Merck reports Phase 2b success for anti‑TL1A antibody tulisokibart in hidradenitis suppurativa
Merck announced that its investigational anti‑TL1A monoclonal antibody tulisokibart met the primary endpoint and key secondary endpoints in a Phase 2b trial in patients with moderate to severe hidradenitis suppurativa. High‑dose (480 mg Q2W) and medium‑dose (480 mg Q4W) regimens achieved 72% and 64% HiSCR50 response rates respectively, versus 35% for placebo. Safety was comparable with placebo across dose groups. The company said it will move the program into Phase 3 trials for hidradenitis suppurativa and other immune‑mediated diseases.
Why it matters
Merck expects the Phase 3 program to expand its immunology pipeline, which could improve the company’s growth outlook beyond oncology. The positive data may also lift investor sentiment toward the stock, according to analyst commentary in the source material.
Key facts
- 1The Phase 2b trial met its primary endpoint of HiSCR50 at week 16 for both high‑dose (480 mg Q2W) and medium‑dose (480 mg Q4W) regimens. finanznachrichten.de
- 2HiSCR50 response rates were 72% (n=42) for high‑dose and 64% (n=42) for medium‑dose, compared with 35% (n=44) for placebo. finanznachrichten.de
- 3Adverse events occurred in 42.9% (high‑dose), 47.6% (medium‑dose) and 52.4% (low‑dose) versus 40.9% for placebo. finanznachrichten.de
- 4Serious adverse events were 2.4% in both high‑ and medium‑dose groups, 4.8% in low‑dose, and 2.3% with placebo. finanznachrichten.de
- 5Merck plans to advance tulisokibart into Phase 3 trials for hidradenitis suppurativa and other indications. gurufocus.com
Summary written by AlphAI from 4 of 4 sources. Not investment advice. Figures are as stated by the linked sources.