iBio Secures Phase 1 IBIO-600 Clearance, IBIO-610 Cuts Visceral Fat by 6.7%
iBio secured TGA approval to begin a Phase 1 trial of IBIO-600 in obese adults and expanded its pipeline with a bispecific antibody for PH-HFpEF. Preclinical IBIO-610 NHP data showed 6.7% visceral and 5.2% total fat reduction; cash of $74.8 million plus $17 million from warrants extends runway into Q4 FY2028.
1. Phase 1 IBIO-600 Trial Clearance
iBio received Clinical Trial Notification acknowledgment and ethics approval in Australia to initiate a randomized, double-blind, placebo-controlled, single ascending dose Phase 1 study of IBIO-600 in overweight and obese adults. First participant dosing is expected in calendar Q2 2026 to assess safety, tolerability, pharmacokinetics and pharmacodynamics.
2. Expansion into PH-HFpEF Pipeline
The company has added a selective bispecific antibody targeting Activin A, GDF8 (myostatin) and GDF11 to its pipeline, aiming to address pulmonary hypertension associated with heart failure with preserved ejection fraction by reducing cardiac fibrosis and reversing pulmonary vascular remodeling without broader TGFβ blockade risks.
3. Preclinical IBIO-610 Fat Reduction Data
In a small obese non-human primate study, two doses of IBIO-610 delivered once every eight weeks led to a 6.7% reduction in visceral fat and a 5.2% reduction in total fat mass, with slight lean-mass gain observed, highlighting potential body-composition benefits.
4. Financial Position and Runway
For Q3 FY2026, R&D expenses rose to $3.3 million and G&A to $5.1 million, partly due to a $2.5 million impairment charge. As of March 31, 2026, the company held $74.8 million in cash and equivalents and raised $17 million from warrant exercises, extending its cash runway into Q4 FY2028.