Apogee Therapeutics, Inc. (APGE), a clinical-stage biotechnology company, on Monday announced the first patient has been dosed in Part B of the Phase 2 APEX clinical trial of APG777, a novel monoclonal antibody targeting IL-13, for the treatment of moderate-to-severe atopic dermatitis or AD.
The company also completed enrollment of Part A ahead of schedule, surpassing its target with 123 patients enrolled.
The APEX trial is designed to evaluate the safety, efficacy, and dosing regimens of APG777, with Part A showing strong patient enthusiasm and successful enrollment.
In Part A, patients received induction regimen dosing, with the primary endpoint being the mean percentage change in the Eczema Area and Severity Index or EASI score at week 16.
Part B, now underway, will further optimize dosing in approximately 280 patients, comparing high, medium, and low doses of APG777 against a placebo.
Secondary endpoints include EASI-75 and Investigator's Global Assessment or IGA at week 16.
The company anticipates key proof-of-concept data in 2025, including results from Part A at 16 weeks in mid-2025.
APG777 is also being developed for other inflammatory and immunology conditions such as asthma and eosinophilic esophagitis or EoE, with plans to expand its development through additional trials in 2025 and 2026.
Apogee's Chief Medical Officer, Dr. Carl Dambkowski, expressed optimism about APG777's potential, citing its improved dosing schedule and reduced injection burden compared to current therapies.
Currently, APGE is trading at $41.10 down by 0.63%.
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