Galápagos’ oral therapy for lupus fails to meet key trial objective
GLPG3667 shows promising trends in secondary measures, according to company
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A Phase 2 clinical trial testing Galápagos‘ experimental oral therapy GLPG3667 in people with systemic lupus erythematosus (SLE) has failed to meet its main goal, although some promising trends were observed in secondary measures, Galápagos announced.
The Phase 2 trial, dubbed GALACELA (NCT05856448), tested two doses of GLPG3667 against a placebo, in addition to standard treatments, in more than 180 people with SLE. The primary objective was to determine whether more patients treated with the therapy would achieve a response in the SLE Responder Index (SRI)-4 after 32 weeks. SRI-4 is a composite measure that takes into account disease severity, disease activity, and the Physician Global Assessment.
Galápagos stated that the trial failed to meet this goal, as there was no statistically significant difference in SRI-4 response rates with GLPG3667. However, the company added that, compared with the placebo, the therapy tended to show improvements in certain secondary measures, particularly those related to skin involvement. The company described these as “numerical improvements,” meaning the difference likely wasn’t statistically significant. A statistically significant difference is unlikely to be chance.
The GALACELA trial is still ongoing, and will collect data up to 48 weeks (nearly one year). According to a press release from Galapagos, final one-year data from the study “will be essential to assess the totality of the evidence and determine potential next steps for the SLE program.”
Lupus therapy designed to reduce activity of inflammatory immune cells
In SLE, the immune system launches an attack that targets the body’s own healthy tissues. GLPG3667 is designed to reduce the activity of inflammatory immune cells that drive the disease. The daily oral therapy specifically blocks the activity of an enzyme called tyrosine kinase 2, which helps immune cells respond to pro-inflammatory signaling molecules.
In addition to the SLE results, Galapagos also announced data from a Phase 2 trial that tested GLPG3667 in people with dermatomyositis, another autoimmune disorder marked by muscle inflammation and skin rashes. The trial met its main goal, and GLPG3667 showed a generally favorable safety profile across both trials, the company stated.
“We are encouraged by the favorable safety profile observed to date, which may contribute to the differentiated profile of GLPG3667,” said Henry Gosebruch, CEO of Galápagos. “As part of our ongoing efforts to maximize the value of this program for both patients and Galapagos, we are evaluating all strategic options. 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.”
