Merck & Co (MSD) has reported that the Phase IIb MK-7240-012 study of its investigational humanised monoclonal antibody, tulisokibart, achieved its primary endpoint for patients with moderate to severe hidradenitis suppurativa (HS).
The multi-centre, randomised, double-blind, placebo-controlled trial demonstrated that both high- and medium-dose regimens achieved superiority over placebo at week 16.
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In the study, 72% of patients in the high-dose arm (480mg every two weeks; n=42) and 64% in the medium-dose arm (480mg every four weeks; n=42) achieved a Hidradenitis Suppurativa Clinical Response 50 (HiSCR50).
These represented improvements of 37% and 29% compared with the placebo arm (35%; n=44). In an exploratory analysis, the low-dose group (240mg every four weeks; n=21) recorded a 52% response rate, a 17% improvement against placebo.
At week 16, non-ranked key secondary endpoints also demonstrated numerical improvements compared with placebo.
A HiSCR75 response was attained by 41% of high-dose, 40% of medium-dose, and 29% of low-dose participants, compared to 15% in the placebo cohort.
Patients in the high- and medium-dose groups also saw mean reductions from baseline in the Dermatology Life Quality Index (DLQI) of -5.62 and -3.50, respectively, versus a -2.46 change for placebo, while the low-dose group showed no improvement over placebo.
Adverse events occurred in 42.9% of high-dose, 47.6% of medium-dose, and 52.4% of low-dose participants, compared with 40.9% of those receiving placebo.
Serious adverse events were reported in 2.4% of patients in both the high- and medium-dose cohorts, 4.8% in the low-dose cohort, and 2.3% in the placebo group, with no serious or opportunistic infections observed.
MSD Research Laboratories vice-president and immunology clinical research therapeutic area head Dr Aileen Pangan said: “We are excited to expand the clinical data for tulisokibart beyond inflammatory bowel disease with these positive Phase IIb results—the first for the anti-TL1A class in dermatology. We look forward to advancing tulisokibart to Phase III for patients living with HS.”
In August, Sarah Cannon Research Institute and MSD entered a collaboration aimed at increasing patient access to oncology clinical trials at community sites across the US.
