Galapagos NV and Servier reported that their ROCELLA Phase II clinical trial of GLPG1972/S201086 failed to meet its primary endpoint in osteoarthritis knee repair.
Galapagos NV and Servier reported that their ROCELLA Phase II clinical trial of GLPG1972/S201086 failed to meet its primary endpoint in osteoarthritis knee repair.
The focus of the trial was to demonstrate efficacy of at least one dose of GLPG1972/S201086 compared to placebo after 52 weeks in reducing cartilage loss of the central medial tibiofemoral compartment of the target knee via quantitative MRI. The trail failed to do so, with the change from baseline to week 52 in cartilage thickness being -0.116 for the placebo group and -0.068, -0.097 and -0.085 for the low, medium and high dose groups, respectively. There was also no statistically significant difference observed compared to placebo on any of the secondary endpoints, including clinical outcomes.
In July 2017, Servier exercised its option to develop GLPG1972/S201086 from Galapagos, picking up global commercial rights outside the U.S. The drug’s mechanism of action targets a cartilage degrading enzyme called ADAMTS-5. Phase I trials hit all safety and pharmacokinetic targets, and in healthy volunteers reduced ARGS neoepitope, a biomarker associated with cartilage breakdown, by more than 50% within two weeks.
At the time, Galapagos received a €6 million license fee from Servier and was eligible for a total of €290 million in success-based milestones.
The ROCELLA trial was a multi-regional, randomized, double-blind, placebo-controlled, dose ranging study evaluating three different once-daily oral doses of the drug in patients with knee osteoarthritis. It included 932 patients in 12 countries in Europe, Asia, North and South America. Galapagos handled the trial in the U.S., which included 326 patients. Servier handled the trial of 606 patients in 11 countries.
“While we are disappointed that ADAMTS-5 inhibition by GLPG1097/S201086 proved not to make a difference in this trial, we want to express our gratitude to all participating patients and investigators,” said Walid Abi-Saab, Galapagos’ chief medical officer. “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 companies are running additional analyses on the data and plan to present it at an upcoming medical conference. The drug had Fast Track designation from the U.S. Food and Drug Administration (FDA) in osteoarthritis.
“We are pleased to have performed this study with Galapagos,” said Patricia Belissa-Mathio, director of Clinical Development and R&D chief medical officer at Servier. “Unfortunately, the ROCELLA results provided insufficient evidence of GLPG1082/S20186 efficacy in patients with knee osteoarthritis. We acknowledge the importance of assessing this innovative mechanism of action in the clinical setting and we will continue analyzing the data for better knowledge of the disease for the benefit of the patients and for future developments. We would like also to thank all patients and investigators for participating in this very important study.”
Galapagos had better news earlier this week with Gilead Sciences, when they presented late-breaking data demonstrating the efficacy and safety of filgotinib, an oral, daily JAK1 preferential inhibitor for ulcerative colitis. The data was from the Phase IIb/III SELECTION trial and it demonstrated a significantly higher proportion of patients receiving filgotinib 200 mg compared to placebo achieved clinical remission at Week 10 and maintained remission through Week 58. Also, significantly more patients receiving filgotinib achieved corticosteroid-free remission at six months. They presented the data at the 2020 United European Gastroenterology Week (UYEGW) Virtual Meeting.
