IBIO News & Events

iBio announced IBIO-600 has received clinical trial notification acknowledgement from Australia's Therapeutic Goods Administration and ethics approval from a Human Research Ethics Committee, enabling the initiation of a first-in-human clinical trial of IBIO-600 in Australia. The Phase 1 study is a randomized, double-blind, placebo-controlled, single ascending dose trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IBIO-600 in overweight and obese adult participants. iBio expects to dose the first participant in the second quarter of 2026.

iBio announced new preclinical data from its obese non-human primate study evaluating IBIO-610, potentially a first-in-class Activin E antibody candidate. The preclinical body composition data demonstrates IBIO-610 reduced fat mass in obese NHPs compared to vehicle-treated obese NHPs, in a small, not statistically powered study. Following two once-every-eight-week dosing, IBIO-610 reduced visceral fat by 6.7% and total fat mass by 5.2%, with only a slight up-tick in lean mass following treatment. This fat-selective profile in our NHP study is consistent with the effects we previously observed in rodents and with body composition outcomes reported by other companies in human clinical trials targeting the Activin E pathway. These data support continued evaluation of IBIO-610's potential as a differentiated therapy in obesity, cardiometabolic and cardiopulmonary diseases.