Apogee Doses First Patient in Phase 2 APEX Trial for Atopic Dermatitis

Apogee Therapeutics, Inc., a biotechnology firm in the clinical stage, announced that the initial patient has received treatment in Part B of the phase 2 APEX clinical trial of APG777 for individuals with moderate-to-severe atopic dermatitis (AD), and that enrollment has been finalized in Part A of the trial.

“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, underscoring 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 I&I conditions,” said Carl Dambkowski, M.D., chief medical officer of Apogee. “Positive results from our phase 1 healthy volunteer trial enabled us to design this phase 2 trial whereby APG777 is modeled to exceed lebrikizumab exposures by ~30-40% with potential for improved clinical responses, as well as approximately half the number of injections during induction and ~70-90% fewer injections in maintenance compared to currently available therapies. Our uniquely designed phase 2 trial allowed us to seamlessly transition from completing enrollment in Part A to enrolling Part B within one week, streamlining the clinical development process and potentially enabling us to bring APG777 to patients sooner.”

APEX is a phase 2 randomized, placebo-controlled study assessing APG777, a new subcutaneous (SQ) extended half-life monoclonal antibody (mAb) that targets IL-13, an essential cytokine in inflammation and a key factor in AD, in individuals with moderate-to-severe AD. The study was aimed at merging the usual phase 2a and 2b segments of a clinical trial into one protocol.