Galapagos completes recruitment of NOVESA trial in systemic sclerosis

Mechelen, Belgium; 5 December 2019, 22.01 CET – Galapagos NV (Euronext & NASDAQ: GLPG) has completed recruitment for the NOVESA Phase 2 clinical trial with GLPG1690.

NOVESA is a double-blind, placebo-controlled Phase 2a trial evaluating the efficacy, safety and PK/PD of GLPG1690 in patients with systemic sclerosis (SSc), an autoimmune disease involving multiorgan fibrosis which has one of the highest mortality rates among rheumatic diseases¹. NOVESA recruited 33 patients with diffuse cutaneous systemic sclerosis (dcSSc). One of the most visible manifestations is hardening of the skin. In dcSSc, the skin thickening is more widespread; these patients have a higher risk of developing fibrosis of multiple internal organs, including the lung. There are no approved drugs for this disease. SSc affects approximately 124,000 patients² in the US and Europe³, with a predominance of female patients (>80%).

The primary endpoint of NOVESA is the modified Rodnan Skin Score (mRSS) at 24 weeks. mRSS measures the skin thickness as a surrogate measure of disease severity and mortality in those with dcSSc. An increase in skin thickness is associated with involvement of internal organs and increased mortality⁴. Secondary and exploratory parameters include FVC⁵, HRCT⁶, safety and tolerability, quality of life as measured by QoL-Q (SHAQ)⁷, and CRISS⁸, a SSc disease composite score. Topline results from the NOVESA trial are expected in the second half of 2020. Patients completing the NOVESA study are offered the opportunity to roll over to a long-term extension trial.

“We are excited  by the rapid enrollment into NOVESA and look forward to learning the results of GLPG1690’s efficacy and safety in patients with SSc. We consider SSc as an important and complementary indication to idiopathic pulmonary fibrosis, where a global  Phase 3 program is underway,” said Dr Walid Abi-Saab, Chief Medical Officer of Galapagos. “Thanks to the broad mechanism of action of ‘1690, which we believe is both anti-inflammatory and anti-fibrotic, this compound has the potential to address the important unmet medical need in SSc.”

About GLPG1690
GLPG1690 is a small molecule, selective autotaxin inhibitor that was inlicensed by Gilead Sciences, Inc. as part of the global R&D collaboration between Galapagos & Gilead. 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 GLPG1690 as an inhibitor of this target. GLPG1690 is currently being studied in a global Phase 3 program in idiopathic pulmonary fibrosis (ISABELA) as well as in the NOVESA trial.