Galapagos Initiates Phase 1 Study of GLPG2451 for Cystic Fibrosis

Galapagos Initiates Phase 1 Study of GLPG2451 for Cystic Fibrosis

Galapagos NV recently announced the initiation of a phase 1 study investigating its compound GLPG2451 for the treatment of cystic fibrosis (CF).

The molecule is the second compound in Galapagos’ extended CF-portfolio to enter the clinical trial phase according to the press release. The start of the clinical study on GLPG2451 is accompanied by a $10 million milestone payment from AbbVie, under the companies’ recently expanded collaboration agreement.

CF is a chronic, life-threatening disease caused by mutations in the CFTR gene that affect the respiratory and digestive systems. The CFTR protein encoded by the gene normally acts as a chloride channel, transporting chloride ions across cell membranes, and being involved in the production of mucus that protects the lining of airways. Mutations in this protein lead to deficient chloride ion transport followed by the obstruction of airways and glands, and deficient lung and pancreatic function.

To address such mutations, Galapagos developed a series of portfolios consisting of candidate compounds and backups, in hopes of creating the most effective triple combination treatment for CF, in collaboration with AbbVie, with the potential of covering 90% of the CF population.

Previously, Galapagos announced the advancement of development plans for a triple combination therapy based on GLPG2665, one of the multiple late binding C2 correctors discovered, the corrector GLPG2222 from the early binding (C1) corrector series, and the potentiator GLPG1837. Potentiators are drugs that intensify the effects of other drugs.

The company is currently conducting the SAPHIRA exploratory Phase 2 program with this potentiator in patients with G551D and S1251N mutations. Furthermore, Galapagos is conducting a placebo-controlled study over a range of doses of GLPG2222 in healthy volunteers in Belgium, with topline results expected in the second quarter of 2016. Among the C2 series, the company expects to enter Phase 1 studies with either one of its selected compounds, GLPG2665 or GLPG2737, in the second half of this year.

The randomized, double-blind, placebo-controlled study will assess different doses of the potentiator GLPG2451 in healthy volunteers in Belgium and the Netherlands. Topline results are expected in the fourth quarter of 2016. The recently expanded agreement between Galapagos and AbbVie raised the total milestone payments on the CF collaboration from $350 million to up to nearly $600 million.

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