Publication date: 24/10/2018
Galapagos NV (Euronext & NASDAQ: GLPG) announces topline interim results of Part 1 of the FALCON trial in cystic fibrosis (CF).
The FALCON trial is a phase 1b, multi-center, open-label, non-randomized, multiple cohorts study to assess the safety, tolerability, pharmacokinetics, and efficacy of a novel combination treatment of GLPG2451 and GLPG2222, with and without GLPG2737, in up to 24 adult patients with CF.
The trial is designed in two parts, with Part 1 being all adult CF patients homozygous for the Class II F508del mutation (n=10). The FALCON study's primary objectives include safety and PK. Secondary objectives include changes in pharmacodynamic biomarkers for CFTR activity (sweat chloride concentration and ppFEV1). The FALCON trial is being conducted in multiple sites in Europe.
Preliminary results from Part 1 of the trial show that the dual and triple combinations of GLPG2451 and GLPG2222 with and without GLPG2737, respectively, were generally well tolerated during the dosing phase. The longer-term safety follow-up is currently ongoing. All adverse events were mild to moderate. There were no deaths and no serious adverse events reported. One patient was prematurely removed from the trial during the dual combination treatment period following the development of rash (allergic skin reaction).
PK results for all components were in line with expectations based on previous data observed in healthy subjects and/or CF patients. The addition of GLPG2737 did not impact the exposure of GLPG2451 and GLPG2222.
Two weeks' treatment with the dual combination (GLPG2451 and GLPG2222) resulted in mean decrease from baseline in sweat chloride concentration of approximately 25 mmol/L and a mean increase in ppFEV1 of approximately 3%. Subsequent two-week treatment with the triple combination (GLPG2451, GLPG2222 and GLPG2737) did not result in additional enhancement of CFTR activity.
After completion of the safety follow-up, expected in Q1 2019, the full data set is expected to be assessed prior to a decision to initiate Part 2 of the trial.
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 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. Our ambition is to become a leading global biopharmaceutical company, focused on the development and commercialization of innovative medicines that will improve people's lives. The Galapagos group, including fee-for-service subsidiary Fidelta, has approximately 675 employees, operating from its Mechelen, Belgium headquarters and facilities in the Netherlands, France, Switzerland, the US and Croatia. More information at www.glpg.com.