Pending final data from our Phase 1 trial of APG777 in healthy volunteers, we may initiate a Phase 2 trial in asthma and expect to further evaluate opportunities to develop APG777 for other I&I indications, including alopecia areata, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, eosinophilic esophagitis and prurigo nodularis.
(1)Our philosophy is simple.
Our goal is to discover and develop new differentiated therapies for a range of I&I indications. We aim to accomplish this goal by focusing on known biologic drivers of disease and utilizing advanced antibody engineering to develop product candidates with optimized properties that have the potential to overcome limitations of existing therapies. We believe our approach will enable us to develop a portfolio of therapies that are differentiated compared to the currently available standards of care and address unmet medical needs for I&I indications.
Pipeline
Discovery
PRECLINICAL
PHASE 1
PHASE 2
PHASE 3
NEXT ANTICIPATED MILESTONES
Half-life extended IL-13
APG777- 1H 2024: Phase 2 trial initiation(1)
- 2H 2025: 16-week proof-of-concept data in AD patients
- 2025: Phase 2 trial initiation(1)
Our most advanced program, APG777, has been engineered to bind to and inhibit IL-13, preventing the onset of an exaggerated immune response. IL-13 is a protein that plays an essential role in the body’s immune response. IL-13 is often overproduced in atopic dermatitis, leading to a weakened skin barrier that allows bacteria and pathogens to enter the skin more easily and exacerbated inflammatory responses which can cause itching, red skin, and further damage. IL-13 is a well-established target for the treatment of AD. APG777 has also been designed to bind to FcRn with high affinity, extending half-life considerably and potentially requiring less frequent dosing.
Atopic Dermatitis:
- 1H 2024: Phase 2 trial initiation(1)
- 2H 2025: 16-week proof-of-concept data in AD patients
Asthma:
- 2025: Phase 2 trial initiation(1)
Half-life extended IL-4Rα
APG808- 2H 2024: Initial Phase 1 PK and safety in HV
- 2025: Proof-of-concept trial initiation in COPD
- 1H 2025: Proof-of-concept data
Our second most advanced program, APG808, has been engineered to bind to and block IL-4Ra[EC1] to modulate dysregulated immune activity and to FcRn with high affinity to extend antibody half-life and potentially requiring less frequent dosing. IL-4Ra is a protein receptor that interacts with IL-13 and IL-4 as part of the body’s natural inflammatory response. In COPD, this inflammatory signaling occurs more frequently and can trigger an exaggerated immune response. IL-4Ra is a well-established target for the treatment of COPD.
Chronic Obstructive Pulmonary Disease:
- 2H 2024: Initial Phase 1 PK and safety in HV
- 2025: Proof-of-concept trial initiation in COPD
Asthma:
- 1H 2025: Proof-of-concept data
Half-life extended OX40L
APG990- 2024: Candidate nomination
- 2025: Phase 1 initiation in HV
Our third program, APG990, has been engineered to bind to OX40L, blocking interactions with OX40 and rebalancing cellular immune responses in AD. OX40L and its receptor, OX40, are important regulators of cellular immune responses. Imbalances in the OX40L and OX40 system and, thus, imbalances between pro-inflammatory and anti-inflammatory T cells, have been implicated in the pathogenesis of AD. Inhibiting the OX40-OX40L pathway could represent another therapeutic option for people living with AD, especially for those who do not benefit from currently available treatments. APG990 has also been designed to bind to FcRn with high affinity, extending biologic circulation times potentially requiring less frequent dosing.
- 2024: Candidate nomination
- 2025: Phase 1 initiation in HV
Half-life extended combination IL-13 and OX40L
APG222Our fourth program, APG222, is designed to address multiple immune signaling intervention points through the dual inhibition of OX40L and IL-13, which we believe could provide benefit for people living with AD and other I&I indications.