Galapagos has dosed the first patient in Phase ll ROCCELLA trial investigating the efficacy and safety of GLPG1972/S201086 for the treatment of patients with knee osteoarthritis (OA).
The multiregional, randomised, double-blind, placebo-controlled, dose-ranging trial intends to examine three different once-daily doses of GLPG1972/S201086.
The trial is expected to enrol around 850 patients in various countries across Europe, Asia, North America and South America.
Its primary endpoint is to demonstrate the efficacy of at least one dose of GLPG1972/S201086 versus placebo in minimising cartilage loss after 52 weeks of treatment. The cartilage loss will be measured by magnetic resonance imaging (MRI).
The trial’s secondary endpoints comprise safety and tolerability. Its additional goals are structural progression, improvement in pain, function, stiffness, and patient global assessment.
ROCCELLA will be conducted as part of a collaboration between Galapagos and Servier.
Galapagos will look after the trial in the US, where 300 patients are expected to be enrolled, while Servier will conduct the trial in all other countries.
Galapagos in a statement said: “GLPG1972/S201086 is a disease-modifying osteoarthritis drug (DMOAD) candidate that, in two animal models, has been shown to efficiently target a cartilage degrading enzyme called ADAMTS-5.
“A Phase l trial in healthy volunteers met all of its safety and pharmacokinetic targets and also demonstrated that GLPG1972/S201086 reduced the blood level of the ARGS neoepitope by approximately 50% within two weeks.”
There are currently no treatments available for countering OA, which is a highly prevalent and disabling pathology.