Apogee announces first participants dosed in Phase 1 trial of APG990

Apogee Therapeutics announced that it has initiated dosing of healthy volunteers in its first clinical trial for APG990, a novel, subcutaneous half-life extended monoclonal antibody targeting OX40L, which is being developed initially as a treatment for people living with AD. The APG990 Phase 1 clinical trial is designed as a double-blind, placebo-controlled, first-in-human, single-ascending dose trial in healthy volunteers. The study will evaluate the safety, tolerability and pharmacokinetics of APG990 and is expected to enroll approximately 40 healthy adults into 5 cohorts. Apogee expects interim data from the trial in 2025. Pending positive results from the Phase 1 clinical trial and following submission of an Investigational New Drug application or foreign equivalent, the company plans to initiate a Phase 1 clinical trial of APG777 and APG990 as a potential first-in-class approach to test the combination of deep and sustained inhibition of Type 2 inflammation via APG777’s targeted inhibition of IL-13 with broader inhibition of Type 1-3 inflammation through APG990’s inhibition of OX40L. The company plans to initiate the first clinical trial of the APG777 and APG990 combination in 2025.