APG-279 / Apogee Therap - LARVOL DELTA

The Role of OX40 Pathway Inhibition as a New Therapeutic Strategy for Atopic Dermatitis. (PubMed, BioDrugs) - "Amlitelimab, an anti-OX40L monoclonal antibody, has demonstrated sustained efficacy and a favorable safety profile in phase IIa and IIb trials. Rocatinlimab, targeting OX40, has also shown promising results in a phase IIb study and has progressed into multiple phase III trials, with supportive top-line data. In contrast, telazorlimab has shown more modest efficacy and has not advanced to later-stage development. Next-generation agents, including IMG-007, STAR-0310, APG990, and APG279, have been engineered with extended half-lives and attenuated antibody-dependent cellular cytotoxicity to support longer dosing intervals and improve tolerability. While these findings are encouraging, direct comparative studies among agents and versus established therapies are lacking, and long-term efficacy and safety data are still needed. This narrative review explores the role of the OX40/OX40L axis in atopic dermatitis pathogenesis and critically evaluates emerging therapies targeting..."

Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • TNFSF4

Serial innovation in AD advances with APG279 Phase 1b expanded to approximately 80 patients with readout on track for 2H 2026 based on strong enrollment (GlobeNewswire)

P1 data • Atopic Dermatitis

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

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

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

Interim readout from the head-to-head trial evaluating the safety, PK, pharmacodynamics and efficacy of APG279 vs. DUPIXENT in AD is expected in the second half of 2026. (GlobeNewswire)

P1 data • Atopic Dermatitis

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

Apogee Therapeutics Provides Pipeline Progress and Reports Second Quarter 2025 Financial Results (GlobeNewswire) - "In July 2025, Apogee announced that the first patient was dosed in its first-in-class combination trial, a Phase 1b study designed to evaluate safety, PK, pharmacodynamics and efficacy of APG279 vs. DUPIXENT in patients with moderate-to-severe AD. Readout is expected in the second half of 2026."

P1 data • Trial status • Atopic Dermatitis

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

Apogee Therapeutics Provides Business Update, Pipeline Progress and Reports First Quarter 2025 Financial Results (GlobeNewswire) - "Apogee plans to initiate its first-in-class combination trial, a Phase 1b trial designed to evaluate the safety, PK, pharmacodynamics and efficacy of APG279 against DUPIXENT in patients with moderate-to-severe AD this year, with an interim readout expected in the second half of 2026."

New P2 trial • Atopic Dermatitis