US pharmaceutical company Merck & Co Inc (NYSE:MRK), known as MSD outside the US and Canada, on Wednesday announced positive Phase 2b results for tulisokibart, an investigational anti-TL1A monoclonal antibody, in patients with moderate to severe hidradenitis suppurativa (HS).

The MK-7240-012 study met its primary endpoint at week 16, with 72% of patients receiving the high-dose regimen and 64% receiving the medium-dose regimen achieving the primary endpoint of Hidradenitis Suppurativa Clinical Response 50 (HiSCR50), compared with 35% for placebo.

HiSCR75 was achieved by 41% of patients in the high-dose group and 40% in the medium-dose group, versus 15% for placebo, while the high- and medium-dose groups also showed numerical improvements in Dermatology Life Quality Index scores.

Adverse events occurred in 42.9% of patients receiving high-dose tulisokibart, 47.6% receiving medium-dose, 52.4% receiving low-dose and 40.9% receiving placebo; serious adverse events were infrequent and no serious or opportunistic infections were reported.

The results represent the first positive Phase 2 data for an anti-TL1A monoclonal antibody in dermatology and are intended to inform Phase 3 development of tulisokibart in HS.

Merck said tulisokibart was designed to address immuno-fibrosis, a key driver of HS disease progression, and is being evaluated across six indications in immune-mediated inflammatory diseases.