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Thursday, March 26th, 2026

Apogee Therapeutics Reports Positive 52-Week Phase 2 Results for Zumilokibart in Atopic Dermatitis With Durable Efficacy and Infrequent Dosing 13





Apogee Therapeutics Announces Positive Phase 2 Results for Zumilokibart (APG777)

Apogee Therapeutics Reports Positive 52-Week Phase 2 Data for Zumilokibart (APG777) in Atopic Dermatitis

Key Highlights from the Clinical Study

  • Durable Maintenance and Deepening of Response: Apogee Therapeutics, Inc. (Nasdaq: APGE) has announced robust 52-week data from Part A of its Phase 2 APEX trial for zumilokibart (APG777), an anti-IL-13 antibody being developed for moderate-to-severe atopic dermatitis (AD).
  • Impressive Efficacy with Infrequent Dosing: The trial demonstrated that 75% and 85% of patients maintained EASI-75 (≥75% improvement in Eczema Area and Severity Index) with every 3- and 6-month dosing, respectively. Additionally, 86% and 78% of patients maintained vIGA 0/1 (clear or almost clear skin) for 3- and 6-month dosing.
  • Deepening of Clinical Response: The study observed continued improvement across all lesional and itch endpoints over the year, even among patients who did not fully respond in the first 16 weeks, highlighting the potential for progressive efficacy with long-term use.
  • Well Tolerated Safety Profile: Zumilokibart was well tolerated with a safety profile consistent with other agents in its class. The most common treatment-emergent adverse events (TEAEs) were noninfective conjunctivitis, upper respiratory tract infection, and nasopharyngitis.
  • Potential to Transform Treatment Paradigm: Zumilokibart could become the first 6-month dosed therapeutic for AD, with the potential to reduce injection frequency from up to 26 per year (current therapies) to just 2-4 times per year.
  • Market Expansion: Proof-of-concept has also been demonstrated in asthma, and the company is planning expansion into asthma, eosinophilic esophagitis (EoE), and other inflammatory and immunology (I&I) indications.

Important Information for Shareholders

  • Clinical Progress and Upcoming Milestones: The APEX Part B (placebo-controlled dose optimization with 347 patients) will have a 16-week readout expected in Q2 2026. This is anticipated to support initiation of Phase 3 trials for moderate-to-severe AD in the second half of 2026, targeting potential commercial launch in 2029.
  • Late-Breaking Presentation: The 52-week results will be presented at the 2026 American Academy of Dermatology Annual Meeting, which may increase visibility and credibility among clinicians and investors.
  • Pipeline and Corporate Strategy: Apogee is positioning zumilokibart as a pipeline-in-a-product, with expansion plans in multiple high-value markets (AD, asthma, EoE, COPD). The company’s antibody programs utilize advanced engineering to optimize half-life and efficacy, aiming for differentiated dosing and best-in-class profiles.
  • Potential Stock Price Impact: The positive trial results, particularly the ability to maintain and deepen response with significantly less frequent dosing, are likely to be price-sensitive. The initiation of pivotal Phase 3 trials later in 2026 and a pathway to commercial launch in 2029 could materially impact shareholder value. The announcement of expansion into other indications increases the potential market opportunity and may further drive valuation.
  • Risks and Forward-Looking Statements: The company cautions that actual results may differ due to various risks including clinical trial outcomes, regulatory decisions, macroeconomic conditions, and the unpredictable nature of drug development.
  • Investor and Media Contacts: Investors can reach out to Noel Kurdi, VP Investor Relations, and media inquiries can be directed to Dan Budwick at 1AB Media.

Details of Upcoming Events

  • Conference Call: Management will host a webcast today at 8:00 a.m. ET to discuss the results, accessible via the Apogee Therapeutics investor website.
  • Academy Presentation: Oral presentation scheduled for March 28, 2026, at 10:00 AM at the Bellco Theatre, Colorado Convention Center, Denver.

About Zumilokibart (APG777) and Apogee Therapeutics

  • Zumilokibart is a novel, subcutaneous, extended half-life monoclonal antibody targeting IL-13, a major driver of AD. The trial results suggest it may offer durable disease control with infrequent dosing, helping overcome compliance challenges associated with frequent injections.
  • Apogee Therapeutics is a clinical-stage biotech company advancing optimized biologics for large I&I markets. The portfolio includes programs for AD, asthma, EoE, COPD, and other indications, using validated targets and advanced engineering to create differentiated therapies.

Disclaimer


This article is for informational purposes only and does not constitute investment advice. The content may contain forward-looking statements subject to risks and uncertainties, including those described in Apogee Therapeutics’ filings with the U.S. Securities and Exchange Commission. Investors should review these filings and consult their financial advisors before making any investment decisions. Apogee Therapeutics expressly disclaims any obligation to update any statements in this article except as required by law.




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