Details Revealed for Upcoming Phase 2 Study for New AD Drug from Apogee

Apogee Therapeutics’ half-life-extended monoclonal antibody APG777 for atopic dermatitis was the subject of a poster presented by Dr. Emma Guttman-Yassky and others at the 44th Annual Fall Clinical Dermatology Conference.

The poster detailed the design of the phase 2 APEX study.

“IL-13 plays a key role in the pathogenesis of atopic dermatitis, asthma, and other

inflammatory and immunologic conditions,” the authors wrote. “APG777 is a humanized, IgG1 monoclonal antibody that potently binds IL-13 and prevents IL-13Rα1/IL-4Rα heterodimer formation.”

Interim data from the single-ascending dose portion of a phase 1 study in healthy

human volunteers demonstrated that APG777 has a half-life of approximately 75 days and provides strong inhibition of downstream biomarkers pSTAT6 and TARC, and that it is well tolerated at doses up to 1200 mg. The favorable safety profile and optimized pharmacokinetics supported the initiation of a phase 2 study in adults with moderate-to-severe atopic dermatitis, evaluating every 3- to 6-month maintenance dosing.

The two-part, randomized, double--blinded, placebo-controlled phase 2 study will consist of Part A, a 16-week proof-of-concept period, followed by a 36-week maintenance period, and then a 52-week follow-up period; and Part B, a global 16-week dose-optimization period, followed by a 36-week maintenance period, and then a 52-week follow-up period.

The APEX study (NCT06395948) is currently enrolling.