zumilokibart (APG777) / Apogee Therap - LARVOL DELTA

Zumilokibart (APG777) Provides Early and Sustained Improvements in the Signs and Symptoms of Atopic Dermatitis: Results from the Phase 2 APEX Part A Study (AAD 2026) - No abstract available

Late-breaking abstract • P2 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Robust Efficacy of APG777 in Atopic Dermatitis Regardless of Baseline Disease Severity: Results from the Phase 2 APEX Part A Study (AAD 2026) - P2 | "Treatment with APG777 led to robust improvement in AD skin lesions over the 16-week induction period, regardless of baseline disease severity. These results support continued evaluation of APG777, including every 12- and 24-week maintenance dosing, in the ongoing phase 2 APEX study."

Clinical • P2 data • Atopic Dermatitis • Conjunctivitis • Dermatitis • Dermatology • Immunology • Infectious Disease • Ocular Infections • Ocular Inflammation • Ophthalmology • Respiratory Diseases • IL13

Improvement in Body Regions and Clinical Signs of Atopic Dermatitis with APG777: Results from the Phase 2 APEX Part A Study (AAD 2026) - P2 | "Treatment with APG777 during the 16-week induction period of APEX Part A led to statistically significant improvements in all signs of AD and across all body regions. These data support the continued evaluation of APG777 in phase 2 clinical trials."

Clinical • P2 data • Atopic Dermatitis • Conjunctivitis • Dermatitis • Dermatology • Immunology • Infectious Disease • Ocular Infections • Ocular Inflammation • Ophthalmology • Respiratory Diseases • IL13

Apogee Therapeutics Announces Positive Phase 2 Part A 52-Week Data of Zumilokibart (APG777), Demonstrating Maintenance and Deepening of Responses with Every 3- and 6-Month Dosing in Moderate-to-Severe Atopic Dermatitis (Apogee-biotech Press Release) - "Maintenance of Eczema Area and Severity Index percent score reductions of at least 75 (EASI-75) among Week 16 responder population by 75% and 85% of patients with every 3-month and 6-month dosing, respectively; Validated Investigator’s Global Assessment (vIGA) 0/1 maintenance of response of 86% for 3-month dosing and 78% for 6-month dosing among Week 16 responder population; Deepening of response was observed across all lesional and itch endpoints with every 3- and 6-month dosing; Well tolerated across the full 52-week study with a safety profile generally consistent with other agents in the class....Today’s data will also be presented in a late-breaking oral presentation at the 2026 American Academy of Dermatology Annual Meeting."

Late-breaking abstract • P2 data • Atopic Dermatitis

Biologic Monotherapies for Moderate-to-Severe Atopic Dermatitis: A Systematic Review and Bayesian Network Meta-Analysis of Established and Investigational Agents. (PubMed, Cureus) - "This Bayesian network meta‑analysis (BNMA) provides the first unified evaluation of all biologic monoclonal antibodies approved as monotherapy for AD (dupilumab, lebrikizumab, tralokinumab) together with emerging immunotherapies, including amlitelimab, rademikibart, rezpegaldesleukin, rocatinlimab, telazorlimab, temtokibart, and zumilokibart, across key efficacy measures.  A PRISMA‑2020-compliant systematic review and PROSPERO‑registered protocol (CRD420251162704) identified phase 2-3 randomized, double‑blind, placebo‑controlled trials reporting week‑16 outcomes (week‑24 for rocatinlimab). Zumilokibart, rademikibart, and temtokibart emerge as additional candidates with encouraging activity, whereas telazorlimab showed limited clinical benefit. Collectively, these findings provide a comprehensive comparative framework to inform biologic selection and therapeutic sequencing."

Journal • Retrospective data • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

An Active Comparator Safety Study Evaluating the Combination of APG777 + APG990 in Moderate-to-Severe Atopic Dermatitis (clinicaltrials.gov) - P1 | N=86 | Active, not recruiting | Sponsor: Apogee Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

APEX Part B is a placebo-controlled dose optimization trial with 347 patients randomized 1:1:1:1 to high-, medium- or low-dose zumilokibart versus placebo. (Apogee-biotech Press Release) - "Part B 16-week data are expected in the second quarter of 2026. Based on today’s results and anticipated Part B induction data, subject to clinical and regulatory outcomes, the company plans to begin Phase 3 trials of zumilokibart in the second half of 2026 enabling a potential launch in 2029."

Launch • New P3 trial • P2 data • Trial status • Atopic Dermatitis

Apogee Therapeutics to Host Conference Call to Report Part A 52-Week Data from the Phase 2 APEX Trial of Zumilokibart (APG777) in Patients with Moderate-to-Severe Atopic Dermatitis on March 23, 2026 (GlobeNewswire)

P2 data • Atopic Dermatitis

Apogee Therapeutics Provides Pipeline Progress… (GlobeNewswire) - "Zumilokibart (APG777) trials continue to advance in atopic dermatitis (AD) with plans for expansion indications underway: APEX Phase 2 Part A 52-week data expected this month; APEX Phase 2 Part B 16-week data expected in Q2 2026; Phase 3 trial initiation in AD anticipated in 2H 2026; Successful expansion of zumilokibart beyond AD demonstrated in asthma Phase 1b trial; details on asthma and eosinophilic esophagitis (EoE) trials expected later this year."

New P3 trial • P1 data • P2 data • Asthma • Atopic Dermatitis • Eosinophilic Esophagitis

Efficacy of APG777 in Patients with Atopic Dermatitis and Evidence of Type 2 Inflammatory Comorbidities: Results from the Phase 2 APEX Study (AAAAI 2026) - P2 | "No new safety signals were detected in patients with or without asthma and sinonasal conditions. Conclusions Treatment with APG777 was well-tolerated and provided clinically meaningful improvements in AD signs and symptoms, regardless of coexisting type 2 inflammatory conditions."

Clinical • Late-breaking abstract • P2 data • Asthma • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Respiratory Diseases • IL13

Rapid Improvement in Skin, Itch, and Sleep: Physician- and Patient-Reported Outcomes from the Phase 2 APEX Study of APG777 in Atopic Dermatitis (AAAAI 2026) - P2 | "Conclusions Treatment with APG777 led to rapid and sustained improvement in AD skin lesions, itch, and sleep, while reducing injection burden for patients with only 4 dosing days through Week 16. These results support evaluation of every 12- and 24-week maintenance dosing in the ongoing APEX study."

Clinical • P2 data • Patient reported outcomes • Atopic Dermatitis • CNS Disorders • Dermatitis • Dermatology • Immunology • Inflammation • Sleep Disorder • IL13

Phase 1b head-to-head trial of APG279 (zumilokibart + APG990) vs. DUPIXENT underway, with interim AD data anticipated in 2H 2026 (GlobeNewswire)

P1 data • Atopic Dermatitis

Early and Sustained Suppression of FeNo With a Single Dose of Zumilokibart (APG777), a Novel Half-Life-Extended Anti-Il-13 Antibody, in Patients With Mild-to-Moderate Asthma (ATS 2026) - No abstract available

Clinical • Late-breaking abstract • Asthma • Immunology • Respiratory Diseases • IL13

APG777-202: A Study to Evaluate the Long-term Safety and Effectiveness of APG777 in Subjects with Atopic Dermatitis (clinicaltrialsregister.eu) - P1/2 | N=175 | Recruiting | Sponsor: Apogee Therapeutics Inc.

New P1/2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

The novel therapy APG777 may reduce injection burden and lead to rapid and sustained improvement in pruritus, skin lesions, and sleep for patients with moderate to severe atopic dermatitis (AD), according to study findings presented at the American Academy of Allergy, Asthma & Immunology Annual Meeting held from February 27 to March 2, 2026, in Philadelphia, PA. (Dermatology Advisor) - "As early as day 3, significant improvement in pruritus was noted in I-NRS scores, with a mean change from baseline of -18.1% for the APG777 group vs -4.2% for the placebo group (P <.01). Through week 16, mean change from baseline improved to -50.7% vs -23.2%, respectively (P =.001). By week 1, APG777 was associated with pruritus-related sleep disturbance improvements. From baseline to week 2, significantly greater reductions in the mean change of EASI scores were noted with APG777 vs placebo (-35.4% vs -20.8%; P =.01)."

P2 data • Atopic Dermatitis

Apogee Therapeutics…Highlights 2026 Anticipated Milestones and Outlook (GlobeNewswire) - "Phase 2 APEX Part A (52-week) maintenance data readout – expected Q1 2026; Phase 2 APEX Part B (16-week) induction data readout – expected Q2 2026: The trial completed enrollment ahead of schedule and exceeded its target with a total of 347 patients, driven by strong interest from physicians and patients. Initiation of Phase 3 trial – expected 2H 2026 enabling potential launch in 2029."

Enrollment closed • Launch • New P3 trial • P2 data • Atopic Dermatitis

Apogee Therapeutics Announces Positive Interim Results from Phase 1b Trial of Zumilokibart (APG777), its Potentially Best-in-Class Anti-IL-13 Antibody, in Patients with Mild-to-Moderate Asthma… (GlobeNewswire) - "Robust and durable suppression of FeNO, a biomarker of Type 2 inflammation that has shown the strongest correlation with exacerbations in asthma, following a single dose. Maximum absolute mean FeNO reduction of 45 ppb (60% decrease from baseline) after single dose. Durable FeNO suppression through 16 weeks for all patients. Suppression of FeNO through 32 weeks for patients with available follow up, supporting potential for 3- or 6-month dosing."

P1 data • Asthma • Immunology

A First-in-Human, Single- and Multiple-Dose Study of APG777, a Half-Life-Extended Anti-IL-13 Monoclonal Antibody, in Healthy Volunteers. (PubMed, Clin Transl Sci) - "APG777 led to rapid and durable inhibition of the IL-13-driven biomarkers phosphorylated signal transducer and activator of transcription 6 (pSTAT6), thymus and activation-regulated chemokine (TARC), and immunoglobulin E (IgE), with near-complete suppression of pSTAT6 observed for up to 12 months post-dose. The safety and optimized pharmacokinetic profile of APG777 supports evaluation of extended dosing intervals (every 3-6 months) and higher exposures, which could improve outcomes and reduce injection burden in patients with Type 2 inflammatory diseases including atopic dermatitis and asthma."

Clinical • First-in-human • Journal • P1 data • Asthma • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • IL13 • STAT6

An Active Comparator Safety Study Evaluating the Combination of APG777 + APG990 in Moderate-to-Severe Atopic Dermatitis (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Apogee Therapeutics, Inc. | N=50 ➔ 80

Enrollment change • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study Evaluating APG777 in Atopic Dermatitis (clinicaltrials.gov) - P2 | N=470 | Active, not recruiting | Sponsor: Apogee Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Preclinical development of an anti-IL-13 antibody for the treatment of atopic dermatitis (ISDS 2025) - "Type 2 inflammatory pathway antagonism is safe and effective in the treatment of atopic dermatitis, with multiple approved drugs targeting the cytokine IL-13 (Ebglyss, Adbry) or its receptor IL-4R (Dupixent), and other IL-13 antagonists showing success in clinical development with half-life extended molecules (APG777). These molecules demonstrate pM IL-13 affinity, efficient antagonism of IL-13 signaling in both reporter cell lines and primary keratinocytes, extended half-life properties, and manufacturability and stability profiles consistent with commercially validated therapeutics. These candidates open the door to synergistic combinations pairing IL-13 antagonism with complementary pathway inhibition, for the treatment of inflammatory diseases like atopic dermatitis, particularly addressing patients whose disease remains inadequately controlled by existing systemic therapies."

Preclinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • IL13 • IL4R

Rationale and Design of a Phase-1b Trial Evaluating APG279, the Combination of Half-Life-Extended Anti-IL-13 and Anti-OX40L Monoclonal Antibodies, Compared With Dupilumab in Moderate-to-Severe Atopic Dermatitis (ISDS 2025) - P1 | "Rationale: APG279 is a combination of APG777, a half-life-extended anti-IL-13 mAb, and APG990, a half-life-extended anti-OX40L mAb. Exploratory endpoints include biomarkers, ADA, and efficacy (e.g., EASI-75, vIGA-0/1) throughout the study including the follow-up period. The study is currently enrolling in Canada, Australia, and New Zealand and aims to include ∼50 participants."

IO biomarker • P1 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • IL13 • IL4 • TNFSF4

APG777, a half-life-extended mAb targeting IL-13, demonstrates rapid and sustained inhibition of serum TARC levels in patients with moderate to severe atopic dermatitis (ISDS 2025) - P2 | "The rapid and sustained pharmacodynamic effects of APG777 on TARC levels, including correlation of this biomarker with change in EASI, and the normalization of TARC levels through Week 16, suggest a meaningful modulation of IL-13 signaling by APG777. These data support the mechanistic rationale of APG777 as a potent inhibitor of IL-13, a pathogenic driver in AD."

Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • IL13

APEX: An integrated phase 2 program evaluating APG777, a half-life extended anti-IL-13 monoclonal antibody, in atopic dermatitis (ISDS 2025) - P2 | "APEX is an integrated phase 2 program, including both proof of concept (Part A) and dose optimization (Part B), that is evaluating the efficacy and safety of APG777 in adults with moderate-to-severe AD."

P2 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • IL13

A Combination of APG777 (anti-IL-13) and APG990 (anti-OX40L) Improves Inflammatory and Barrier Disruption Pathologies of Atopic Dermatitis (ISDS 2025) - "These data indicate that the combination of APG777+APG990 is more effective than single agents in broadening the suppression of Type 1, 2, and 3 inflammation, while also inhibiting skin barrier remodeling—both of which are important pathologies of AD. The combination of APG777+APG990 has the potential to address a wide range of AD pathologies and is currently being evaluated in a Phase 1b clinical study."

Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • CD4 • IL13 • POSTN • TNFSF4 • TSLP