Merck’s investigational antibody tulisokibart met the primary endpoint in a Phase 2b trial in patients with moderate-to-severe hidradenitis suppurativa, a chronic inflammatory skin disease marked by painful nodules and abscesses. The company plans to use the results to guide Phase 3 development.
At week 16, 72% of patients receiving the high-dose regimen and 64% receiving the medium-dose regimen achieved Hidradenitis Suppurativa Clinical Response 50, or HiSCR50, compared with 35% of patients on placebo. HiSCR50 requires at least a 50% reduction in abscesses and inflammatory nodules without an increase in abscesses or draining tunnels.
The high-dose group received 480 milligrams every two weeks and included 42 patients. The medium-dose group received 480 milligrams every four weeks and also included 42 patients. The placebo group included 44 patients. A low-dose group receiving 240 milligrams every four weeks had a 52% HiSCR50 response rate.
On secondary measures, HiSCR75 responses—representing at least a 75% reduction in inflammatory lesions—occurred in 41% of the high-dose group, 40% of the medium-dose group and 29% of the low-dose group, versus 15% of placebo recipients.
Adverse events occurred in 42.9% of high-dose patients, 47.6% of medium-dose patients and 52.4% of low-dose patients, compared with 40.9% in the placebo group. Serious adverse events were infrequent, and no serious or opportunistic infections were reported.
Tulisokibart is a monoclonal antibody targeting TL1A, a pathway Merck is studying in inflammatory diseases. The drug is also in clinical development for ulcerative colitis, Crohn’s disease, rheumatoid arthritis, psoriatic arthritis and radiographic axial spondyloarthritis.
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