Shape

Apogee Therapeutics is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis (AD), chronic obstructive pulmonary disease (COPD) and other inflammatory and immune (I&I) diseases with high unmet need.

Close-up of photo of a woman’s chest, shoulder, and arm with atopic dermatis rash on arm

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.

Improving treatment options for people with atopic dermatitis and chronic obstructive pulmonary disease

Our initial focus is atopic dermatitis (AD) and chronic obstructive pulmonary disease (COPD).

AD is a chronic inflammatory skin disorder that is estimated to affect 40 million adults and 18 million children in the United States, France, Germany, Italy, Japan, Spain and the United Kingdom. Despite recent advancements in treatment, a significant number of people living with AD continue to suffer from active disease. Today’s treatments are associated with many challenges, including a high frequency of injections that may lead to poor compliance.

COPD is a progressive respiratory disease that is estimated to affect approximately 10% of the global population 40 years of age and older. Despite recent advancements in COPD treatment, a significant number of people continue to suffer and die from the disease.

Our antibody programs are designed to overcome limitations of existing therapies by leveraging well-established mechanisms and incorporating advanced antibody engineering to optimize half-life and other properties. Based on our preclinical studies, we believe APG777 can be dosed either every two or every three months in maintenance, which, if our clinical trials are successful, would represent a significant improvement compared to currently available antibodies that are dosed every two to four weeks. We believe each of our programs has potential for broad application across multiple I&I indications.

Pipeline

Discovery
PRECLINICAL
PHASE 1
PHASE 2
PHASE 3
NEXT ANTICIPATED MILESTONES

Half-life extended IL-13

APG777

ATOPIC DERMATITIS

ATOPIC DERMATITIS

PHASE 1

  • Phase 1 trial initiated
  • Initial SQ PK and safety data in healthy participants
  • Phase 2 trial initiation(1)
  • Proof-of-concept data

ASTHMA

ASTHMA

PRECLINICAL

  • 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. We expect this program to enter clinical trials in 2023.

Next Anticipated Milestones

Atopic Dermatitis:

  • Phase 1 trial initiated
  • Initial SQ PK and safety data in healthy participants
  • Phase 2 trial initiation(1)
  • Proof-of-concept data

Asthma:

  • Phase 2 trial initiation(1)

Half-life extended IL-4Rα

APG808

CHRONIC OBSTRUCTIVE PULMONARY DISEASE

CHRONIC OBSTRUCTIVE PULMONARY DISEASE

PRECLINICAL

  • Nominated Candidate
  • Phase 1 trial initiation

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.

Next Anticipated Milestones
  • Nominated Candidate
  • Phase 1 trial initiation

Half-life extended OX40L

APG990

ATOPIC DERMATITIS

ATOPIC DERMATITIS

PRECLINICAL

  • Nominate Candidate

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.

Next Anticipated Milestones
  • Nominate Candidate

Half-life extended combination IL-13 and OX40L

APG222

ATOPIC DERMATITIS

ATOPIC DERMATITIS

PRECLINICAL

Our 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.

Pending 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)