The Phase 1 study, being conducted in Belgium, will evaluate the safety and tolerability of GLPG3221, and seeks to understand how the investigational therapy is processed once inside the body.
Healthy volunteers will be randomized to receive either the C2 corrector or a placebo.
The study is part of a collaborative agreement between Galapagos and AbbVie, established in September 2013. The aim of the collaboration is to discover, develop, and commercialize potentiator and corrector molecules for the treatment of CF.
In 2016 the partners announced an expansion of their collaborative agreement to develop a triple combination therapy able to treat 90 percent of all CF patients.
Studies have shown that triple combinations of CF compounds lead to restoration of healthy activity levels in assays with human bronchial epithelial (HBE) cells of patients with the F508del mutation in the CFTR gene (the gene that is defective in CF).
These triple combos have also resulted in an increase in chloride transport (which is impaired in CF) superior to that observed with Vertex Pharmaceuticals’ Orkambi (lumacaftor/ivacaftor) and tezacaftor + ivacaftor in HBE cells from CF patients.
“We are pleased to add GLPG3221 to our growing list of clinical CF candidates,” Piet Wigerinck, chief scientific officer of Galapagos, said in a press release. “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 the second C2 corrector of the portfolio and will form part of a triple combo expected to be tested in CF patients in 2018.
Topline results should be presented soon, at a specialty medical conference.
As per the terms of the agreement, this Phase 1 trial triggers a $10 million milestone payment from AbbVie to Galapagos. Once Galapagos successfully completes clinical development through the completion of Phase 2 studies, AbbVie will be responsible for Phase 3 development, with financial returns to Galapagos.
Galapagos has commercial rights over the therapies in China and South Korea and has an option to co-promote in Belgium, the Netherlands and Luxembourg.