Merck reports Phase 2b tulisokibart HS trial results

• Merck (NYSE:MRK) reported Phase 2b results showing tulisokibart met its primary endpoint in moderate to severe hidradenitis suppurativa.
• At Week 16, 72% of high-dose and 64% of medium-dose patients achieved HiSCR50 compared with 35% for placebo.
• Merck stated that the results will support Phase 3 development of tulisokibart in hidradenitis suppurativa.

Merck (NYSE:MRK) reported Phase 2b MK-7240-012 trial results showing investigational tulisokibart achieved the primary endpoint of Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16 in patients with moderate to severe hidradenitis suppurativa.

The randomized, double-blind, placebo-controlled study evaluated 125 patients across three tulisokibart dose groups and placebo, with high-dose and medium-dose regimens showing higher HiSCR50 response rates than placebo.

The high-dose group achieved a 72% HiSCR50 response rate and the medium-dose group achieved 64%, compared with 35% for placebo, while the low-dose group achieved 52%, and safety results were comparable between tulisokibart and placebo groups.

For secondary endpoints, HiSCR75 responses were achieved by 41% of high-dose patients, 40% of medium-dose patients and 29% of low-dose patients compared with 15% of placebo patients, while quality-of-life improvements were measured through Dermatology Life Quality Index scores.

Merck stated that the results will inform Phase 3 development of tulisokibart in hidradenitis suppurativa, with the investigational antibody also being studied across multiple immune-mediated inflammatory diseases.