Shares of Apogee Therapeutics Inc. (NASDAQ:APGE) soared 24% in Monday’s session following encouraging results from its Phase 2 APEX trial evaluating APG777, a novel treatment for moderate-to-severe atopic dermatitis.
The biotech company revealed that APG777, an experimental anti-IL-13 antibody, achieved its primary and key secondary goals after 16 weeks of treatment. Patients receiving the drug showed a 71% reduction in the Eczema Area and Severity Index (EASI) score compared to just 33.8% for those on placebo.
In terms of clinical milestones, 66.9% of patients on APG777 reached EASI-75—a benchmark indicating a 75% improvement in symptoms—marking a placebo-adjusted efficacy of 42.5%. Apogee claims these are the strongest top-line results seen in any global biologic trial targeting this condition.
“These findings are highly encouraging,” said Dr. Emma Guttman-Yassky of the Icahn School of Medicine at Mount Sinai. “The fact that APG777 achieved such outcomes after just four injections across 16 weeks highlights its strong potential.”
The study also revealed a dose-response relationship, with patients in the highest exposure quartiles reaching EASI-75 rates of 83.3% and 89.5%. Based on this, Apogee announced plans to fast-track the APEX Part B trial, which will focus on higher-dose regimens. Results are now projected for mid-2026.
Safety data were favorable as well. Serious side effects were uncommon—reported in just 1.2% of APG777 patients versus 2.4% in the placebo group. Only 2.4% of participants discontinued treatment due to adverse events.
Apogee is also exploring long-term maintenance dosing over three- and six-month intervals, with 52-week efficacy and safety data expected in the first half of 2026.
Additionally, the company has launched a Phase 1b head-to-head trial comparing its dual-action candidate APG279 (targeting IL-13 and OX40L) against market leader Dupixent. Initial results from that trial are slated for release in the second half of 2026.