APG777 / Apogee Therap - LARVOL DELTA

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

The Combination of APG777 (anti-IL-13) and APG333 (anti-TSLP) Inhibits Central and Local Drivers of Obstructive Airway Disease (ATS 2025) - No abstract available

Respiratory Diseases • IL13

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

Extended Half-life Antibodies: A Narrative Review of a New Approach in the Management of Atopic Dermatitis. (PubMed, Dermatol Ther (Heidelb)) - "APG777, targeting interleukin-13 (IL-13), and IMG-007, targeting OX40 receptor, have shown promising preclinical and early clinical results...As research continues, extended half-life antibodies could significantly improve AD management and patient quality of life. Further studies will determine the long-term safety and efficacy of extended half-life antibodies, with ongoing innovations in antibody engineering likely to broaden their applications and benefits."

Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immune Modulation • Immunology • Inflammation • Pruritus • IL13

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

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Apogee Announces Dosing of First Patient in Phase 2 Atopic Dermatitis Trial of APG777, a Novel Subcutaneous Half-life Extended Anti-IL-13 Antibody for the Treatment of Atopic Dermatitis and Other Inflammatory Diseases (GlobeNewswire) - "Apogee Therapeutics...announced that it has initiated dosing in the Phase 2 trial of APG777 in patients with moderate-to-severe atopic dermatitis....The APG777 Phase 2 clinical trial is a randomized, placebo-controlled, 16-week trial in patients with moderate-to-severe AD....16-week proof-of-concept data from Part A of the Phase 2 trial expected in 2H 2025."

P2 data • Trial status • Atopic Dermatitis

A Study Evaluating APG777 in Atopic Dermatitis (clinicaltrials.gov) - P2 | N=471 | Recruiting | Sponsor: Apogee Therapeutics, Inc.

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

APG777, a high-affinity humanized IgG1 monoclonal antibody targeting IL-13, demonstrates prolonged half-life and pSTAT6 inhibition in non-human primates (SID 2024) - No abstract available

IL13

Prolonged half-life and sustained inhibition of key inflammatory biomarkers: a phase 1 study of APG777, a high-affinity humanized IgG1 monoclonal antibody targeting IL-13 (SID 2024) - No abstract available

Biomarker • Late-breaking abstract • P1 data • IL13

Apogee Announces Positive Interim Results from Phase 1 Healthy Volunteer Trial for APG777, its Novel Half-Life Extended Anti-IL-13 Antibody for the Treatment for Atopic Dermatitis and Other Inflammatory Diseases, Exceeding its Trial Objectives Ahead of Schedule with Half-Life of Approximately 75 Days (GlobeNewswire) - P1 | N=NA | "Apogee Therapeutics, Inc...today announced positive interim Phase 1 data from its first-in-human study of APG777, one of its lead product candidates being developed as a frontline treatment for moderate-to-severe AD and other inflammatory diseases. Pharmacokinetic (PK) data showed a half-life of approximately 75 days across doses tested and Pharmacodynamic (PD) data showed deep and sustained inhibition of key AD biomarkers pSTAT6 and TARC for ~3 months (longest follow-up available, with inhibition still ongoing at time of the data cut). Results from the trial exceeded the Company’s trial objectives and support the potential for APG777....Based on these data, the company plans to initiate a randomized, placebo-controlled, Phase 2 clinical trial in patients with moderate-to-severe AD in the first half of 2024 ahead of schedule."

P1 data • Atopic Dermatitis • Immunology

Apogee to Host Conference Call and Webcast to Report Interim Results from Phase 1 Healthy Volunteer Trial for APG777, its Novel Half-Life Extended Anti-IL-13 Antibody for the Treatment for Atopic Dermatitis and Other Inflammatory Diseases on March 5, 2024 (Yahoo Finance) - "Apogee Therapeutics, Inc...today announced it will report interim results from the Phase 1 APG777 healthy volunteer trial on Tuesday, March 5, 2024. Following the announcement, the Company will host a conference call and webcast at 7:00am ET to discuss the results."

P1 data • Atopic Dermatitis • Immunology

Apogee Highlights Corporate Progress and Reports Third Quarter 2023 Financial Results (GlobeNewswire) - "Apogee believes this potential for significant differentiation compared to leading therapies may contribute to a best-in-class profile for APG777. Pending positive PK and safety data, the company plans to advance into a randomized, double-blind, placebo-controlled, 16-week Phase 2 proof-of-concept trial in moderate-to-severe patients with AD in 2024 with data expected in the second half of 2025. Finalized nomination of APG808 development candidate in 4Q 2023: APG808...has demonstrated similar inhibition to DUPIXENT across three in vitro assays which measure downstream functional inhibition of the IL-13/IL-4 pathway....Additionally, in Apogee’s head-to-head studies of APG808 and DUPIXENT in non-human primates, APG808 showed a significantly longer half-life than DUPIXENT. In these preclinical studies, APG808’s half-life was up to 26 days, as compared to 12 days for DUPIXENT."

New P2 trial • P2 data • Preclinical • Atopic Dermatitis • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease

APG777, a high-affinity humanized IgG1 mAb targeting IL-13, demonstrates prolonged half-life in non-human primates (EADV 2023) - "APG777 demonstrated a substantial increase in half-life compared to lebrikizumab in NHPs. APG777 was engineered to have this extended half-life, due to the YTE amino acid substitutions in the Fc region of APG777, which have been shown to prolong the half-life of IgGs by increasing binding to FcRn under acidic pH conditions. FcRn-bound IgG is recycled via lysosomal salvage, resulting in the IgG returning to the circulation."

Asthma • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pulmonary Disease • Respiratory Diseases • IL13

A First-in-human Study of APG777 in Healthy Participants (ANZCTR) - P1 | N=40 | Recruiting | Sponsor: Apogee Biologics, Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Trial initiation date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology