Apogee Therapeutics' APEX Part A meets primary endpoints with significant EASI decrease.

Apogee Therapeutics reports positive topline results from APEX Part A, meeting all primary and key secondary endpoints with a 71.0% decrease from baseline in EASI at Week 16. APG777 demonstrated a 66.9% EASI-75 (42.5% placebo-adjusted) at Week 16, the highest efficacy in a global study. The exposure-response relationship was observed across multiple key endpoints, with APEX Part B testing higher exposures and readout anticipated mid-2026. APG777 was well-tolerated with a favorable safety profile. The first patient was dosed in APG279's Phase 1b head-to-head trial versus DUPIXENT, with readout expected in 2H 2026.

Apogee Therapeutics, Inc. (Nasdaq: APGE) announced today the positive topline results from Part A of the Phase 2 APEX clinical trial of APG777, a potential best-in-class anti-IL-13 antibody, in patients with moderate-to-severe atopic dermatitis (AD). The trial met all primary and key secondary endpoints, demonstrating significant efficacy and a favorable safety profile.

Key Findings:

- Efficacy: APG777 showed a 71.0% decrease from baseline in Eczema Area Severity Index (EASI) at Week 16, meeting the primary endpoint. The EASI-75 response rate was 66.9% (42.5% placebo-adjusted), the highest observed in any global study to date.
- Exposure-Response Relationship: The trial observed an exposure-response relationship, with patients in the highest quartiles of exposure achieving the highest EASI-75 response rates.
- Safety: APG777 was well-tolerated, with a safety profile consistent with other agents in its class. Serious treatment-emergent adverse events (TEAEs) were rare, and the most common TEAEs were non-infective conjunctivitis, upper respiratory tract infection, and nasopharyngitis, with the latter two numerically lower in APG777-treated patients.
- Maintenance Dosing: The trial is evaluating 3- and 6-month maintenance dosing of APG777, with readout expected in the first half of 2026.
- Future Trials: APEX Part B, a placebo-controlled dose optimization trial, is testing higher exposures and is expected to readout mid-2026. The APG279 Phase 1b head-to-head trial against DUPIXENT is also ongoing, with readout expected in the second half of 2026.

Michael Henderson, M.D., Chief Executive Officer of Apogee Therapeutics, commented, "The results from APEX Part A demonstrate APG777's potential as a transformational therapy for patients with moderate-to-severe AD, offering improved clinical responses with quarterly or better maintenance dosing. We believe these findings further de-risk APG777's path to approval and look forward to the upcoming readouts from APEX Part B and APG279."

The Phase 2 APEX Part A trial enrolled 123 adult patients randomized 2:1 to APG777 versus placebo. The trial was designed to evaluate the efficacy and safety of APG777 in patients with moderate-to-severe AD.

The results from APEX Part A bring Apogee Therapeutics closer to achieving its vision of delivering meaningful and durable benefit to patients while significantly reducing dosing frequency compared to existing agents. The company plans to host a conference call today at 8:00 a.m. ET to discuss these findings in more detail.

References:

[1] https://www.globenewswire.com/news-release/2025/07/07/3110862/0/en/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.html