APG777 Demonstrates High EASI-75 Response Rates in Moderate to Severe Atopic Dermatitis

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Apogee Therapeutics announced today new positive topline data stemming from part A of its phase 2 APEX clinical trial of APG777 in patients with moderate to severe atopic dermatitis (AD).¹

The anti-IL-13 antibody led to high rates of skin clearance, with an EASI-75 response rate of 66.9% at week 16—the highest topline and placebo-adjusted efficacy reported for a biologic in a global trial.

Study Outcomes

In part A of the phase 2 APEX trial (NCT06395948),² APG777 showed significant clinical activity in adults with moderate to severe AD, meeting every established primary and key secondary endpoint.

Patients treated with APG777 achieved a 71.0% average reduction in EASI scores from baseline by week 16, equivalent to more than double the improvement seen in the placebo group (33.8%). In total, 66.9% of patients treated with APG777 achieved EASI-75, compared to 24.6% on placebo.

Additional endpoints further supported the efficacy profile, including a 33.9% EASI-90 response rate (versus 14.7% with placebo) and significant improvements in validated Investigator Global Assessment 0/1 scores (34.9% with APG777 versus 17.3% with placebo).

Furthermore, researchers found that efficacy appeared to correlate with drug exposure. Patients with the highest drug levels had the highest level of response, with 83.3% and 89.5% in the top 2 exposure groups reaching EASI-75 at week 16.

Itch relief was both meaningful and rapid, with statistically significant reductions observed by the first week of treatment.

Beyond efficacy, APG777 was well-tolerated, with no injection site reactions reported, and the incidence of serious adverse events was low and comparable to placebo.

Next Steps for APG777

Following the promising results demonstrated by APG777 in the APEX part A trial, Apogee Therapeutics plans to initiate a phase 3 trial in 2026. The company has accelerated the APEX part B readout, now expected in mid-2026, to evaluate higher drug exposures.

Additionally, 52-week maintenance data from part A, testing quarterly or biannual dosing, is anticipated in the first half of 2026. A separate phase 1b head-to-head trial comparing APG279 (a dual IL-13 and OX40L inhibitor) to dupilumab (Dupixent; Regeneron Pharmaceuticals and Sanofi) is also underway, with results expected in late 2026.

Expert Insights

“Today’s results from APEX part A demonstrate strong efficacy results across all key endpoints,” said Carl Dambkowski, MD, chief medical officer of Apogee, in a news release.¹ “In addition to these potentially best-in-class results, increased response rates were observed in patients with higher exposures, supporting our exposure-response hypothesis which we continue to further test in APEX part B. Combined with a favorable safety profile, these findings reinforce APG777’s potential to deliver meaningful and durable benefit to patients while significantly reducing dosing frequency compared with existing agents.”

Emma Guttman-Yassky, MD, PhD, Waldman Professor of Dermatology and Immunology and Health System Chair of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai, echoed the significance of the efficacy results and their impact in the treatment landscape of AD.

“The phase 2 part A results are exciting, with APG777 demonstrating promising efficacy results from only 4 injection days over the initial 16-week induction period,” she said.¹ “Despite meaningful advances in atopic dermatitis treatment, there remains a significant unmet need to reduce the injection burden for patients while continuing to improve patient outcomes. I look forward to seeing the first half-life extended antibody in AD progress and I am excited about Apogee’s studies that are bringing this therapy closer to patients.”

References

1. Apogee Therapeutics announces positive 16-week data from phase 2 APEX clinical trial of APG777, its potentially best-in-class anti-IL-13 antibody, in moderate-to-severe atopic dermatitis. News release. Apogee Therapeutics. July 7, 2025. Accessed July 7, 2025. https://investors.apogeetherapeutics.com/news-releases/news-release-details/apogee-therapeutics-announces-positive-16-week-data-phase-2-apex
2. Apogee Therapeutics, Inc. A study evaluating APG777 in atopic dermatitis. ClinicalTrials.gov. Identifier: NCT06395948. Updated June 27, 2025. Accessed July 7, 2025. https://clinicaltrials.gov/study/NCT06395948