Abiopharma

APOGEE THERAPEUTICS, INC. (APGE) Announces Clinical Trial Update APOGEE THERAPEUTICS, INC. (APGE) provided an update on its clinical development programs. Clinical Development Highlights:

• Drug Program: weeks
• Clinical Stage: Phase 3, Phase 2
• Collaboration: I&I
  • expected initiation of Phase 3 zumilokibart trials in moderate-to-severe atopic dermatitis starting in 2H 2026
  • targeting IL-13 – a critical cytokine in inflammation and a primary driver of AD. In the APEX Phase 2 52-week trial, zumilokibart demonstrated potential to maintain and deepen clinical responses with as little as every 3- and 6-month dosing. AD is a chronic inflammatory skin disorder which can lead to sleep disturbance, psychological distress, elevated infection risk and chronic pain, all of which significantly impact quality of life. Today’s treatments are associated with many challenges, including frequent injection regimens that can lead to poor patient compliance. Zumilokibart has pipeline-in-a-product potential with proof-of-concept demonstrated in asthma, and with expansion plans to be announced in asthma, EoE, and other I&I indications. About Apogee Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, including for the treatment of AD, asthma, EoE, Chronic Obstructive Pulmonary Disease (COPD) and other I&I indications. Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart, the company’s most advanced program, is being initially developed for the treatment of AD, which is the largest and one of the least penetrated I&I markets, as well as asthma and EoE. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. For more information, please visit https://apogeetherapeutics.com. Forward Looking Statements Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, statements regarding: Apogee’s plans for its current and future product candidates, programs, clinical trials and expansion indications; the anticipated timing of its current and future clinical trials and clinical trial results, including the APEX Phase 2 Part B 16-week readout and the expectation that it will support commencement of a Phase 3 trial in zumilokibart; its planned clinical trial designs; the potential clinical benefit, dosing regimen, safety, PK, PD and efficacy profiles and treatment outcomes of zumilokibart and any other product candidates, including combination therapies; its planned business strategies; and its expected timing for future pipeline updates, regulatory decisions and commercialization, including the planned commercial launch of zumilokibart in 2029
  • expected in the second quarter of 2026