iBio, Inc. 8K

iBio, Inc. received Australian regulatory and ethics clearance to begin a Phase 1 first-in-human clinical trial of its anti-myostatin antibody IBIO-600 in overweight and obese adults, with first dosing expected in 2Q 2026.

On April 8, 2026, iBio, Inc. announced that it received Clinical Trial Notification acknowledgment from Australia’s Therapeutic Goods Administration and ethics approval from a Human Research Ethics Committee to initiate a first-in-human Phase 1 clinical trial of IBIO-600, a potentially long-acting anti-myostatin monoclonal antibody targeting myostatin and GDF11 in overweight and obese adults, with first dosing expected in the second quarter of 2026; the randomized, double-blind, placebo-controlled, single ascending dose study will evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics and is supported by prior non-human primate data showing sustained pharmacologic activity, extended half-life, and dose-dependent increases in lean mass, positioning iBio as a clinical-stage company pursuing combination use with GLP-1 therapies.

Filing Facts

CIK

1420720

Ticker

-

Form

8K

Source Type

sec

Accession

0001104659-26-040703

Alert Tier

6