Galapagos initiates NOVESA Phase 2a trial in patients with systemic sclerosis

MECHELEN, Belgium I January 6, 2019 I Galapagos NV (Euronext & NASDAQ: GLPG) expands its clinical study program with GLPG1690 in systemic sclerosis, following the recent start of the ISABELA Phase 3 program with '1690 in IPF.

NOVESA is a double-blind, placebo-controlled Phase 2a trial evaluating the efficacy, safety and PK/PD of '1690 in patients with systemic sclerosis (SSc, or scleroderma). NOVESA is planned to recruit 30 patients with diffuse cutaneous SSc, an autoimmune disease involving multiorgan fibrosis, which has one of the highest mortality rates among rheumatic diseases[1]. One of the most visible manifestions is hardening of the skin. In diffuse cutaneous SSc, skin thickening affects several body areas, and patients have a higher risk of developing fibrosis of various internal organs, such as the lung. Currently, there are no approved drugs for this disease. SSc affects approximately 90,000 patients in the US and Europe, with a predominance of female patients (75%).

The primary endpoint of NOVESA is the modified Rodnan skin score (mRSS) at 24 weeks. 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[2]. Secondary objectives and exploratory endpoints include FVC[3], HRCT[4], quality of life as measured by QoL-Q (SHAQ)[5], and CRISS[6], a SSc disease composite score.

"In addition to our Phase 3 program in IPF[7], we are excited to broaden our development program with '1690 to a second indication," said Dr. Walid Abi-Saab, Chief Medical Officer at Galapagos. "Moreover, SSc is particularly interesting, as this disease straddles our expertise in autoimmune diseases as well as in fibrosis. Thanks to the broad MoA of '1690, which is both anti-inflammatory and anti-fibrotic, this compound has the potential to address the important unmet medical need in SSc."

About '1690

GLPG1690 is a small molecule, selective autotaxin inhibitor which is fully proprietary to Galapagos. Autotaxin is the main enzyme responsible for lysophosphatidic acid (LPA) production. LPA is a well-known pro-fibrotic and pro-inflammatory lipid, acting through at least 6 g-protein coupled receptors. Galapagos identified the autotaxin target using its proprietary target discovery platform and developed molecule '1690 as an inhibitor of this target. '1690 is currently being studied in a global Phase 3 program in IPF (ISABELA) as well as in a Phase 2 trial in SSc.

GLPG1690 is an investigational drug and its efficacy and safety have not been established.

For more information about GLPG1690: www.glpg.com/glpg-1690

For information about the studies with GLPG1690 in Systemic Sclerosis: www.clinicaltrials.gov

About Galapagos

Galapagos (Euronext & NASDAQ: GLPG) discovers and develops small molecule medicines with novel modes of action, three of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises Phase 3 through to discovery programs in inflammation, fibrosis, osteoarthritis, and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.

SOURCE: Galapagos

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