お知らせ • May 29
Apogee Therapeutics Announces Positive 16-Week Part B Induction Dose Optimization Results from Phase 2 Apex Trial of Zumilokibart in Moderate-To-Severe Atopic Dermatitis
Apogee Therapeutics announced positive 16-week data from Part B of the Phase 2 APEX clinical trial of zumilokibart (APG777), a potential best-in-class anti-IL-13 antibody, in patients with moderate-to-severe atopic dermatitis. The trial met its primary and secondary endpoints with high statistical significance including 65.9% of patients treated with mid-dose zumilokibart achieving EASI-75 (41.9% placebo adjusted). Based on these dose optimization results and subject to regulatory interactions, Apogee plans to move forward with the mid-dose, which achieved the best clinical activity of the three doses tested and was well-tolerated, in its Phase 3 trials. The APEX Phase 2 clinical trial is a randomized, placebo-controlled study evaluating zumilokibart in patients with moderate-to-severe atopic dermatitis. In Part B, 346 adult patients were dosed after being randomized 1:1:1:1 to high-, mid- or low-dose zumilokibart versus placebo. The primary endpoint is the proportion of patients who achieve an Eczema Area and Severity Index (EASI) percent score reduction of at least 75 (EASI-75) at Week 16. Secondary endpoints include Validated Investigator's Global Assessment (IGA) 0/1, EASI-90, Itch Numeric Rating Scale (I-NRS 4), EASI-100, and Very Low Disease Activity (vLDA; EASI-90 + I-NRS 0/1) at Week 16. The trial met its primary endpoint, with mid- and high-doses of zumilokibart demonstrating comparable efficacy and both doses outperforming low dose and placebo with EASI-75 scores at Week 16: High dose: 61.6% achieved EASI-75 (p<0.001 vs placebo), Mid dose: 65.9% achieved EASI-75 (p<0.001 vs placebo), Low dose: 50.5% achieved EASI-75 (p<0.001 vs placebo), Placebo: 23.4% achieved EASI-75. Mid-dose zumilokibart met key secondary endpoints at Week 16: IGA 0/1 response in 46.0% of patients, compared to 10.9% in the placebo arm (p<0.001), EASI-90 response in 47.4% of patients, compared to 9.3% in the placebo arm (p<0.001), I-NRS 4 reduction from baseline in 50.5% of patients, compared to 13.9% in placebo arm (p <0.001), EASI-100 response in 16.5% of patients, compared to 3.4% in the placebo arm (p<0.01), vLDA response in 20.6% of patients, compared to 4.5% in the placebo arm (p<0.01). Zumilokibart was well tolerated, with a safety profile generally consistent with other agents in the class. The most common treatment-emergent adverse events (TEAEs) in zumilokibart-treated patients were nasopharyngitis, headache, and noninfective conjunctivitis. For the planned Phase 3 dose (mid dose), the pooled conjunctivitis rate (all conjunctivitis preferred terms) was 10.6%, compared to 15.1% for the low dose and 20.7% for the high dose. Based on results from the APEX clinical program, Apogee plans to initiate Phase 3 trials of zumilokibart for moderate-to-severe atopic dermatitis in the second half of 2026, pending regulatory interactions. Apogee has also disclosed planned trial designs for its asthma and eosinophilic esophagitis (EoE) programs, further supporting zumilokibart's potential as a pipeline-in-a-product opportunity across multiple inflammatory and immunology diseases. The ADventure 1 and ADventure 2 trials are randomized, placebo-controlled, replicate Phase 3 monotherapy trials evaluating zumilokibart in patients with moderate-to-severe atopic dermatitis (EASI 16, vIGA 3, BSA 10%). Each study is expected to enroll approximately 400 patients and includes a 16-week induction period followed by maintenance through Week 52. In maintenance, patients will receive dosing every three or six months. The co-primary endpoint is EASI-75 and IGA 0/1 at Week 16, with additional assessment at Week 52. The ADventure TCS Phase 3 trial will evaluate zumilokibart in combination with background topical corticosteroids in patients with moderate-to-severe atopic dermatitis (EASI 16, vIGA 3, BSA 10%). The randomized, placebo-controlled study is expected to enroll approximately 400 patients and includes a 16-week induction period and maintenance through Week 52. The co-primary endpoint is EASI-75 and IGA 0/1 at Week 16, with longer-term outcomes assessed at Week 52. The ASPIRE Phase 2b trial is a randomized, placebo-controlled study evaluating multiple dosing regimens of zumilokibart in patients with moderate-to-severe asthma with elevated Type 2 biomarkers and a history of exacerbations. The study is designed to be potentially registrational and is expected to enroll approximately 500 patients randomized across dosing intervals of every three, six, or twelve months, or placebo. The primary endpoint is annualized exacerbation rate at Week 52, with additional assessments of lung function and symptoms. The ELEVATE Phase 2a trial is an open-label, proof-of-concept study evaluating zumilokibart in patients with eosinophilic esophagitis. The study is expected to enroll approximately 30 to 50 patients and will assess dosing every three or six months. The primary endpoint is histologic response, including reductions in eosinophil counts, with additional evaluation of endoscopic findings and patient-reported outcomes. The Company described expected program readouts and milestones through 2028. Initiation of Phase 3 ADventure 1 and ADventure 2 monotherapy (16-week) clinical trials expected second half of 2026. Initiation of Phase 3 ADventure TCS combination (16-week) clinical trial expected second half of 2026. Phase 2 APEX Part B (52-week) maintenance data expected first half of 2027. Phase 2 APEX Part A 2-year follow-up data expected second half of 2027. Phase 3 ADventure 1 and ADventure 2 monotherapy (16-week) data readout expected first half of 2028. Phase 3 ADventure TCS combination (16-week) data readout expected second half of 2028. Launch anticipated in 2029. Initiation of Phase 2b ASPIRE trial expected first half of 2027. Initiation of Phase 2a ELEVATE trial expected second half of 2026. Phase 2a ELEVATE data readout expected second half of 2027. Phase 2a ELEVATE long-term follow-up data expected second half of 2028. Phase 1b head-to-head clinical trial of APG279 (IL-13 + OX40L) vs. DUPIXENT for moderate to severe atopic dermatitis data readout expected second half of 2026. Announce further clinical plans for APG273 (zumilokibart+APG333) in second half of 2026. Announce additional pipeline program in first half of 2027. Zumilokibart (APG777) is a novel, subcutaneous extended half-life monoclonal antibody targeting IL-13 - a critical cytokine in inflammation and a primary driver of atopic dermatitis. In the APEX Phase 2 Part A 52-week trial, zumilokibart demonstrated potential to maintain and deepen clinical responses with as little as every 3- and 6-month dosing.
