Apogee Therapeutics, Inc. (NASDAQ: APGE) has announced the dosing of the first patient in the part B portion of the phase 2 APEX clinical trial of APG777 in patients with moderate-to-severe atopic dermatitis (AD). This follows the successful completion of enrollment in the part A portion of the trial, which exceeded the enrollment target with 123 patients enrolled.
The company's Chief Medical Officer, Carl Dambkowski, M.D., highlighted that enrollment for the phase 2 part A trial of APG777 surpassed the approximately 110 patient target ahead of schedule, driven by strong patient and investigator enthusiasm. This underscores the potential of APG777 to address the need for safe, effective treatment options that reduce injection burden and provide better disease control for patients with AD and other inflammatory and immunology (I&I) conditions.
The trial is evaluating APG777, a novel, subcutaneous extended half-life monoclonal antibody targeting IL-13 – a critical cytokine in inflammation and a primary driver of AD, in patients with moderate-to-severe AD. Part A of the trial exceeded expected enrollment with 123 patients randomized 2:1 to APG777 versus placebo. Patients assigned to APG777 received induction regimen dosing of 720mg at weeks 0 and 2, followed by 360mg at weeks 4 and 12.
APG777 is currently in clinical development as a monotherapy for AD with several proof-of-concept anticipated readouts in 2025 and 2026, including part A 16-week induction data in mid-2025 and maintenance data in the first half of 2026 as well as part B 16-week data in the second half of 2026. Furthermore, Apogee plans to advance the development of APG777 in expansion indications by initiating a phase 1b trial in asthma in the first half of 2025, followed by a phase 2b trial in asthma in the second half of 2025, and launching a phase 2 trial in eosinophilic esophagitis (EOE) in 2026.
APG777 is a novel, subcutaneous half-life extended monoclonal antibody targeting IL-13 for the potential treatment of AD. In head-to-head preclinical studies, APG777 showed equivalent or better potency to lebrikizumab in the inhibition of IL-13 signaling. APG777 phase 1 trial data out to 12 months demonstrated a half-life of 77 days, a consistent safety, and favorable pharmacodynamic profile showing near complete inhibition of pSTAT6 for up to 12 months after a single administration and sustained TARC inhibition.
Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, including for the treatment of AD, asthma, chronic obstructive pulmonary disease (COPD), EOE, and other I&I indications. The company’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Following these announcements, the company's shares moved -1.1%, and are now trading at a price of $40.91. If you want to know more, read the company's complete 8-K report here.
