Merck reports positive phase 2 trial results for HS treatment

RAHWAY, N.J. - Merck (NYSE:MRK) shared promising Phase 2b trial outcomes on Tuesday for tulisokibart, a monoclonal antibody being studied to treat moderate to severe hidradenitis suppurativa. Presented at the European Academy of Dermatology and Venereology meeting, the research met its main goal of Hidradenitis Suppurativa Clinical Response 50 at week 16.

Out of 42 patients given the high-dose (480 mg every two weeks), 72% reached HiSCR50, compared to 35% on placebo. The medium-dose group (480 mg every four weeks) saw 64% achieve HiSCR50, while the low-dose group (240 mg every four weeks) had a 52% response rate. Low-dose patients achieved a 29% HiSCR75 response, compared to 15% in the placebo group.

The Dermatology Life Quality Index revealed mean improvements of -5.62 for the high-dose group and -3.50 for the medium-dose group, compared to -2.46 for the placebo group. Adverse events were more common in the treatment groups - 42.9% in the high-dose cohort, 47.6% in the medium-dose group, and 52.4% in the low-dose group - compared to 40.9% in the placebo group.

Serious adverse events were reported in 2.4% of the high-dose and medium-dose groups, 4.8% in the low-dose group, and 2.3% with placebo. No serious or opportunistic infections were noted.

Tulisokibart works by targeting tumor necrosis factor-like cytokine 1A and is being investigated for six different diseases, including ulcerative colitis and Crohn’s disease. Phase 3 trials are currently underway. Approximately 1 in 100 people worldwide suffer from hidradenitis suppurativa.