Histopathology of osteoarthrosis of a knee joint in an elderly female patient. Credit: KGH.

Servier and Galapagos have commenced the ROCCELLA Phase 2 clinical trial to evaluate the efficacy and safety of S201086/GLPG1972 to treat patients with knee osteoarthritis (OA).

The multi-regional, randomised, double-blind, placebo-controlled, dose-ranging trial expects to enrol around 850 patients in up to 15 countries worldwide.

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As part of the trial, three different once-daily doses of S201086/GLPG1972 will be given to the patients.

The trial will initially be conducted in the US and Hungary and will be expanded to a number of countries in North and South America, Europe and Asia once the respective regulatory approvals are granted.

Galapagos will perform the trial in the US, where 300 patients are targeted to be included, while Servier will conduct the trial in other countries.

ROCCELLA’s primary endpoint is to demonstrate the efficacy of at least one dose of S201086/GLPG1972 compared to placebo in minimising cartilage loss after 52 weeks of treatment.

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“People living with osteoarthritis of the knee experience a major loss of quality of life, mainly because of the ever-present pain and increasing loss of mobility.”

Its secondary endpoints comprise safety and tolerability, various additional measures of structural progression, changes in bone area, pain, function, stiffness, and patient global assessment.

Servier chief patient officer Lode Dewulf said: “People living with osteoarthritis of the knee experience a major loss of quality of life, mainly because of the ever-present pain and increasing loss of mobility.

“Any therapeutic innovation that can prevent or slow down the underlying cartilage loss will thus address a huge unmet patient need for the many people affected by osteoarthritis in our aging populations.”

S201086/GLPG1972 is a disease-modifying osteoarthritis drug (DMOAD) candidate that intends to target a cartilage degrading enzyme called ADAMTS-5.

In the Phase l trial, S201086/GLPG1972 demonstrated safety and pharmacokinetic profiles on healthy volunteers.