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Galapagos Advances Triple Combination Therapy in Cystic Fibrosis

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Galapagos NV has announced that GLPG2665 has been selected as the first next generation corrector compound candidate. Galapagos discovered multiple C2 corrector compound series, each with a different chemical scaffold and corresponding unique and complementary mode of action. GLPG2665 is the first candidate to complete the potential triple combination therapy for the delta F508 (class II) mutation in cystic fibrosis.

GLPG2665 will now enter pre-clinical development, and is expected to enter Phase 1 studies by mid 2016. GLPG2665 in combination with corrector GLPG2222 and potentiator GLPG1837 consistently have shown restoration of healthy activity level in human bronchial epithelial (HBE) cells of patients with the Class II F508del mutation.

The combination resulted in chloride transport up to six-fold greater than Orkambi in HBE cells with the homozygous F508del mutation. Poor functioning of the CFTR channel is the major deficit in patients with cystic fibrosis.

"This is a critical step in the development of our cystic fibrosis portfolio," said Onno van de Stolpe, CEO of Galapagos. "The collaboration with AbbVie delivered novel corrector GLPG2665, the first of multiple correctors to complement our triple combination therapy. The race to bring a truly disease-modifying therapy to the vast majority of patients with CF has started, which is good news for the patients. Galapagos is fully committed to advancing our combination therapy GLPG1837, GLPG2222, and GLPG2665 as rapidly as possible."

Advancement of the third component of the triple combination therapy into development brings the Galapagos-AbbVie collaboration closer to its goal of bringing disease-modifying therapies to CF patients. Galapagos expects to enter Phase 2 studies with potentiator GLPG1837 in Class III mutation patients and a Phase 1 study with corrector GLPG2222 in healthy volunteers by filing before year-end.