Merck's Tulisokibart Hits Primary Endpoint in Phase 2b Hidradenitis Suppurativa Trial
MRK sits 92% above its 52-week low of $78.03.
Summary
Merck's anti-TL1A antibody tulisokibart met its primary endpoint in a Phase 2b trial for moderate-to-severe hidradenitis suppurativa (HS), with 72% of high-dose patients achieving HiSCR50 versus 35% on placebo. The high-dose group was 480 mg Q2W (n=42), the medium-dose group was 480 mg Q4W (n=42) and achieved 64% HiSCR50, and the low-dose group was 240 mg Q4W (n=21) and achieved 52% HiSCR50; placebo had 44 patients. HiSCR75 rates were 41% for high-dose, 40% for medium-dose, and 29% for low-dose versus 15% for placebo. High-dose DLQI reduction was -5.62 versus -2.46 for placebo, medium-dose DLQI reduction was -3.50, and low-dose DLQI showed no improvement over placebo. Primary and secondary endpoints were measured at week 16. Adverse events were 42.9% for high-dose, 47.6% for medium-dose, 52.4% for low-dose, and 40.9% for placebo; serious adverse events were 2.4% to 4.8% for active and 2.3% for placebo. This is the first positive dermatology data for the anti-TL1A class and supports advancing to Phase 3 in HS. The drug is already in Phase 3 for ulcerative colitis and Crohn's disease, so this expands a key pipeline asset. The news adds a new indication to a program Merck has highlighted as a growth driver beyond Keytruda.
Updated with a Benzinga report · What changed
Updates
· Benzinga — At EADV, Merck detailed HiSCR75 rates of 41% for high-dose, 40% for medium-dose, and 29% for low-dose versus 15% for placebo, and high-dose DLQI reduction of -5.62 versus -2.46 for placebo.
- Trial identifier is MK-7240-012.
- Primary endpoint HiSCR50 was measured at week 16.
- High-dose group was 480 mg Q2W (n=42).
- Medium-dose group achieved 64% HiSCR50.
- Medium-dose group was 480 mg Q4W (n=42).
- Placebo group had 44 patients (n=44).
- Low-dose group achieved 52% HiSCR50.
- Low-dose group was 240 mg Q4W (n=21).
- Secondary endpoints were measured at week 16.
- Medium-dose DLQI reduction was -3.50.
- Low-dose DLQI showed no improvement over placebo.
- Adverse events: high-dose 42.9%, medium-dose 47.6%, low-dose 52.4%, placebo 40.9%.
- Serious adverse events: 2.4% to 4.8% for active, 2.3% for placebo.
At the time of this announcement, MRK was trading at $149.81 on NYSE in the Life Sciences sector, with a market capitalization of approximately $368.3B. The 52-week trading range was $78.03 to $156.92. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: BusinessWire.