Galapagos NV (GLPG) Commences GLPG2737 Phase 1 in CF

November 28, 2016 4:01 PM EST
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Galapagos NV (NASDAQ: GLPG) reports the initiation of a Phase 1 study in healthy volunteers with GLPG2737, a novel C2 corrector drug for cystic fibrosis. Initiation of the Phase 1 study triggers a $10 million milestone payment from AbbVie.

The aim of the Phase 1 study is to evaluate the safety, tolerability and pharmacokinetics of oral single and multiple ascending doses of GLPG2737. The randomized, double-blind, placebo controlled, single centre study is being conducted in at least 64 healthy volunteers in the Netherlands. In the first part of the study, single ascending doses will be evaluated. In the second part, multiple ascending doses will be administered daily for 14 days. Topline results from this Phase 1 study with GLPG2737 are expected in the second quarter of 2017.

In order to bring a more effective therapy to the majority of cystic fibrosis patients, Galapagos and AbbVie are developing a portfolio of candidates addressing three complementary components for a potential combination therapy. Novel C2 corrector GLPG2737 is the first of multiple C2 correctors being developed and is the final component needed to complete a first triple combination; this drug initiating a Phase 1 safety study marks a significant step in the progress of the companies' cystic fibrosis triple combination portfolio development. Potentiators GLPG1837 and GLPG2451 and C1 corrector GLPG2222 are already being tested in the clinic.

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 initiate a Phase 1 study with the first of our C2 correctors 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."

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