Galapagos NV reports positive topline results in the NOVESA Phase 2a clinical trial with investigational ziritaxestat (GLPG1690) in patients with diffuse cutaneous systemic sclerosis (dcSSc).
Ziritaxestat reached the primary endpoint of the study with a statistically significant change from baseline in the modified Rodnan Skin Score (mRSS) at Week 24, of -8.3 vs -5.7 for placebo.
600 mg ziritaxestat, n=21
Mean baseline mRSS (standard deviation)
Mean change from baseline (standard error) at Week 24, p-value(1)
-8.3 (1.2), p=0.0411
NOVESA is a double-blind, placebo-controlled Phase 2a proof-of-concept trial evaluating the efficacy, safety and tolerability of ziritaxestat (GLPG1690) in 33 patients with dcSSc. DcSSc is a severe autoimmune disease with one of the highest mortality rates among rheumatic diseases2 with no drugs currently approved to treat the overall disease. Systemic sclerosis (SSc) affects approximately 124,000 people3 in the US and Europe4, with a predominance of female patients (>80%).
Patients recruited for NOVESA included mostly females (70%) around 50 years old, with a mean disease duration of 1.9 years. Most patients enrolled were on a background immunosuppressant therapy during the course of the study.
Ziritaxestat was generally well tolerated. No deaths were reported in this study. Two patients taking ziritaxestat experienced serious adverse events versus one patient in the placebo group. Both patients in the ziritaxestat group recovered fully and are still participating in the long-term extension trial.
94% of patients (31 of the 33) who completed the NOVESA trial continued in the long-term open label extension trial.
“We are excited to see that after showing promising activity in the phase 2 FLORA trial in idiopathic pulmonary fibrosis, ziritaxestat achieved statistically significant improvements in mRSS in diffuse SSc, the primary endpoint in the NOVESA study. Keeping in mind that this is our first study in SSc and that the impact on skin is difficult to measure on a background treatment with immunosuppressants, we are pleased with the results reported today. We will now further analyze the NOVESA data to determine next steps in SSc, a disease with important unmet medical need,” said Dr Walid Abi-Saab, Chief Medical Officer of Galapagos.
Detailed results from the NOVESA trial will be presented at future medical conferences.
Ziritaxestat is an investigational drug and not approved by any regulatory authority. Its efficacy and safety have not been established.
Ziritaxestat is a small molecule, selective autotaxin inhibitor co-developed with Gilead Sciences, Inc. as part of the global 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 ziritaxestat as an inhibitor of this target. Ziritaxestat has orphan drug designation from the US and EU in both idiopathic pulmonary fibrosis (IPF) and SSc and is currently being studied in a global Phase 3 program in IPF (ISABELA), in addition to the ongoing NOVESA extension trial.
Galapagos (Euronext & NASDAQ: GLPG) discovers and develops small molecule medicines with novel modes of action, several of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises discovery through Phase 3 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.