APG777 / Apogee Therap - LARVOL DELTA

APEX: An integrated phase 2 program evaluating APG777, a half-life extended anti-IL-13 monoclonal antibody, in atopic dermatitis (EADV 2025) - No abstract available

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

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

The Combination of APG777 (anti-IL-13) and APG990 (anti-OX40L) Provides Broad Suppression of Inflammatory Cytokines (EADV 2025) - No abstract available

IL13 • TNFSF4

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

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Immunogenicity of APG777 in Adults With Asthma (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Apogee Therapeutics, Inc.

New P1 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Apogee Therapeutics Provides Pipeline Progress and Reports Full Year 2024 Financial Results (GlobeNewswire) - "Apogee plans to initiate a...Phase 2b trial in asthma in the second half of 2025 with data expected in 2026...A Phase 1 trial of APG333 in healthy volunteers is underway, with data expected in the second half of 2025. Apogee plans to evaluate APG777 and APG333 monotherapies in respective Phase 1b trials in patients with asthma in 2025 to support advancement into future combination trials in asthma and COPD...Apogee is also evaluating APG808 in a Phase 1b trial in patients with asthma, with data expected in the first half of 2025."

New P1 trial • New P2b trial • P1 data • P2b data • Asthma • Immunology • Respiratory Diseases

The Combination of APG777 (Anti-IL-13) and APG990 (Anti-OX40L) Provides Broad Suppression of Inflammatory Cytokines (AAD 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 Announces Positive Interim Phase 1 Results from the APG990 Healthy Volunteer Trial, Unlocking Potential Maintenance Dosing Every Three and Six Months for APG279 (APG777 + APG990) (GlobeNewswire) - P1 | N=40 | ACTRN12624000775516 | Sponsor: Apogee Therapeutics, Inc. | Apogee Therapeutics, Inc...today announced positive interim Phase 1 results from its first-in-human trial of APG990...APG990 demonstrated a potential best-in-class PK profile, including a half-life of approximately 60 days, supporting the potential for every three- and six-month maintenance dosing. PK profile supports the potential for a single 2 mL coformulated injection of APG279 (APG777 + APG990) administered every three- and six- months. APG990 was well tolerated across all five cohorts, with doses up to 1,200mg. The most common (≥10%) treatment-emergent adverse events (TEAEs) were headache. 53% of participants observed at least one TEAE. There were no Grade 3 TEAEs related to study drug or severe adverse events. No adverse events led to study discontinuation. There have been no cases of pyrexia or chills."

P1 data • Atopic Dermatitis • Immunology

Apogee Therapeutics to Host Conference Call to Report Interim Results from the Phase 1 Healthy Volunteer Trial for APG990 and Provide Combination Strategy Update on March 3, 2025 (GlobeNewswire) - "Apogee Therapeutics...announced it will report interim results from the Phase 1 APG990 healthy volunteer trial on Monday, March 3, 2025. Following the announcement, the Company will host a conference call and webcast at 8:30am ET to discuss the results and plans for its combination approach for APG777 + APG990."

P1 data • Pipeline update • Immunology

The Combination of APG777 (anti-IL-13) and APG333 (anti-TSLP) Improves Type 2 Inflammatory Suppression Compared to Single Agents (AAAAI-WAO 2025) - "Dupilumab and tezepelumab controls were produced based on publicly available sequences. Conclusions The combination of APG777+APG333 mediates greater suppression of Th2 immune response markers compared with both single-agent controls and benchmarks. These data support continued development of APG777+APG333 for Th2-driven inflammatory diseases."

Inflammation • CRLF2 • IL13 • TSLP

Apogee plans to advance development of APG777 in expansion indications… (GlobeNewswire) - "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...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."

New P1 trial • New P2 trial • New P2b trial • P1 data • Asthma • Atopic Dermatitis • Eosinophilic Esophagitis

Apogee Therapeutics Announces First Patient Dosed in Part B of Phase 2 APEX Trial of APG777 in Patients with Moderate-to-Severe Atopic Dermatitis (GlobeNewswire) - "Apogee Therapeutics, Inc...today 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 AD, as well as enrollment completion in the Part A portion of the trial...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."

Clinical data • P2a data • P2b data • Trial status • Atopic Dermatitis

Apogee Therapeutics Highlights Progress and Best-in-Class Potential of Novel Biologic Programs for I&I Diseases at 2024 Inaugural R&D Day (GlobeNewswire) - P1 | N=32 | "Apogee Therapeutics, Inc...Updates include positive interim results from the APG808 Phase 1 trial, data up to 12 months from the APG777 Phase 1 trial, details around the Company’s strategy for combinations in AD, asthma and COPD to deliver better efficacy and dosing regimens, and the expected significant commercial potential of its programs....APG808 demonstrated a potential best-in-class PK profile, including a half-life of approximately 55 days, supporting the potential for every 2- to 3- month maintenance dosing. Single doses of APG808 demonstrated a deep and sustained effect on pharmacodynamic (PD) markers out to ~3 months (longest follow-up available at time of data cut). APG808 was well tolerated across all dose groups. Apogee is also now evaluating APG808 in a Phase 1b trial in patients with asthma, with data expected in the first half of 2025."

P1 data • Pipeline update • Asthma • Atopic Dermatitis • Immunology

APG777, ANTI-IL-13 MONOCLONAL ANTIBODY, DEMONSTRATES EXTENDED HALF-LIFE AND SUSTAINED INHIBITION OF TYPE 2 INFLAMMATORY BIOMARKERS (ACAAI 2024) - P2 | "The favorable safety profile, optimized PK, and prolonged inhibition of key biomarkers of type 2 inflammation support the initiation of phase 2 studies of APG777 in adults with moderateto-severe atopic dermatitis (NCT06395948) and adults with moderate-to-severe asthma, where every 3- to 6-month maintenance dosing will be evaluated."

Biomarker • Asthma • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Respiratory Diseases • IL13 • IL4R • STAT6

Apogee Therapeutics Announces Poster Presentation at the ACAAI 2024 Annual Scientific Meeting (GlobeNewswire) - "Apogee Therapeutics...announced an upcoming poster presentation at the American College of Allergy, Asthma & Immunology’s (ACAAI) 2024 Annual Scientific Meeting, held in Boston from October 24-28, 2024. The company plans to present data up to 9 months from the ongoing Phase 1 clinical trial of APG777, a novel half-life extended anti-IL-13 antibody for the treatment for atopic dermatitis and other inflammatory diseases."

P1 data • Atopic Dermatitis

Apogee Therapeutics Announces First Participants Dosed in Phase 1 Clinical Trial of APG990, its Novel Half-Life Extended OX40L Antibody for the Treatment of Atopic Dermatitis and Other Inflammatory Diseases (GlobeNewswire) - "Apogee Therapeutics...announced that it has initiated dosing of healthy volunteers in its first clinical trial for APG990, a novel, subcutaneous (SQ) half-life extended monoclonal antibody targeting OX40L, which is being developed initially as a treatment for people living with AD....The APG990 Phase 1 clinical trial is designed as a double-blind, placebo-controlled, first-in-human, single-ascending dose trial in healthy volunteers. The study will evaluate the safety, tolerability and pharmacokinetics (PK) of APG990 and is expected to enroll approximately 40 healthy adults into 5 cohorts. Apogee expects interim data from the trial in 2025....The company plans to initiate the first clinical trial of the APG777 and APG990 combination in 2025."

New trial • P1 data • Trial status • Atopic Dermatitis • Inflammation