Combination therapy for cystic fibrosis tested in clinical trial

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Mechelen, Belgium; 23 February 2017 – Galapagos NV (Euronext & NASDAQ: GLPG) announces dosing of the first healthy volunteer with a combination of novel corrector GLPG2222 and novel potentiator GLPG2451 for cystic fibrosis in a Phase 1 study.

After completion of the dosing of GLPG2451 as a monotherapy, in the new cohorts the safety, tolerability and PK of 14 days co-administration of GLPG2451 and GLPG2222 is being evaluated. The randomized, double-blind, placebo controlled, single center study is being conducted in at least 40 healthy volunteers in Belgium.

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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. In the present study, potentiator GLPG2451 and C1 corrector GLPG2222 are evaluated as potential components of this triple combination.

Triple combinations of CF compounds in the portfolio have consistently shown restoration of healthy activity levels in in vitro assays with human bronchial epithelial (HBE) cells of patients with the F508del mutation. These combinations result in an increase in chloride transport compared to Orkambi[1] in HBE cells with the homozygous F508del mutation.

“We are pleased to have initiated our first dual combo Phase 1 study with our potentiator and C1 corrector for cystic fibrosis,” said Dr Piet Wigerinck, CSO of Galapagos. “This step brings us closer to our goal of initiating a patient evaluation of a triple combination therapy by mid-2017.”

About the Galapagos-AbbVie collaboration in cystic fibrosis

In September 2013 Galapagos and AbbVie entered into a global collaboration agreement focused on the discovery and worldwide development and commercialization of potentiator and corrector molecules for the treatment of CF. Under the terms of the agreement, AbbVie made an upfront payment of $45 million to Galapagos. Upon successful completion by Galapagos of clinical development through to completion of Phase 2, AbbVie will be responsible for Phase 3, with financial contribution by Galapagos. Galapagos has earned $50 million in milestone payments to date and is still eligible to receive up to approximately $550 million in total payments for developmental and regulatory milestones, sales milestones upon the achievement of minimum annual net sales thresholds and additional tiered royalty payments on net sales, ranging from mid-teens to 20%. Galapagos has commercial rights to China and South Korea, and has an option to co-promote in Belgium, Netherlands, and Luxembourg.

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