Merck's Tulisokibart Meets Primary Endpoint in Phase 2b Hidradenitis Suppurativa Trial

Tulisokibart, an experimental treatment for hidradenitis suppurativa (HS), has met its primary endpoint in a phase 2b trial. The study found that 72% of patients receiving high-dose tulisokibart achieved the HS Clinical Response 50 (HiSCR50) at week 16, compared to 35% in the placebo group.

The HiSCR50 requires a reduction of at least 50% in total abscess and inflammatory nodule count without an increase in abscesses or draining tunnels. Merck's tulisokibart is designed to block TL1A signaling, which disrupts the immuno-fibrotic loop linked to HS progression.

Alexa B. Kimball, MD, MPH, lead investigator of the study and president and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, said 'Results from the MK-7240-012 trial are promising and suggest the potential for meaningful improvement in the management of this difficult-to-treat condition.'

The phase 2b MK-7240-012 trial included patients with moderate to severe HS who received high-dose (480 mg every 2 weeks), medium-dose (480 mg every 4 weeks), or low-dose (240 mg every 4 weeks) tulisokibart, or placebo. The study found that all three regimens demonstrated superiority over the placebo group.