APG808 / Apogee Therap - LARVOL DELTA

Apogee Therapeutics Announces Positive Interim Results from the Phase 1b Trial of APG808, its Novel Half-life Extended IL-4Rα Antibody, in Patients with Mild-to-Moderate Asthma (GlobeNewswire) - P1b | N=52 | ACTRN12624000238572 | Sponsor: Apogee Therapeutics, Inc. | "Apogee Therapeutics, Inc...announced positive interim data from its Phase 1b trial of APG808, a novel half-life extended IL-4Rα antibody, in patients with mild-to-moderate asthma....Multiple doses of APG808 resulted in rapid suppression of FeNO, a biomarker of Type 2 inflammation that is associated with exacerbations in asthma, with a maximal robust FeNO decrease from baseline of 53% and sustained FeNO decrease from baseline of 50% at 12 weeks. APG808 also demonstrated sustained and near-complete reduction in pSTAT6 as well as deep reduction of TARC maintained through 12 weeks, two key Type 2 inflammatory biomarkers. APG808's optimized formulation and potential best-in-class PK profile along with durable FeNO suppression out to 12-weeks support potential for 2-month or longer maintenance dosing."

P1 data • Asthma

A First-in-human Study of APG808 in Healthy Participants and in Patients With Mild-to-moderate Asthma (ANZCTR) - P1 | N=52 | Active, not recruiting | Sponsor: Apogee Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • 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

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

A First-in-human Study of APG808 in Healthy Participants and in Patients With Mild-to-moderate Asthma (ANZCTR) - P1 | N=52 | Recruiting | Sponsor: Apogee Therapeutics, Inc. | Not yet recruiting ➔ Recruiting | N=32 ➔ 52 | Initiation date: Mar 2024

Enrollment change • Enrollment open • Trial initiation date • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

APG808, A High-Affinity Fully Human IgG1 Monoclonal Antibody Targeting IL-4Rα, Demonstrates Prolonged Half-Life in Non-Human Primates (ATS 2024) - "APG808 demonstrated an increase in half-life compared with dupilumab in NHPs. APG808's prolonged half-life may enable less frequent dosing compared with currently available treatments, which could reduce injection burden and increase compliance for patients living with COPD and other type 2 inflammatory diseases. These data support the initiation of a Phase 1 study of APG808 in healthy volunteers."

Asthma • Atopic Dermatitis • Chronic Obstructive Pulmonary Disease • Dermatitis • Dermatology • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • IL13 • IL4

APG808, A Fully Human Monoclonal IgG1 Antibody, Binds to IL-4Rα With High Affinity and Blocks IL-13 and IL-4 Mediated Signalling in Multiple In Vitro Assays (ATS 2024) - "APG808 demonstrated similar potency to dupilumab in multiple in vitro assays. These data provide preclinical evidence of APG808's clinical potential in a variety of diseases where IL-4 and IL-13 induced signaling is the main driver of inflammation."

Preclinical • Asthma • Atopic Dermatitis • Chronic Obstructive Pulmonary Disease • Dermatitis • Dermatology • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • IL13 • IL4 • IL4R

A First-in-human Study of APG808 in Healthy Participants (ANZCTR) - P1 | N=32 | Not yet recruiting | Sponsor: Apogee Therapeutics, Inc.

New P1 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Apogee Therapeutics Announces First Participants Dosed in Phase 1 Trial of APG808, its Novel Half-life Extended IL-4Rα Antibody for the Treatment of Chronic Obstructive Pulmonary Disease (COPD) and Other Inflammatory Diseases (GlobeNewswire) - "Apogee Therapeutics...today announced that it has initiated dosing of healthy volunteers in its first clinical trial for APG808...which is being developed as a treatment for people living with moderate-to-severe COPD, asthma and other I&I diseases....The study will evaluate the safety, tolerability and pharmacokinetics (PK) of APG808 and is expected to enroll approximately 32 healthy adults into four cohorts. Apogee expects interim data from the trial in the second half of 2024, and, pending positive results from the Phase 1 trial and following the submission of an IND or foreign equivalent, plans to initiate a potential Phase 1b trial in asthma with a data readout in the first half of 2025 and a randomized, placebo-controlled Phase 2 clinical trial in patients with moderate-to-severe COPD in 2025."

New P1 trial • New P2 trial • P1 data • Trial status • Asthma • Chronic Obstructive Pulmonary Disease

Apogee Therapeutics Provides Pipeline Progress and Reports Fourth Quarter and Full Year 2023 Financial Results (GlobeNewswire) - "An APG808 Phase 1 healthy volunteer clinical trial is expected to start ahead of schedule following receipt of regulatory clearance in February and will be followed by a potential Phase 1b trial in asthma and a Phase 2 trial in COPD (pending data from the Phase 1 trial). Key milestones in 2024 and 2025 include: Interim Phase 1 PK and safety in healthy volunteers expected in 2H 2024, ahead of prior guidance; Initial proof-of-concept data in asthma expected 1H 2025; Proof-of-concept clinical trial in patients with COPD expected to initiate in 2025, pending positive data from Phase 1 trial and regulatory clearance"

New P1 trial • New P2 trial • P1 data • Asthma • Chronic Obstructive Pulmonary Disease

Apogee Highlights Corporate Progress and Reports Third Quarter 2023 Financial Results (GlobeNewswire) - "Finalized nomination of APG808 development candidate in 4Q 2023: APG808 remains on track to enter the clinic in healthy volunteers in 2024 followed by a Phase 2 trial in COPD (pending data from the Phase 1 trial and following the submission of an IND to support the Phase 2 trial)....Research & Development (R&D) Expenses: R&D expenses for the third quarter of 2023 were $17.1 million, compared to $9.9 million for the third quarter of 2022. R&D expenses increased primarily due to further development of the company’s APG777 and APG808 programs and advancement of its pipeline, as well as increases in personnel costs, including share-based compensation expense, associated with the growth of its R&D team."

Commercial • New P2 trial • Chronic Obstructive Pulmonary Disease

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

Apogee Highlights Corporate Progress and Reports Second Quarter 2023 Financial Results (GlobeNewswire) - "APG808 development candidate selection expected in 4Q 2023: APG808 is an SQ extended half-life mAb program targeting IL-4Rα for the treatment of COPD....Research & Development (R&D) Expenses: R&D expenses for the second quarter of 2023 were $13.9 million, compared to $1.4 million for the second quarter of 2022. R&D expenses increased primarily due to...APG808 program advancements and increases in personnel costs, including share-based compensation expense associated with the growth of R&D team."

Commercial • New trial • Chronic Obstructive Pulmonary Disease • Respiratory Diseases