Galapagos NV reports positive topline results from ALBATROSS with GLPG2222
Galapagos NV reports positive topline results from its ALBATROSS Phase 2 study in cystic fibrosis patients with C1 corrector GLPG2222. The ALBATROSS study included 37 cystic fibrosis patients with a gating mutation on one allele and F508del mutation on the other allele. All patients were on long-term stable Kalydeco treatment at screening and continued their Kalydeco treatment throughout the study. The ALBATROSS study was fully recruited within five months. Primary objectives of this randomized, double-blinded, placebo controlled study were to evaluate the safety and tolerability and pharmacokinetics of novel C1 corrector GLPG2222 in this CF patient population. Once daily doses of 150mg GLPG2222, 300mg GLPG2222 or placebo were administered. Overall, GLPG2222 was well tolerated, with observed treatment emergent adverse events being predominantly mild or moderate, and typical for a CF patient population. There were no serious adverse events reported and no discontinuations due to adverse events. The targeted exposures of GLPG2222 were achieved in this patient study, further strengthening dosing modelling for the first investigational triple combination. Exposures achieved in patients were in line with those observed in healthy volunteers. The additional activity observed with treatment with GLPG2222 on top of Kalydeco was in line with what was observed with tezacaftor combined with Kalydeco in a Phase 2 study in this population. A statistically significant dose dependent decrease in sweat chloride concentration was observed amounting to a decrease of 6 mmol/L in the 300mg cohort. Mean percent predicted FEV1 levels overall were 70% at screening. At the end of treatment with 300mg GLPG2222, ppFEV1 levels increased by 2.2%.