Merck announced that its experimental drug tulisokibart met the main goal of a mid-stage study for hidradenitis suppurativa, a chronic skin disease. In the trial, 72% of patients on the highest dose achieved a 50% reduction in skin lesions, outperforming analyst expectations. Merck acquired the drug via its $10.8 billion purchase of Prometheus Biosciences in 2023, aiming to bolster its immunology pipeline and offset the upcoming patent expiration of its blockbuster cancer drug Keytruda.
Efficacy and safety trial results
- ▪Merck reported that safety was comparable between the treatment and placebo groups in the mid-stage study of Merck's experimental drug tulisokibart for hidradenitis suppurativa
- ▪Merck announced on Wednesday, September 30, 2026, that its experimental drug tulisokibart met the main goal of a mid-stage study by significantly reducing inflammatory skin lesions in patients with hidradenitis suppurativa
- ▪In a mid-stage study, 72% and 41% of patients receiving Merck's experimental drug tulisokibart at the highest dose achieved at least 50% and 75% reductions in inflammatory skin lesions after 16 weeks, compared to 35% and 15% on placebo, respectively
Strategic impact on Merck's portfolio
- ▪Merck is counting on the experimental drug tulisokibart to help offset the eventual loss of exclusivity on Merck's blockbuster cancer immunotherapy, Keytruda, later this decade
- ▪The positive mid-stage trial results for tulisokibart in hidradenitis suppurativa, announced by Merck on Wednesday, bolster Merck's strategic push into immunology treatments
Hidradenitis suppurativa treatment market
- ▪RBC Capital analysts project the market for hidradenitis suppurativa treatments to exceed $10 billion by 2035
- ▪Currently approved treatments for the chronic skin disease hidradenitis suppurativa include AbbVie's Humira and Novartis' Cosentyx
RBC Capital analyst views
- ▪RBC Capital analysts had expected about 52% to 58% of patients in the mid-stage study of Merck's experimental drug tulisokibart for hidradenitis suppurativa to achieve at least a 50% reduction in inflammatory skin lesions
- ▪RBC Capital analysts stated that biologic medicines are currently used by a small proportion of patients and treatment rates are expected to increase as new therapies become available
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