Servier, Galapagos start Phase 2 trial for osteoarthritis med

Servier, an independent international pharmaceutical company, and Galapagos NV (Euronext & NASDAQ: GLPG) announce the start of a global Phase 2 trial with S201086/GLPG1972 in knee osteoarthritis patients: ROCCELLA. Galapagos will be eligible to receive a €9 million milestone payment upon first dosing of a patient in ROCCELLA.

Servier and Galapagos have submitted and will further submit clinical trial applications in a number of countries in North and South America, Europe and Asia. The study will now be initiated in the US and Hungary with other countries expected to follow, pending the respective regulatory approvals. ROCCELLA will be a multiregional, randomized, double-blind, placebo-controlled, dose ranging trial evaluating the efficacy and safety of three different once-daily doses of S201086/GLPG1972 in patients with knee osteoarthritis (OA).  ROCCELLA is planned to recruit approximately 850 patients in up to 15 countries. Galapagos will be responsible for ROCCELLA in the United States, where 300 patients are targeted to be recruited. Servier will run the trial in all other countries.

The primary objective of ROCCELLA is to demonstrate the efficacy of at least one dose of S201086/GLPG1972 compared to placebo in reducing cartilage loss after 52 weeks of treatment. Cartilage thickness will be measured using quantitative magnetic resonance imaging of the central medial tibiofemoral compartment of the target knee. Secondary objectives include safety and tolerability, several additional measures of structural progression, changes in bone area, pain, function, stiffness, and patient global assessment.

S201086/GLPG1972 is a disease-modifying osteoarthritis drug (DMOAD) candidate targeting efficiently a cartilage degrading enzyme called ADAMTS-5, as confirmed in two animal models. A Phase 1 trial in healthy volunteers met all its safety and pharmacokinetic targets and also demonstrated that S201086/GLPG1972 reduced by approximately 50% within two weeks the blood level of ARGS neoepitope, a biomarker for cartilage breakdown. In a more recent Phase 1b trial in OA patients in the United States, similar findings were seen over a four-week period. Specifically, S201086/GLPG1972 was well tolerated and it reduced, in a dose-dependent manner, the ARGS neoepitope blood levels by up to 50%.

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