be evaluated in healthy volunteers and then in patients with the F508del mutation.

Triple combinations of CF compounds in the portfolio have consistently shown restoration of healthy activity levels in in vitro assays with human bronchial epithelial (HBE) cells of patients with the F508del mutation. These combinations result in an increase in chloride transport compared to Orkambi^[1] in HBE cells with the homozygous F508del mutation. 

"We continue to explore additional molecules to enrich our growing portfolio of cystic fibrosis drug candidates," said Dr Piet Wigerinck, CSO of Galapagos. "We plan to initiate multiple studies within our CF portfolio in the course of this year, as we get closer to our goal of initiating a patient evaluation of a triple combination therapy by mid-2017."