Galapagos NV has expanded its clinical study program with GLPG1690 in systemic sclerosis (SSc), following the recent start of the ISABELA Phase III program with ’1690 in idiopathic pulmonary fibrosis (IPF).
NOVESA is a double-blind, placebo-controlled Phase IIa trial evaluating the efficacy, safety and PK/PD of ’1690 in patients with systemic sclerosis. 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. 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. Secondary objectives and exploratory endpoints include FVC, HRCT, quality of life as measured by QoL-Q (SHAQ), and CRISS, a SSc disease composite score.
“In addition to our Phase III program in IPF, 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 mode of action of ’1690, which is both anti-inflammatory and anti-fibrotic, this compound has the potential to address the important unmet medical need in SSc.”