We seek to develop a robust portfolio of breakthrough therapies. Our ambition is to become a fully integrated biopharmaceutical company focused on the development and commercialization of novel medicines. Our strategy is to leverage our unique and proprietary target discovery platform, which facilitates discovery and development of therapies with novel modes of action which address the root causes of the disease.
Key elements of our strategy include:
- Rapidly advance the development and commercialization of filgotinib with our collaboration partner Gilead in RA, CD, UC and potentially other inflammatory diseases
Based on the results from our Phase 2 clinical trials, we believe that filgotinib is a promising candidate for the treatment of RA, CD, UC and potentially other inflammatory diseases. Our collaboration partner Gilead initiated Phase 3 clinical programs in RA, CD and UC in 2016. We retained an option to co-promote filgotinib with Gilead in the UK, Germany, France, Italy, Spain, the Netherlands, Belgium, and Luxembourg; exercising this option would enable us to build a commercial organization and further progress our ambition to become a fully integrated biopharmaceutical company.
- Collaborate with our collaboration partner AbbVie to develop a CF franchise of triple combination oral therapies
In order to address the unmet need in CF patients with Class II and other mutations in the CFTR gene, we aim to develop a triple combination therapy comprising a potentiator and two corrector molecules. Our most advanced candidate drug potentiator GLPG1837, showed promising activity and favorable safety, with observed treatment emergent adverse events being predominantly mild or moderate, in CF patients with the Class III mutation of the CFTR gene in a Phase 2 trial late in 2016. This trial also provided data necessary to validate our in vitro assays and dosing modelling for developing a triple combination therapy. We initiated a Phase 1 trial for a second potentiator candidate GLPG2451 in May 2016. We reported positive topline results from a Phase 1 trial for our C1 corrector candidate, GLPG2222, in June 2016 and initiated a Phase 2 trial on top of Kalydeco®1Kalydeco® is a potentiator drug marketed by Vertex Pharmaceuticals. in Class III mutation patients in January 2017. We initiated a Phase 1 trial for our C2 corrector GLPG2737 in November 2016. We dosed the first healthy volunteer with a combination of GLPG2451 and GLPG2222 in February 2017. We aim to evaluate a once-daily, oral, triple combination therapy in CF patients starting in mid-2017, with additional trials with novel CF compounds initiating throughout 2017. In March 2017 we initiated a Phase 1 trial with GLPG3067. We have an exclusive collaboration agreement with AbbVie to jointly discover, develop, and commercialize these novel CF modulators.
- Advance GLPG1690 in patient clinical trials in IPF
We have completed the enrollment of IPF patients in a Phase 2a trial evaluating target and disease biomarker changes during three months’ treatment with autotaxin inhibitor GLPG1690 or placebo, and we intend to disclose topline results of this trial in the second half of 2017. We have worldwide development and commercialization rights for GLPG1690.
- Advance GLPG1972 in OA patient clinical trials in the United States
In June 2016, we announced that a Phase 1 first-in-human trial of GLPG1972, a novel mechanism of action medicine for the treatment of osteoarthritis (OA), showed the drug reduced a cartilage breakdown biomarker in healthy volunteers by up to 60% within two weeks. We retain all development and commercialization rights to this compound in the United States (U.S.), and we intend to initiate clinical trials of GLPG1972 in the U.S. in 2017. Additional data resulting from an ongoing non-clinical program expected in the second quarter of 2017 will enable our collaboration partner Servier to make a decision regarding exercising its option to license the compound for further development in OA patient trials outside the U.S.
- Advance MOR106 in AtD patient clinical Phase 1 trials with our collaboration partner MorphoSys
In April 2016, we initiated a Phase 1 first-in-human trial and in October 2016, we announced first dosing of an atopic dermatitis (AtD) patient with MOR106, a novel human monoclonal antibody medicine in development with MorphoSys in a Phase 1b trial. MOR106 targets IL17-C, a novel antibody target discovered by us. MorphoSys and we share costs and potential benefits equally in this collaboration. Topline data from the Phase 1b trial with MOR106 are expected in the second half of 2017.
- Maximize and capture the value of our target discovery platform by becoming a fully integrated biopharmaceutical company
Our platform has yielded many new mode-of-action investigational therapies across multiple therapeutic areas. Our most mature pre-clinical programs are GLPG2534 for AtD and GLPG2938 for IPF, both of which we plan to take into Phase 1 trials in 2017. Additionally, we are exploring the potential of development programs and pre-clinical drug candidates in ankylosing spondylitis, psoriatic arthritis, lupus, nonalcoholic steatohepatitis, type 2 diabetes, and hepatitis B. We aim to initiate a Phase 3 trial every other year, while conducting three proof-of-concept trials, delivering eight new validated targets and three pre-clinical candidate drugs every year. We aim to select promising programs for internal development and commercialization to capture greater value for shareholders and establish ourselves as a fully integrated biopharmaceutical company.
1 Kalydeco® is a potentiator drug marketed by Vertex Pharmaceuticals.