Apogee Begins Dosing in Phase 2 APEX Trial of APG777 for Dermatitis

Apogee Therapeutics, Inc., a clinical-stage biotechnology company, announced the first patient has been dosed in the Part B portion of the phase 2 APEX clinical trial of APG777 in patients with moderate-to-severe atopic dermatitis (AD), as well as enrollment completion in the Part A portion of the trial.

“Enrollment for the phase 2 Part A trial of APG777 surpassed the approximately 110 patient target ahead of schedule, driven by strong patient and investigator enthusiasm, underscoring the potential of APG777 to address the need for safe, effective treatment options that reduce injection burden and provide better disease control for patients with AD and other I&I conditions,” said Carl Dambkowski, M.D., chief medical officer of Apogee. “Positive results from our phase 1 healthy volunteer trial enabled us to design this phase 2 trial whereby APG777 is modeled to exceed lebrikizumab exposures by ~30-40% with potential for improved clinical responses, as well as approximately half the number of injections during induction and ~70-90% fewer injections in maintenance compared to currently available therapies. Our uniquely designed phase 2 trial allowed us to seamlessly transition from completing enrollment in Part A to enrolling Part B within one week, streamlining the clinical development process and potentially enabling us to bring APG777 to patients sooner.”

APEX is a phase 2 randomized, placebo-controlled clinical trial evaluating APG777, a novel, subcutaneous (SQ) extended half-life monoclonal antibody (mAb) targeting IL-13 – a critical cytokine in inflammation and a primary driver of AD, in patients with moderate-to-severe AD. The trial was designed to combine the typical phase 2a and 2b portions of a clinical trial into a single protocol. Part A exceeded expected enrollment with 123 patients randomized 2:1 to APG777 versus placebo; patients assigned to APG777 received induction regimen dosing of 720mg at weeks 0 and 2, followed by 360mg at weeks 4 and 12 and the trial has greater than 90% power for the primary endpoint. Patients benefiting from treatment will continue to APG777 maintenance dosing, which will evaluate 3- or 6-month dosing. Part B is a placebo-controlled dose optimization with approximately 280 patients randomized 1:1:1:1 to high, medium, or low dose APG777 versus placebo and the first patient in Part B have now been dosed. The primary endpoint of each part of the study is mean percentage change in EASI score from baseline at week 16. Secondary endpoints include EASI-75 and IGA 0/1 at week 16.

APG777 is currently in clinical development as a monotherapy for AD with several proof-of-concept anticipated readouts in 2025 and 2026, including Part A 16-week induction data in mid-2025 and maintenance data in the first half of 2026 as well as Part B 16-week data in the second half of 2026. Apogee plans to advance development of APG777 in expansion indications by initiating a phase 1b trial in asthma in the first half of 2025, followed by a Phase 2b trial in asthma in the second half of 2025, and launching a Phase 2 trial in EoE in 2026. In addition, Apogee plans to evaluate APG777 in combination with other investigational therapies within Apogee’s pipeline to potentially enable greater efficacy and improved safety for I&I conditions. Apogee plans to initiate its first combination study, a phase 1b trial of APG777 and APG990, a novel, SQ, half-life extended mAb targeting OX40L, in 2025. This combination study is designed to evaluate the safety, PK, PD and efficacy against Dupixent in patients with moderate-to-severe AD, with readout expected in the second half of 2026.

APG777 is a novel, subcutaneous half-life extended monoclonal antibody targeting IL-13 for the potential treatment of AD. In head-to-head preclinical studies, APG777 showed equivalent or better potency to lebrikizumab in the inhibition of IL-13 signaling. APG777 phase 1 trial data out to 12 months demonstrated a half-life of 77 days, a consistent safety and favourable PD profile showing near complete inhibition of pSTAT6 for up to 12 months after a single administration and sustained TARC inhibition. AD is a chronic inflammatory skin disorder with an estimated population of 82 million people worldwide afflicted with moderate-to-severe AD. Based on initial clinical data, the company plans to initiate a phase 1b and 2b trial in asthma, a phase 2 trial in EoE and plans to further evaluate opportunities to develop APG777 for other I&I indications, including alopecia areata, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, and prurigo nodularis.

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, COPD, EoE 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.

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