Our fibrosis trials
Systemic sclerosis (SSc)
SSc is a severe autoimmune disease. One of the most visible manifestations is hardening of the skin. In 2018, 135,000 patients were diagnosed with SSc in the U.S., EU5 and Japan.1Sources: Decision Resources Group, Global Data, Galapagos Custom Research
Broadly speaking, there are two types of SSc: limited cutaneous SSc, where skin involvement is limited, and diffuse cutaneous SSc. In diffuse cutaneous SSc, which represents about 35% of the SSc patient population, skin thickening affects several body parts, and patients have a higher risk of developing fibrosis of various internal organs, such as the lung. SSc has one of the highest mortality rates among rheumatic diseases.
Currently, there are no approved disease-modifying drugs to treat this disease. Hence, SSc represents a significant unmet medical need. Current standard of care mainly consists of immunosuppressive drugs and other symptom-alleviating therapies such as methotrexate or cyclophosphamide, and aims to avoid cutaneous fibrosis, interstitial lung disease and renal crisis.
Early 2019, we initiated the NOVESA trial, a double-blind, placebo-controlled Phase 2a trial evaluating the efficacy, safety and PK/PD of GLPG1690 in up to 30 patients with diffuse cutaneous SSc.
We have received orphan drug designation for GLPG1690 in SSc from the FDA and the European Commission.
NOVESA Phase 2a in SSc
- 30 patients with progressive diffuse (multi-organ) SSc
- Recruitment in U.S. & 5 EU countries
- Primary endpoint: modified Rodnan Skin Score at week 24
- Secondary & exploratory endpoints: safety, tolerability, broad range of measures (FVC, QoL, CRISS)
The primary endpoint of NOVESA is the modified Rodnan skin score (mRSS) at week 24. The mRRS measures the skin thickness as a surrogate measure of disease severity and mortality, with an increase in thickness associated with involvement of internal organs and increased mortality. Secondary objectives and exploratory endpoints include FVC, quality of life, and other scores.
We completed recruitment for NOVESA in December 2019 and expect topline results in H2 2020.
Our fibrosis partnerships further strengthen the fibrosis pipeline
In January 2019, we announced a global collaboration with Fibrocor focused on a small molecule inhibitor program (in the lead optimization phase) against a novel target for IPF and other indications. We are responsible for the further development and commercialization of the program. In January 2020, we further expanded our collaboration with Fibrocor under which we received an exclusive option to in-license a total of four additional novel target programs after they reached the lead optimization phase.
In February 2019, we announced a global collaboration with Evotec focused on a novel small molecule program (in preclinical development) for the treatment of fibrotic diseases of the liver and other organs. Under the terms of the agreement, we are responsible for the further development and commercialization of the program.