Biotechnology company iBio Inc. recently provided updates at its Annual Meeting for shareholders and attendees on the development progress of IBIO-CFB03 and its potential to address unmet medical needs for the treatment of idiopathic pulmonary fibrosis (IPF) and other fibrotic diseases.
The creator of IBIO-CFB03, Dr. Feghali-Bostwick from the Medical University of South Carolina (MUSC), and iBio collaborated in developing the drug, which will be tested in future clinical trials. In the past, Dr. Feghali-Bostwick published research data revealing that some very specific endostatin-derived peptides such as IBIO-CFB03 reverse and inhibit fibrosis in mice models and in human skin.
iBio currently holds the worldwide license for all patents regarding these scientific discoveries, including pending patents. iBio is advancing the discoveries through its iBioLaunch™ technology, wherein active pharmaceutical ingredients and valuable derivatives are developed in plants. Now, a new drug application (IND) is being filed with the FDA, which iBio expects will be completed by the middle of next year.
The preclinical results for IBIO-CFB03 showed that efficacy and lack of significant toxicity justify high priority advancement of the product into clinical trials. Furthermore, given the major unmet medical needs related to fibrotic conditions that this treatment can potentially address, the company is preparing to invest in Phase 1 clinical trials. These trials will evaluate safety in healthy volunteers and look for evidence of its respective efficacy in participants with fibrosis. iBio believes that this strategy will accelerate IBIO-CFB03’s development and eventually lead to two more clinical indications.
The development program will be guided by an advisory board established by iBio in 2014; according to a company press release: “The board includes Dr. Thomas A. Medsger, Jr., an internationally recognized expert on the epidemiology, clinical and laboratory features and natural history of systemic sclerosis and localized forms of scleroderma, Raynaud’s disease and polymyositis/dermatomyositis. Richard M. Silver, M.D., one of the world’s leaders in clinical care and investigation of systemic sclerosis, Timothy Blackwell, M.D., an internationally recognized expert in IPF and other lung diseases, and Dr. J. Terrill Huggins, a leading clinical investigator in the field of IPF.”