Galapagos announces topline data from knee osteoarthritis trial
Galapagos NV (NASDAQ:GLPG) reported positive data from its ROCCELLA Phase 2 trial with GLPG1972/S201086. The company is collaborating with Servier for this program. Galapagos reported that the data did not show any signal of activity and the trial failed to meet its primary objective.
ROCCELLA is a global, double-blind, placebo-controlled, dose ranging trial. It aimed to assess the efficacy and safety of three different once-daily oral doses of GLPG1972/S201086 in treating knee osteoarthritis. Dr. Walid Abi-Saab, Chief Medical Officer of Galapagos said, “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.”
The primary endpoint of the trial was to show the efficacy of the drug candidate in reducing cartilage loss of the central medial tibiofemoral compartment of the target knee. The trial would have met its primary objective if even one dose had shown the impact after 52 weeks of treatment. The effect had to be measured through a quantitative MRI. The change from baseline to week 52 in cartilage thickness was -0.068mm, -0.097mm and -0.085mm for the low, medium and high dose, respectively. For the placebo group, the change was measured at -0.116mm. None of the treated groups showed statistically significant advantage over the placebo.
Even for the secondary endpoints such as clinical outcomes, the drug candidate failed to show statistically significant different results. However, GLPG1972/S201086 was found to be generally well-tolerated by patients in this Phase 2 trial.
ROCCELLA trial recruited 932 patients in 12 countries across the world. Galapagos had the responsibility
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