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iBio Becomes a Clinical-Stage Company with First Participant Dosed in Phase 1 Clinical Trial of IBIO-600 in Adults with Obesity

IBIO
  • iBio, Inc. announced the dosing of the first participant in the Phase 1 clinical trial of IBIO-600, marking the company's transition to a clinical-stage biotechnology entity.
  • IBIO-600 is a long-acting monoclonal antibody designed to target myostatin & GDF11 to preserve muscle mass & improve body composition during weight reduction.
  • The investigational therapy aims to address lean mass loss associated with weight reduction, including potential combination use with GLP-1-based therapies.
  • Non-human primate data showed a 40-to-52-day half-life after a single administration & demonstrated lean mass gains up to 5.1% with fat mass reductions.
  • The Phase 1 trial is a randomized, double-blind, placebo-controlled, single ascending dose study enrolling approximately 32 adults with overweight & obesity.
  • Participants will be monitored for approximately nine months following administration, with study completion expected in the second half of 2027.
  • The trial will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, & exploratory effects on body composition.
  • CEO Martin Brenner stated the AI-driven platform advanced the program to human studies approximately two years after initiation.
  • iBio anticipates advancing its Activin E program, IBIO-610, into the clinic in the first half of 2027.
  • iBio is a clinical-stage biotechnology developing long-acting antibody therapeutics for obesity, cardiometabolic, cardiopulmonary diseases, & cancer using AI-driven discovery.