Galapagos initiates Phase 1 study with novel CF corrector GLPG3221

• Triggers a $10 million milestone payment from AbbVie
• Sixth clinical candidate in cystic fibrosis portfolio

Mechelen, Belgium; 21 November 2017; 22.01 CET -Galapagos NV (Euronext & NASDAQ: GLPG) announces initiation of a Phase 1 study with a novel C2 corrector GLPG3221 for cystic fibrosis (CF). Galapagos receives a $10 million milestone payment from its collaboration partner AbbVie for this achievement.

The aim of the Phase 1 study is to evaluate the safety, tolerability and pharmacokinetics of GLPG3221 in healthy volunteers. The randomized, double-blind, placebo controlled, single centre study is being conducted in Belgium. Topline results from this Phase 1 study are expected to be disclosed at a future medical conference.

In order to bring a more effective therapy to the majority of CF patients, Galapagos and AbbVie have a large portfolio of candidates addressing three complementary components for a potential combination therapy. GLPG3221 is the second C2 corrector, chemically distinct from the first C2 corrector. It will form part of a triple combo expected to be tested in patients next year. Galapagos expects to initiate the first triple combo patient study (including the first C2 corrector) later this quarter.

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 have resulted in an increase in chloride transport compared to Orkambi^[1] and tezacaftor+ivacaftor in HBE cells with the homozygous and heterozygous F508del mutation. 

"We are pleased to add GLPG3221 to our growing list of clinical CF candidates," said Dr Piet Wigerinck, CSO of Galapagos. "We plan to initiate further studies within our CF portfolio, in parallel to running our first patient evaluation of a triple combo starting later this year."

GLPG3221 is an investigational therapy; its safety and efficacy have not been established.

About the Galapagos-AbbVie collaboration in CF
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 $67 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, the Netherlands, and Luxembourg.