Apogee Therapeutics, Inc. announced that it has initiated dosing in the Phase 2 trial of APG777 in patients with moderate-to-severe atopic dermatitis. APG777 is a novel, subcutaneously-administered half-life extended monoclonal antibody targeting IL-13 ? a critical cytokine in inflammation and a primary driver of AD.

The APG777 Phase 2 clinical trial is a randomized, placebo-controlled, 16-week trial in patients with moderate-to-severe AD. The trial was designed to combine the typical Phase 2a and 2b portions of a clinical trial into a single protocol. Part A is expected to enroll approximately 110 patients randomized 2:1 to APG777 vs.

placebo; patients receiving APG777 will receive induction regimen dosing of 720mg at weeks 0 and 2, followed by 360mg at weeks 4 and 12. Patients benefiting from treatment will continue to APG777 maintenance, which will evaluate 3- to 6-month dosing. Part B is a placebo-controlled dose optimization with approximately 360 patients randomized 1:1:1:1 to high, medium, or low dose APG777 vs.

placebo. The primary endpoint of each part of the study is mean percentage changes in EASI score from baseline to Week 16. In head-to-head preclinical studies, APG777 demonstrated equivalent or better potency to lebrikizumab in the inhibition of IL-13 signaling.

Based on its potentially best-in-class pharmacokinetic (PK) profile, APG777 has the potential for improved clinical responses due to greater exposures of drug in induction while dosing as infrequently as once every three or six months. AD is a chronic inflammatory skin disorder which can lead to sleep disturbance, psychological distress, elevated infection risk and chronic pain, all of which significantly impact quality of life. Today?s treatments are associated with many challenges, including frequent injection regimens that can lead to poor patient compliance.

APG777 is a novel, subcutaneous half-life extended monoclonal antibody targeting IL-13 for the potential treatment of atopic dermatitis (AD). In head-to-head preclinical studies, APG777 showed equivalent or better potency to lebrikizumab in the inhibition of IL-13 signaling. AD is a chronic inflammatory skin disorder that affects approximately 40 million adults and 18 million children in the United States, France, Germany, Italy, Japan, Spain and the United Kingdom, 40% of which have moderate-to-severe disease.

Based on initial clinical data, the company plans to initiate a Phase 2 trial in asthma and plans 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.