After a long and strange year, Belgian biotech Galapagos is closing out 2025 with some mixed results for its last remaining immunology asset. The company’s tyrosine kinase 2 inhibitor GLPG3667 met the primary endpoint in a dermatomyositis study but failed to do the same when tested in systemic lupus erythematosus (SLE).
In the phase 2 GALARISSO trial, 21 patients with dermatomyositis given GLPG3667 once daily showed significantly lower disease severity at Week 24 compared to 19 patients given placebo, hitting the study’s main objective, Galapagos announced Dec. 18. Dermatomyositis is a rare autoimmune condition similar to lupus, which causes muscle weakness and skin rashes. The illness can be fatal in severe cases.
In the phase 3 GALACELA trial, however, GLPG3667 failed to beat placebo at improving SLE disease severity at Week 32, Galapagos said in the release, missing the primary endpoint. The trial is continuing for a total of 48 weeks; once those longer-term data are in, the biotech will make a decision about the future of the lupus program, according to the release.
Galapagos is also weighing its options for GLPG3667 in dermatomyositis.
“As part of our ongoing efforts to maximize the value of this program for both patients and Galapagos, we are evaluating all strategic options,” CEO Henry Gosebruch said in the release. “These include resuming potential partnering discussions announced earlier this year to accelerate development in dermatomyositis, as well as exploring opportunities to expand into other severe autoimmune diseases with significant unmet medical need.”
Gilead Sciences—which owns 25% of Galapagos and is in the middle of a 10-year R&D pact with the biotech—has waived some of its rights to allow its partner to pursue other potential suitors for GLPG3667, according to the release.
Gilead’s ownership stake gives it significant control over Galapagos, which, despite whittling down its pipeline throughout the year, has not dissolved. That’s because under Belgian law, winding down the company takes a 75% vote, Gosebruch told Fierce at the Jefferies Global Healthcare Conference in November.
“Gilead owns 25% and doesn't have any interest in doing that,” the CEO explained at the time. “Gilead wants us to go out and rebuild the company.”
Galapagos began the year with a bold plan to split the company in two, only to later backtrack. A seemingly never-ending string of strategic pivots and restructures followed, with the company consolidating its cell therapies into a subsidiary and offloading some small-molecule programs in immunology and oncology to fellow Belgian biotech Onco3R Therapeutics, which was founded this year by former Galapagos research leader Pierre Raboisson.
Galapagos later said it was abandoning its cell therapies entirely after packaging them together failed to attract any viable buyers. The wind-down will affect about 365 employees in Europe, the U.S. and China, with two facilities in the U.S. and one site each in the Netherlands, Switzerland and China shuttering.
While this year has been particularly rotten for Galapagos, the biotech’s immunology troubles started much earlier. In 2021, the company’s then-lead SIK inhibitor GLPG3970 failed to top placebo in a pair of phase 2a trials, one in rheumatoid arthritis and another in ulcerative colitis.
As a result, Galapagos pivoted to a pair of preclinical SIK inhibitors, GLP4876 and GLP4605, which are no longer listed on the biotech’s pipeline webpage. Onco3R, meanwhile, the company Galapagos transferred some undisclosed molecules to earlier this year, does list a phase 1 SIK inhibitor among its assets.