Galapagos seeks to develop a robust portfolio of clinical-stage breakthrough therapies with potential to revolutionize existing treatment paradigms.
The ambition of the Galapagos team is to become a leading global biotechnology company focused on the development and commercialization of novel medicines. Management’s strategy is to leverage Galapagos’ unique and proprietary target discovery platform, which facilitates discovery and development of therapies with novel modes of action.
Key elements of Galapagos’ strategy include:
- Rapidly advance the development of filgotinib with AbbVie, in rheumatoid arthritis (RA) and Crohn’s disease (CD)
Based on the favorable safety and efficacy profile demonstrated in our Phase 2a clinical trials, filgotinib may be a promising candidate for the treatment of RA and other autoimmune diseases like CD. Topline results from DARWIN, Galapagos’ two ongoing Phase 2b trials, after 12 weeks of treatment with filgotinib in subjects with RA, are expected in April 2015. The final results from these studies after 24 weeks of treatment are expected in July 2015. Pending a successful outcome of these trials, a global Phase 3 clinical program in RA is expected to be initiated in the first half of 2016. In parallel, Galapagos is evaluating filgotinib for the treatment of CD. Results from 10 weeks of treatment in FITZROY, our 180 patient, 20-week trial of filgotinib in subjects with CD, are expected in the second half of 2015. Pending a successful outcome of the FITZROY trial, a global Phase 3 clinical program in CD is expected. Filgotinib is being developed under an exclusive collaboration agreement with AbbVie, under which agreement Galapagos expects a licensing decision by AbbVie in the second half of 2015.
- Collaborate with AbbVie to develop a cystic fibrosis (CF) franchise of oral therapies composed of novel potentiators and correctors
Galapagos is developing a novel potentiator therapy, called GLPG1837, for CF patients that have the Class III (G551D) mutation of the CFTR gene, the same mutation which is targeted by the only approved therapy for CF, Kalydeco, marketed by Vertex. However, the most common mutation in the CFTR gene, the Class II (F508del) mutation, is present in approximately 90% of the CF population and is not addressed by Kalydeco. In order to address the unmet need in patients with Class II mutations, a combination of novel potentiator and corrector molecules ultimately may be required. To that aim, Galapagos plans to develop a triple combination therapy, composed of GLPG1837 and two novel corrector molecules. In December 2014, Galapagos initiated a Phase 1 trial for GLPG1837 in healthy volunteers. Topline results from this trial are expected in the third quarter of 2015. Pending a successful outcome from this trial, Galapagos intends to initiate a Phase 2a trial with GLPG1837 in Class III patients (G551D) in the second half of 2015. For the triple combination therapy, Galapagos expects to combine GLPG1837 with a novel corrector, GLPG2222, and an additional novel corrector for which Galapagos expects to initiate pre-clinical development in the first half of 2015. By the middle of 2015 Galapagos expects to have all three components of this therapy in development. In addition, Galapagos has preliminary pre-clinical data which suggests that Galapagos candidate drugs in combination with mRNA translation agents potentially can restore clinically meaningful CFTR function in Class I mutation patients. Galapagos entered into an exclusive collaboration agreement with AbbVie to discover, develop and commercialize these and other novel CF modulators.
- Advance our Phase 2a clinical trial of GLPG1205 in UC
In December 2014, Galapagos started ORIGIN, a 60-patient, 12-week Phase 2a clinical trial of GLPG1205, an inhibitor of GPR84, a protein which is frequently overexpressed in inflammatory diseases. Galapagos expects topline data from this trial in the first half of 2016. Pre-clinical data demonstrated promising activity in an animal model, and Phase 1 data in human volunteers demonstrated a favorable safety, tolerability and pharmacodynamics, or PD, profile. GPR84 antagonists such as GLPG1205 present a novel mode of action for treatment of inflammatory diseases. Up-regulation of GPR84 on inflammatory leukocytes is found in diseases such as IBD and neuro-inflammatory disease, such as multiple sclerosis. GLPG1205 is fully proprietary to Galapagos, and management intends to develop this drug through Phase 2 independently.
- Prepare for Phase 2a clinical trial of GLPG1690 in IPF
In Q1 2015 Galapagos reported positive topline results of GLPG1690, an autotaxin inhibitor, in healthy volunteers. The molecule demonstrated favorable safety and tolerability, as well as a strong pharmacodynamic signal implying target engagement. Galapagos is currently preparing a Phase 2 study in idiopathic pulmonary fibrosis (IPF), to be filed for approval before the end of 2015. IPF is a chronic and ultimately fatal disease characterized by a progressive decline in lung function.
- Maximize and capture the value of Galapagos’ target discovery platform by becoming a fully integrated biotechnology company
Galapagos’ platform has yielded several new mode-of-action therapies across more than 15 therapeutic areas, demonstrating the potential of our technology platform. In addition to the current clinical programs, targeting inflammation, CF and pulmonary disease, Galapagos currently has 25 different target-based discovery programs advancing toward clinical development with novel modes of action. The most mature pre-clinical program is in osteoarthritis where management expects to enter a Phase 1 trial in 2015. Galapagos intends to continue to advance more clinical candidates in various therapeutic areas independently. Galapagos aims to select promising programs in specialty pharmaceutical and orphan indications for internal development and commercialization to capture greater value for shareholders and establish Galapagos as a fully integrated biotechnology company.