iBio, Inc., a specialist in developing plant-based therapeutics, hosted shareholders and attendees at its Annual Meeting on Thursday, December 11, and presented a comprehensive update on the company’s ongoing activities and R&D progress for one of their lead pipeline products, IBIO-CFB03, formulated to treat fibrotic diseases such as idiopathic pulmonary fibrosis (IPF), systemic sclerosis (SSc).
IBIO-CFB03 was developed by Dr. Feghali-Bostwick at the Medical University of South Carolina (MUSC), who is now in close collaboration with iBio in preparing for and conducting clinical trials for the experimental drug. Dr. Feghali-Bostwick had published findings on the ability of specific endostatin-derived peptides to stop and repair fibrotic damage in mice models of fibrosis, as well as in human skin. The company has successfully obtained exclusive, worldwide license for IBIO-CFB03’s active and pending patents fundamental to these developments, and launched a dynamic program to synthesize the active pharmaceutical ingredient and its derivatives out of plants through its proprietary iBioLaunch™ technology. At present, iBio has several primary formulations of the IBIO-CFB03 for evaluation to proceed to clinical testing. The company is also working on filing for an investigational new drug application (IND) with the US Food and Drug Administration, which is expected to be completed by mid-2015.
Preclinical findings on the safety and efficacy of IBIO-CFB03 have been encouraging, making it a top priority in advancement to clinical trials. The product is also indicated for the treatment of two serious diseases that have largely unmet medical needs, which makes its upcoming Phase I clinical trial critical. The trial will test IBIO-CFB03’s safety in healthy individuals, as well as efficacy in treating participants. iBio is confident its aggressive efforts in developing IBIO-CFB03 will not only accelerate its progress towards approval for fibrotic diseases like IPF and SSc, but will also facilitate testing for at least two other clinical indications.
A world-class clinical advisory board formed earlier this year will be working closely with iBio on its development program for IBIO-CFB03. Board members include Dr. Thomas A. Medsger, Jr., a world-renowned epidemiologist on scleroderma and systemic sclerosis, Dr. Richard M. Silver, a world leader in clinical care and investigation of systemic sclerosis, Dr. Timothy Blackwell, an international expert in IPF and other lung diseases, and Dr. J. Terrill Huggins, a prominent clinical researcher in the field of IPF.