Pfizer's Trispecific Tilrekimig Hits Phase 2 Primary Endpoint in Atopic Dermatitis
PFE sits 21% above its 52-week low of $23.62.
Summary
Pfizer's investigational trispecific antibody tilrekimig met its Phase 2 primary endpoint in moderate-to-severe atopic dermatitis, with EASI-75 response rates of 47.8% to 62.5% across doses versus 9.1% to 19.9% for placebo. Detailed data showed up to 62.5% achieved EASI-75, with statistically significant increases across all doses vs placebo at Week 16. The drug also showed meaningful itch reduction and a clean safety profile, with no dose-dependent adverse events and lower rates of conjunctivitis and injection-site reactions than IL-4Rα inhibitors. Rates of treatment-emergent adverse events were comparable between the on-drug and off-drug arms. Pfizer has already initiated Phase 3 trials in atopic dermatitis and asthma, plus a Phase 2b/3 in COPD, signaling confidence in the program. The Phase 3 pivotal program includes two Phase 3 trials targeting atopic dermatitis and another targeting asthma. This is a potential first-in-class mechanism targeting IL-4, IL-13, and TSLP simultaneously, which could differentiate it from current biologics like dupilumab. The data were presented at EADV and build on previously announced topline results, but the detailed efficacy and safety numbers are new and strengthen the case for a blockbuster dermatology franchise.
Updated with a Seeking Alpha report · What changed
Updates
· Seeking Alpha — Detailed data showed up to 62.5% achieved EASI-75, with statistically significant increases across all doses vs placebo at Week 16.
- Phase 3 Program — The Phase 3 pivotal program includes two Phase 3 trials targeting atopic dermatitis and another targeting asthma.
- Safety — Rates of treatment-emergent adverse events were comparable between the on-drug and off-drug arms.
- Trial Design — The Phase 2 trial was conducted in adults with moderate-to-severe atopic dermatitis.
- Efficacy Measure — EASI-75 is defined as at least a 75% reduction in the Eczema Area and Severity Index.
All 4 details
- Rates of treatment-emergent adverse events were comparable between the on-drug and off-drug arms.
- The Phase 3 pivotal program includes two Phase 3 trials targeting atopic dermatitis and another targeting asthma.
- The Phase 2 trial was conducted in adults with moderate-to-severe atopic dermatitis.
- EASI-75 is defined as at least a 75% reduction in the Eczema Area and Severity Index.
At the time of this announcement, PFE was trading at $28.59 on NYSE in the Life Sciences sector, with a market capitalization of approximately $162.6B. The 52-week trading range was $23.62 to $29.21. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: BusinessWire.