APG777 / Apogee Therap - LARVOL DELTA

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

APG777, a Novel, Half-Life Extended Anti-IL-13 Antibody, Demonstrates Safety and Efficacy in Moderate-to-Severe Atopic Dermatitis: 16-Week Results From the Phase 2 APEX Study (ISDS 2025) - P2 | "Treatment with APG777 over 4 dosing days during the 16-week induction period was effective and well-tolerated in adults with moderate-to-severe AD. These results support evaluation of every 12- or 24-week dosing in the maintenance portion of APEX Part-A, while the observed exposure-response relationship supports evaluation of higher APG777 doses in APEX Part-B."

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

Completed $345 million public offering (GlobeNewswire) - "In October, Apogee completed an underwritten public equity offering, with aggregate gross proceeds of approximately $345.0 million (before deducting underwriting discounts, commissions, and other offering expenses) which supports cash runway into the second half 2028 and through APG777 Phase 3 topline data."

Financing • Atopic Dermatitis

Corporate & Pipeline Highlights and Upcoming Milestones (GlobeNewswire) - "APG777 continues to advance and has accelerated readout guidance with Phase 1b data in asthma, AD data from APEX 52-week Part A anticipated in Q1 2026, and APEX 16-week Part B data in Q2 2026....Pending results from Part A and Part B, the company plans to begin Phase 3 trials of APG777 in the second half of 2026."

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

APG777, a Novel, Half-Life Extended Anti-IL-13 Antibody, Demonstrates Safety and Efficacy in Moderate-to-Severe Atopic Dermatitis: 16-Week Results From the Phase 2 APEX Study (EADV 2025) - P2 | "Conclusion Treatment with APG777 over 4 dosing days during the 16-week induction period led to significant improvement in the signs and symptoms of AD and was well-tolerated. Primary results of this phase 2 trial support further evaluation of every 12- or every 24-week dosing in the maintenance portion of APEX Part A, while the demonstration of an exposure-response relationship supports evaluation of higher doses of APG777 in APEX Part B."

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

The Combination of APG777 (anti-IL-13) and APG990 (anti-OX40L) Provides Broad Suppression of Inflammatory Cytokines (EADV 2025) - "These data suggest that the combination of APG777+APG990 is a promising approach for the treatment of chronic inflammatory disease."

IO biomarker • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Respiratory Diseases • CD4 • IL13 • TNFSF4 • TSLP

APEX: An integrated phase 2 program evaluating APG777, a half-life extended anti-IL-13 monoclonal antibody, in atopic dermatitis (EADV 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

In vitro potency and pharmacokinetics of APG777, a novel anti-IL-13 mAb. (PubMed, J Allergy Clin Immunol Glob) - "All studies included lebrikizumab produced based on the publicly available sequence as key comparator. The prolonged half-life of APG777 may enable less frequent dosing compared with current treatments, which could reduce injection burden and increase compliance. APG777 is currently being investigated in a phase 2 randomized, controlled trial in patients with atopic dermatitis."

Journal • PK/PD data • Preclinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • IL13 • STAT6

Apogee Therapeutics Announces Late-Breaker Presentation of 16-Week Data from Phase 2 APEX Trial of APG777 for Moderate-to-Severe Atopic Dermatitis at the Upcoming European Academy of Dermatology and Venereology (EADV) 2025 Congress (GlobeNewswire) - "The Company will also present multiple poster presentations....previously reported healthy volunteer data of APG990.'"

Clinical data • Late-breaking abstract • Atopic Dermatitis

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Immunogenicity of APG777 in Adults With Asthma (clinicaltrials.gov) - P1 | N=31 | Active, not recruiting | Sponsor: Apogee Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Preclinical Safety of APG777, A Novel Extended Half-Life Anti-Interleukin-13 Monoclonal Antibody, in Cynomolgus Monkeys. (PubMed, Int J Toxicol) - P2 | "The extended half-life of APG777 suggests potential benefits in reducing dosing frequency compared with existing IL-13-targeting therapies, which could improve treatment adherence and patient outcomes. The safety and efficacy of APG777 are currently being investigated in a Phase 2 clinical trial (NCT06395948) in patients with moderate-to-severe atopic dermatitis."

Journal • Preclinical • Asthma • Atopic Dermatitis • Dermatitis • Dermatology • Hematological Disorders • Immunology • Inflammation • Ophthalmology • Pulmonary Disease • Respiratory Diseases • IL13

Apogee Therapeutics Announces Positive 16-Week Data from Phase 2 APEX Clinical Trial of APG777, its Potentially Best-in-Class Anti-IL-13 Antibody, in Moderate-to-Severe Atopic Dermatitis (GlobeNewswire) - P2 | N=391 | APEX (NCT06395948) | Sponsor: Apogee Therapeutics, Inc. | "The trial met its primary endpoint, with APG777 showing significantly greater least squares mean percent change from baseline at Week 16 with an EASI reduction of 71.0% compared to placebo of 33.8% (p < 0.001); Highest absolute and placebo-adjusted EASI-75 of any biologic with 66.9% of participants treated with APG777 achieving EASI-75 compared to 24.6% on placebo (p < 0.001); APG777 was well tolerated with a safety profile consistent with other agents in the class...APEX 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. Part B continues to enroll participants with readout expected in mid-2026. Data readout from the maintenance phase of APEX Part A, testing 3- and 6-month maintenance dosing, is expected in the first half of 2026."

P2 data • Atopic Dermatitis

Continued progress for APG777 in expanded indications expected in 2025 and 2026 (GlobeNewswire) - "The Phase 1b trial of APG777 in patients with mild-to-moderate asthma is ongoing, with readout expected in the first half of 2026....Apogee plans to conduct Phase 2b trials in asthma and eosinophilic esophagitis (EoE) with trial designs informed by APEX Part B dose optimization as well as the Phase 1b results in asthma. Apogee expects to announce plans for these Phase 2b trials in 2026."

New P2b trial • P1 data • Asthma • Eosinophilic Esophagitis

Phase 2 APEX trial (GlobeNewswire) - "52-week data from APEX Part A is expected in the first half of 2026....Enrollment has remained strong in this global trial, and the 16-week Part B readout has been accelerated to mid-2026. Pending results from Part A maintenance, Part B induction data and regulatory feedback, the company plans to initiate Phase 3 trials of APG777 in 2026."

New P3 trial • P2 data • Atopic Dermatitis

Apogee Therapeutics Provides Business Update, Pipeline Progress and Reports First Quarter 2025 Financial Results (GlobeNewswire) - "The Phase 2 APEX clinical trial of APG777 is progressing, with Part A fully enrolled and Part B actively enrolling patients with moderate-to-severe AD. The company expects to report 16-week topline data from Part A of the trial in mid-2025 and from Part B in the second half of 2026. Apogee today announced that the first patient has been dosed in a Phase 1b trial of APG777 in patients with mild-to-moderate asthma. The primary endpoint of the trial is safety and tolerability, with secondary endpoints exploring pharmacokinetics (PK), FeNO suppression of APG777, with readout expected in the first half of 2026."

P1 data • P2 data • Trial status • Asthma • Atopic Dermatitis

Apogee Therapeutics to Host Conference Call to Report Part A 16-Week Data from the Phase 2 APEX Trial of APG777 in Patients with Moderate-to-Severe Atopic Dermatitis on July 7, 2025 (GlobeNewswire) - "Apogee Therapeutics, Inc...announced it will report Part A 16-week data from the Phase 2 APEX trial of APG777 on Monday, July 7, 2025. Following the announcement, the Company will host a conference call and webcast at 8:00 a.m. ET to discuss the results."

P2 data • Atopic Dermatitis

Therapeutic Pipeline (CDA 2025) - "New therapeutics in AD (OX40, Nemolizumab, Delgocitinib, and APG777) 2. New therapeutics in PN (Ruxolitinib) 3. New therapeutics in PsO (Icotrokinra) 4. New therapeutics in HS (Bimekizumab) 5. New therapeutics in CSU (Dupilumab)"

Dermatology

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

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

A Long-term Safety and Efficacy Study Evaluating APG777 in Atopic Dermatitis (clinicaltrials.gov) - P2 | N=350 | Recruiting | Sponsor: Apogee Therapeutics, Inc.

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

The Combination of APG777 (anti-IL-13) and APG333 (anti-TSLP) Inhibits Central and Local Drivers of Obstructive Airway Disease (ATS 2025) - "Benchmark mAbs dupilumab (anti-IL-4Rα), lebrikizumab (anti-IL-13), and tezepelumab (anti-TSLP) were produced based on publicly available sequences. Consistent with TSLP and IL-13 having distinct roles in mediating obstructive airway disease pathology, administration of APG777+APG333 provided potent and broad inhibition of biomarkers of central inflammation and local airway response in primary human cells. Effects were greater and broader than those observed with benchmarks, suggesting that targeting orthogonal drivers of obstructive airway disease is a promising approach for the treatment of Th2-driven respiratory diseases. These data support the continued development of APG777+APG333 for Th2-driven inflammatory diseases."

Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Respiratory Diseases • CCL11 • CD4 • CRLF2 • IL13 • IL5 • IL6 • POSTN

A First-in-human Study of APG777 in Healthy Participants (ANZCTR) - P1 | N=40 | Completed | Sponsor: Apogee Therapeutics, Inc | Active, not recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology