The company plans to continue developing it, with a goal of moving it in clinical trials in people. It also hopes to treat fibrotic diseases besides scleroderma with the molecule, which is based on iBio’s proprietary endostatin-related peptides portfolio (IBIO-CFB03).
iBio said in a press release that it will conduct preclinical studies to determine the optimal dose and best way to administer the therapy. It will also compare its efficacy and safety with anti-fibrotic drugs approved by the U.S. food and Drug Administration (FDA).
Based on results preclinical work, iBio would submit a New Investigational Drug (IND) application to the FDA that, if approved, would allow for Phase 1 clinical trials testing the fusion protein’s safety as a potential scleroderma treatment. The FDA has already designated the the E4-Fc fusion protein an orphan drug.
Later, iBio expects to evaluate the molecule as a potential treatment for such diseases as pulmonary fibrosis, liver fibrosis, corneal fibrosis, and Chagas disease-induced cardiac fibrosis.
Endostatin is a collagen fragment that blocks cell signals that promote the formation of new blood vessels. In a previous study, Carol Feghali-Bostwick and colleagues at the Medical University of South Carolina found that small proteins derived from endostatin could inhibit and reverse skin and lung fibrosis in human and mice tissue.
The team also demonstrated the E4 peptide’s ability to reverse bleomycin-induced lung fibrosis in a mouse model.
But the peptide had physical properties that made it a less-than-optimal treatment. iBio decided to combine its anti-fibrotic activity with the treatment-related advantages of a fusion protein. Those advantages include safety, greater stability of the therapy’s active component, and an ability to distribute the therapy where it’s needed.
iBio said it chose the E4-Fc fusion protein over other candidates because it had better pharmaceutical and pharmacologic properties.
The preclinical studies will look at the fusion protein’s potential to reduce lung inflammation. Researchers will also try to identify potential biomarkers of its effectiveness.