Servier and Galapagos NV have started a global Phase 2 trial with S201086/GLPG1972 in knee osteoarthritis patients, titled Roccella, in which Galapagos will be eligible to receive a €9 million milestone payment upon first dosing of a patient in the trial.
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, and will be initiated in the US and Hungary with other countries expected to follow, the companies said in a press release on Wednesday. Roccella is planned to recruit approximately 850 patients in up to 15 countries, with Galapagos being responsible for the trial in the United States, where 300 patients are targeted to be recruited. Servier will run the trial in all other countries.
Its primary objective is set to demonstrate the efficacy of at least one dose of S201086/GLPG1972 compared to placebo in reducing cartilage loss after 52 weeks of treatment, according to the press release. 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.
“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”, said Lode Dewulf, Chief Patient Officer at Servier.
“The robust design of Roccella should provide deep insights into the disease-modifying potential and the safety and tolerability of this novel therapeutic candidate in patients with knee OA. We have seen clear target engagement in OA patients; now we should be able to answer how this translates to protection against cartilage breakdown,” said Dr. Walid Abi-Saab, Chief Medical Officer of Galapagos.
“Due to its unique mechanism of action based on the inhibition of cartilage degradation, S201086/GLPG1972 has the potential to help patients with osteoarthritis by altering the course of their disease. We look forward to launch the ROCCELLA Phase 2 trial as a global effort conducted jointly by Servier and Galapagos to fulfill the needs of patients suffering from osteoarthritis”, said Philippe Moingeon Head of Center for Therapeutic Innovation at Servier.