Merck's Anti-TL1A Antibody Shines in HS Phase 2b Trial

Merck's anti-TL1A antibody tulisokibart has secured a win in a phase 2b trial for treating hidradenitis suppurativa (HS), a chronic inflammatory skin condition. The study met its primary and secondary endpoints at week 16, informing phase 3 development.

The trial involved 149 patients who received either a high dose (480 mg every four weeks), medium dose (480 mg every two weeks), low dose (240 mg every four weeks), or placebo. By week 16, patients in the high-dose group achieved an HS clinical response of at least 50% reduction in total abscesses and inflammatory nodules, with no increase in abscess count.

Secondary endpoints showed that an HiSCR75 was achieved by 41% of high dose, 40% of medium dose, and 29% of low-dose patients, compared to 15% in the placebo group. Patients' quality of life with the skin condition also improved significantly, measured by the dermatology life quality index (DLQI).

The HS space is densely populated with both FDA-approved drugs and candidates in mid-stage development. Merck inherited tulisokibart in the $10.8 billion acquisition of Prometheus Biosciences in 2023.