The Investor
30 Sep 2026, 17:59
Merck’s Tulisokibart Meets Key Endpoints in Phase 2b Hidradenitis Suppurativa Study
Merck reported positive Phase 2b results for tulisokibart in patients with moderate to severe hidradenitis suppurativa, marking what the company described as the first positive Phase 2 data for an anti-TL1A monoclonal antibody in dermatology.
The study met its primary endpoint at week 16. HiSCR50 was achieved by 72% of patients receiving the high-dose regimen and 64% of those receiving the medium dose, compared with 35% for placebo. The low-dose group showed a 52% response rate in an exploratory analysis.
Key secondary measures also favored tulisokibart. HiSCR75 was reached by 41% of high-dose and 40% of medium-dose patients versus 15% with placebo, while quality-of-life scores also improved numerically in the higher-dose groups.
Safety was broadly comparable with placebo. Serious adverse events were infrequent, and no serious or opportunistic infections were reported.
Merck said the data will support advancement of tulisokibart into Phase 3 development for hidradenitis suppurativa. The drug is also being studied across several other immune-mediated inflammatory diseases, including ulcerative colitis, Crohn’s disease, rheumatoid arthritis and psoriatic arthritis.
Merck reported positive Phase 2b results for tulisokibart in patients with moderate to severe hidradenitis suppurativa, marking what the company described as the first positive Phase 2 data for an anti-TL1A monoclonal antibody in dermatology.
The study met its primary endpoint at week 16. HiSCR50 was achieved by 72% of patients receiving the high-dose regimen and 64% of those receiving the medium dose, compared with 35% for placebo. The low-dose group showed a 52% response rate in an exploratory analysis.
Key secondary measures also favored tulisokibart. HiSCR75 was reached by 41% of high-dose and 40% of medium-dose patients versus 15% with placebo, while quality-of-life scores also improved numerically in the higher-dose groups.
Safety was broadly comparable with placebo. Serious adverse events were infrequent, and no serious or opportunistic infections were reported.
Merck said the data will support advancement of tulisokibart into Phase 3 development for hidradenitis suppurativa. The drug is also being studied across several other immune-mediated inflammatory diseases, including ulcerative colitis, Crohn’s disease, rheumatoid arthritis and psoriatic arthritis.
