Galapagos and Servier’s GLPG1972 has failed to enhance outcomes in knee osteoarthritis sufferers in a part 2 medical trial. The failure of the ADAMTS-5 inhibitor is a setback for Galapagos’ efforts to broaden its alternatives past its faltering JAK1 inhibitor filgotinib.
Servier teamed up with Galapagos to develop new osteoarthritis therapies in 2010, happening to land the ex-U.S. rights to GLPG1972 in 2017. The companions centered on ADAMTS-5 in mild of proof that will increase within the exercise of the aggrecanase set off osteoarthritis by driving cartilage aggrecan loss. In preclinical work, GLPG1972, also called S201086, confirmed chondroprotective results, main the companions to maneuver into the clinic and persuading Gilead Sciences to safe an choice on the U.S. rights.
Gilead can train its $250 million choice upon the completion of the part 2 ROCCELLA trial. With top-line knowledge from the research now accessible, there’s little proof to recommend that Gilead will take up its choice or that GLPG1972 has a future at any firm. In describing the info, Galapagos and Servier mentioned “no sign of exercise was noticed within the topline outcomes.”
The first endpoint checked out modifications in cartilage thickness from baseline to Week 52 in sufferers on placebo in comparison with that of their friends who acquired one in every of three doses of GLPG1972. Cartilage thickness lowered by 0.116 mm in placebo sufferers over the course of the medical trial. The smallest discount, 0.068 mm, was seen within the low-dose group, however that fell wanting statistical significance.
With the medium and excessive doses performing comparably to placebo, with reductions of 0.097 mm and 0.085 mm, respectively, the first endpoint knowledge is essentially devoid of optimistic indicators. The awful image was accomplished by the failure of GLPG1972 to beat placebo towards secondary endpoints, together with some that checked out medical outcomes.
Going into 2020, the anticipated GLPG1972 readout was a footnote for Galapagos in a yr set to be dominated by efforts to carry Gilead-partnered JAK1 inhibitor filgotinib to market. Nevertheless, with the FDA issuing an entire response letter to filgotinib, at finest delaying entry to a aggressive market, the deal with Galapagos’ different pipeline prospects has elevated.
“We had at all times seen the trial as excessive threat however be aware the failure is an extra blow to sentiment after the filgotinib U.S. FDA rejection in August, which has additionally led to heightened scrutiny on upcoming pipeline readouts,” analysts at Jefferies wrote in a be aware to traders.
The ROCCELLA readout is the primary of a collection of information drops that may present whether or not Galapagos has a pipeline able to offsetting diminished expectations for filgotinib. Later this yr, Galapagos is ready to share part 2a knowledge on GLPG1205 in idiopathic pulmonary fibrosis (IPF). An interim evaluation of a part three trial of ziritaxestat in IPF is scheduled for subsequent yr. With Gilead paying $5 billion upfront to safe broad entry to Galapagos’ pipeline, the info have implications past the Belgian biotech.