Mechelen, Belgium; 28 June 2018; 22.35 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) announces the topline results with investigational C2 corrector GLPG2737 in the first Phase 2 CF patient trial with this candidate and provides an update on its triple combo development strategy.
The PELICAN study was designed to evaluate the efficacy, safety and tolerability of a novel C2 corrector GLPG2737 in adult CF patients who are homozygous for the Class II F508del mutation. Participating patients were on stable treatment with Orkambi for at least 12 weeks prior to the first study drug administration and were required to continue Orkambi for the duration of the trial. Eligible patients were randomized to receive GLPG2737 (n=14) or placebo (n=8) over a period of 4 weeks, with up to 3 weeks’ follow up. The primary endpoint was the change from baseline in sweat chloride concentration compared to placebo at day 28. The PELICAN study was conducted in multiple sites in Germany.
GLPG2737 was well-tolerated by patients in this trial. All adverse events were mild to moderate, with no apparent difference compared to placebo. There were no deaths, no serious adverse events, and no premature discontinuations due to adverse events.
The mean change from baseline in sweat chloride for the GLPG2737 treatment arm on day 28 versus placebo was a significant decrease of 19.6 mmol/L (p=0.02). A positive trend in ppFEV1 changes was also observed. The mean absolute change from baseline in ppFEV1 for the GLPG2737 treatment arm versus placebo through day 28 was 3.4% (p=0.08). Further details will be presented at a future conference.
“The PELICAN trial is the first to evaluate GLPG2737 as a C2 corrector in CF patients on top of Orkambi and showed CFTR on-target activity with GLPG2737 in combination with Orkambi,” said Dr. Piet Wigerinck, Chief Scientific Officer of Galapagos. “We have initiated dosing in the FALCON trial, in which we aim to evaluate higher exposures of GLPG2737 in CF patients and further understand the potential synergistic effect of GLPG2737 on top of our own dual combination compounds.”
Update on triple combination therapy development plans
Galapagos is currently conducting FALCON, a clinical trial with an investigational triple combination therapy comprising potentiator GLPG2451, C1 corrector GLPG2222, and C2 corrector GLPG2737. The first interim data from this trial are expected in Q3 2018. AbbVie has decided not to proceed with the previously contemplated second triple combination therapy, consisting of the same C1 and C2 components combined with potentiator GLPG3067. Galapagos is reviewing the future of its CF collaboration with AbbVie.
Galapagos (Euronext & NASDAQ: GLPG) is a clinical-stage biotechnology company specialized in the discovery and development of small molecule medicines with novel modes of action. Galapagos’ pipeline comprises Phase 3 through to discovery programs in cystic fibrosis, inflammation, fibrosis, osteoarthritis and other indications. Our target discovery platform has delivered three novel mechanisms showing promising patient results in, respectively, inflammatory diseases, idiopathic pulmonary fibrosis and atopic dermatitis. Galapagos is focused on the development and commercialization of novel medicines that will improve people’s lives. The Galapagos group, including fee-for-service subsidiary Fidelta, has approximately 640 employees, operating from its Mechelen, Belgium headquarters and facilities in the Netherlands, France, Switzerland, the US and Croatia. More information at www.glpg.com.