iBio, Inc. (NASDAQ:IBIO) ("iBio" or the "Company"), a clinical-stage AI-driven innovator developing therapies for cardiometabolic and cardiopulmonary diseases and obesity, today announced the dosing of the first participant in its Phase 1 clinical trial of IBIO-600, the Company's most advanced obesity and cardiometabolic asset and its first program to enter human clinical development. This milestone marks iBio's transition to a clinical-stage biotechnology company.

IBIO-600 is a long-acting monoclonal antibody engineered for infrequent dosing and designed to target myostatin and GDF11, negative regulators of skeletal muscle growth. The investigational therapy is being developed for its potential to support muscle preservation and improve body composition during weight reduction, including in combination with GLP-1-based therapies. In non-human primates, a single administration of IBIO-600 produced a prolonged 40-to-52-day half-life, supporting the potential for extended half-life in humans. IBIO-600 also demonstrated durable body composition effects, including lean mass gains of up to 5.1% with accompanying reductions in fat mass.

The Phase 1 clinical trial is a randomized, double-blind, placebo-controlled, single ascending dose trial currently enrolling adults with overweight and obesity. The study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IBIO-600, as well as exploratory effects on body composition. Approximately 32 individuals are expected to enroll and will be monitored for approximately nine months following administration, with study completion expected in second half of 2027. Data from the study will help inform potential future development of IBIO-600.