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Investing.com -- Apogee (NASDAQ:APOG) Therapeutics, Inc. (NASDAQ:APGE) stock surged 24% on Monday after the clinical-stage biotechnology company announced positive 16-week data from its Phase 2 APEX clinical trial of APG777 in moderate-to-severe atopic dermatitis.
The company reported that APG777, its anti-IL-13 antibody, met all primary and key secondary endpoints in the trial. The treatment demonstrated a 71.0% decrease from baseline in the Eczema Area Severity Index (EASI) at Week 16, compared to 33.8% for placebo.
Notably, 66.9% of patients receiving APG777 achieved EASI-75 (a 75% improvement in symptoms), representing a 42.5% placebo-adjusted efficacy rate. According to the company, this is the highest topline and placebo-adjusted efficacy of any biologic in a global study for this condition.
"The Phase 2 Part A results are exciting, with APG777 demonstrating promising efficacy results from only four injection days over the initial 16-week induction period," said Emma Guttman-Yassky, M.D., Ph.D., from the Icahn School of Medicine at Mount Sinai in New York City.
Researchers observed an exposure-response relationship across multiple endpoints, with patients in the highest exposure quartiles achieving EASI-75 response rates of 83.3% and 89.5%. This finding has prompted the company to accelerate its APEX Part B trial, which is testing higher exposures, with results now expected by mid-2026.
APG777 was well tolerated with a favorable safety profile consistent with other agents in its class. Serious treatment-emergent adverse events were rare (1.2% vs. 2.4% in placebo), and the discontinuation rate due to adverse events was low at 2.4%.
The company is also evaluating 3- or 6-month maintenance dosing in APEX Part A, with 52-week data anticipated in the first half of 2026. Additionally, Apogee has begun dosing patients in a Phase 1b head-to-head trial of APG279 (IL-13 + OX40L) versus DUPIXENT, with results expected in the second half of 2026.
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