Servier and Galapagos NV report that no signal of activity was observed in the topline results in their ROCCELLA Phase 2 trial with GLPG1972/S201086.
ROCCELLA is a global, double-blind, placebo-controlled, dose ranging trial evaluating the efficacy and safety of three different once-daily oral doses of GLPG1972/S201086 in 932 patients with knee osteoarthritis (OA) over 52 weeks of treatment. The study population was aged between 40 to 76 years (mean age was 63), mainly female (70%), and with a mean disease duration of 7 years.
The primary objective of ROCCELLA was to demonstrate the efficacy of at least one dose of GLPG1972/S201086 compared to placebo after 52 weeks of treatment in reducing cartilage loss of the central medial tibiofemoral compartment of the target knee via quantitative MRI.
The trial failed to meet the primary objective. The change from baseline to week 52 in cartilage thickness, in mm (SD) was -0.116 (0.27) for the placebo group and -0.068 (0.20), -0.097 (0.27) and -0.085 (0.22), for the low, medium and high dose, respectively. Statistically significant difference versus placebo was not reached in any of the treated groups.
There was no significant difference compared to placebo observed on secondary endpoints, including clinical outcomes.
Additional analyses are being conducted to fully evaluate the results, which will be presented at upcoming medical conferences.
GLPG1972/S201086 was generally well-tolerated by patients in this Phase 2 trial.
“While we are disappointed that ADAMTS-5 inhibition by GLPG1972/S201086 proved not to make a difference in this trial, we want to express our gratitude to all participating patients and investigators. This study result, while not what we hoped for, does add to the body of knowledge to help fight OA, a disease with substantial unmet medical need,” said Dr. Walid Abi-Saab, Chief Medical Officer of Galapagos.
“We are pleased to have performed this study with Galapagos. Unfortunately, the ROCCELLA results provided insufficient evidence of GLPG1972/S201086 efficacy in patients with knee osteoarthritis. We acknowledge the importance of assessing this innovative mechanism of action in the clinical setting and we will continue analyzing the data for better knowledge of the disease for the benefit of the patients and for future developments. We would like also to thank all patients and investigators for participating in this very important study,” said Dr. Patricia Belissa-Mathiot, Director of Clinical Development and R&D Chief Medical Officer at Servier.
About the ROCCELLA trial
ROCCELLA was a multi-regional, randomized, double-blind, placebo-controlled, dose ranging trial evaluating the efficacy and safety of three different once-daily oral doses of GLPG1972/S201086 in patients with knee osteoarthritis. ROCCELLA included 932 patients in 12 countries in Europe, Asia, North and South America. Galapagos was responsible for ROCCELLA in the United States, where 326 patients were recruited. Servier was responsible for this trial in 11 countries, where 606 patients were recruited.