Date: 2017-03-22
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Galapagos (Belgium) AbbVie (USA - IL)
Product: GLPG3067
Action mechanism:
Disease: cystic fibrosis
Therapeutic area: Rare diseases - Genetic diseases
Country: Belgium
Trial details: The study is a First-in-Human, Phase I, randomized, double-blind, placebo-controlled, single center study, evaluating single and multiple ascending oral doses of GLPG3067 and the combination of GLPG3067 and GLPG2222 given for 14 days in healthy women of non-childbearing potential. The purpose of the study is to evaluate the safety and tolerability of single ascending oral doses and multiple ascending oral doses of GLPG3067 given to healthy women of non-childbearing potential compared to placebo, as well as of multiple oral doses of the combination of GLPG3067/GLPG2222 compared to GLPG3067/placebo. (NCT03128606)
Latest news: • On March 22, 2017, Galapagos announced initiation of a Phase 1 study with novel potentiator GLPG3067 for cystic fibrosis in a Phase 1 study.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.
