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
APG777
Fully-optimized, half-life extended IL-13
- 2H 2025: 16-week proof-of-concept data
- 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:
- 2H 2025: 16-week proof-of-concept data
Asthma:
- 2025: Phase 2 trial initiation(1)
APG808
Fully-optimized, half-life extended IL-4Rα
- 2H 2024: Initial Phase 1 PK and safety in healthy volunteers
- 2025: Proof-of-concept trial initiation
- 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 healthy volunteers
- 2025: Proof-of-concept trial initiation
Asthma:
- 1H 2025: Proof-of-concept data
APG990
Fully-optimized, half-life extended OX40L
- 2H 2024: Phase 1 initiation in healthy volunteers
- 2025: Initial PK & safety in healthy volunteers
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.
- 2H 2024: Phase 1 initiation in healthy volunteers
- 2025: Initial PK & safety in healthy volunteers
APG222
Fully-optimized, half-life extended combination IL-13 + OX40L
Our fourth program, APG222, is designed to address multiple immune signaling intervention points through the dual inhibition of IL-13 and OX40L, which we believe could provide benefit for people living with AD and other I&I indications.