Mechelen, Belgium; 19 December 2014 – Galapagos NV (Euronext: GLPG) announces the initiation of the first Phase 1 study with GLPG1837. This novel potentiator is designed as a CFTR targeted therapy for cystic fibrosis (CF) patients who carry class III/IV mutations (e.g., G551D). In combination with corrector GLPG2222, this potentiator will also be developed for patients affected by the F508del mutation, the most prevalent mutation in CF patients. This achievement triggers a milestone payment of $10 million 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 GLPG1837. The randomized, double-blind, placebo-controlled, single center study is being conducted in at least 40 healthy volunteers in Belgium. In the first part of the study, single ascending doses will be evaluated. In the second part, the new compound will be administered daily for 14 days. Topline results from this Phase 1 study with GLPG1837 are expected in the second half of 2015.
“GLPG1837 forms the first part of our strategy to develop novel and best-in-class therapies for CF. We are developing GLPG1837 as planned, with the Phase 1 study now initiated, and a backup potentiator well advanced,” said Dr Piet Wigerinck, Chief Scientific Officer of Galapagos. “This is Galapagos’ tenth candidate drug program to initiate Phase 1 clinical studies, a landmark achievement for our R&D team.”
Galapagos initiated its research in CF in 2005. In September 2013 Galapagos signed an agreement with AbbVie in which they will work collaboratively to develop and commercialize oral drugs that address the main mutations in CF patients, including F508del and G551D. 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 II, AbbVie will be responsible for Phase III, with financial contribution by Galapagos. Galapagos is eligible to receive up to $360 million in total additional payments for developmental and regulatory milestones, sales milestones upon the achievement of minimum annual net sales thresholds and additional double-digit royalty payments on net sales.
About Cystic Fibrosis
Cystic fibrosis (CF) is a hereditary disease of the entire body which leads to severe disability and early death in many cases. Symptoms include frequent lung infections, sinus infections, poor growth, and diarrhea. The cause is a defect in a gene which encodes for cystic fibrosis transmembrane conductance regulator (CFTR), a protein which regulates components of sweat, mucus, and digestive juices. CF affects approximately 70,000 people worldwide. Patient symptoms are treated with antibiotics and other medicines. There currently is no cure for the disease, and the predicted median age of survival is in the late 30s. New therapies in development for the main mutation, delF508 affecting 70% of CF patients, involve combining two drugs: a corrector to restore the mutation plus a potentiator to allow efficient opening of the CF channel.