iBio has received approval to initiate a first-in-human clinical trial for its long-acting monoclonal antibody IBIO-600 in Australia. 

The Phase I study is a randomised, 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. 

“This is a defining milestone for iBio as we transition to a clinical-stage company,” said Martin Brenner, Chief Executive Officer and Chief Scientific Officer of iBio. “While GLP-1 therapies have transformed the treatment landscape, significant gaps remain, particularly around the loss of muscle mass. We believe IBIO-600 has the potential to address this unmet need. Advancing IBIO-600 into the clinic only two years after programme initiation also reflects the capabilities of our AI-integrated discovery platform and our team’s execution.” 

IBIO-600 is a long-acting monoclonal antibody targeting myostatin and GDF11, negative regulators of skeletal muscle growth, and is designed to preserve lean mass and improve body composition in obesity.  

The therapy has the potential to be used alongside GLP-1 therapies to address muscle loss associated with weight reduction. IBIO-600 has been engineered for infrequent dosing, with the potential for administration two to four times per year. 

Previously announced preclinical studies in non-human primates demonstrated sustained pharmacologic activity and an extended half-life of 40-52 days following a single administration, as well as dose-dependent increases in lean mass of up to 5.1%. These findings, observed alongside reductions in fat mass and durable effects over time, support the advancement of IBIO-600 into clinical development.