iBio secured Clinical Trial Notification acknowledgement from Australia’s Therapeutic Goods Administration and ethics approval from a Human Research Ethics Committee, enabling initiation of a randomized, double-blind, placebo-controlled, single ascending dose Phase 1 trial of IBIO-600 in overweight and obese adults. The study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics, with first participant dosing slated for Q2 2026.

Preclinical trials in non-human primates demonstrated sustained pharmacologic activity with an extended half-life of 40–52 days, dose-dependent lean mass gains up to 5.1%, reductions in fat mass and durable effects over time. The long-acting monoclonal antibody targets myostatin and GDF11 and is engineered for infrequent dosing, potentially two to four administrations per year.

Advancing IBIO-600 into human trials marks iBio’s shift from discovery to clinical-stage, highlighting the speed and capabilities of its AI-integrated drug discovery platform. The therapy aims to preserve lean mass, improve body composition and could be co-administered with GLP-1 treatments to counteract muscle loss associated with weight reduction.