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news.iBio, a provider of plant-based biotechnology for developing and manufacturing biopharmaceutical products, has added a proprietary biotherapeutic product for the treatment of idiopathic pulmonary fibrosis (IPF) and systemic sclerosis to its product pipeline.
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iBio obtained an exclusive license to patents and related intellectual property for this novel therapy, and then entered a collaboration agreement with the Medical University of South Carolina (MUSC), represented by Dr Carol Feghali-Bostwick, the inventor and now the Kitty Trask Holt and SmartState SC Centers of Economic Excellence Endowed Professor at MUSC, that will enable iBio to advance the development of a potentially breakthrough biotherapeutic product against these otherwise unstoppable diseases.
Effective treatment of IPF, systemic sclerosis and localized scleroderma, represents an unmet medical need. Although some limited results have been claimed for existing therapies, there are currently no effective therapies for stopping or reversing fibrosis.
Data published in 2012 by Feghali-Bostwick demonstrates that certain endostatin-derived peptides are useful for both inhibition and reversal of fibrosis in preclinical mouse models of fibrosis as well as in human skin (Science Translational Medicine, 2012).
iBio has initially expressed the active pharmaceutical ingredient for this product using its patented iBioLaunch technology, and plans to make clinical development of this product a key priority in the proprietary application of iBioLaunch.
The prevalence of systemic sclerosis is 150 to 300 cases per million persons in the U.S. and Europe (Current Opinion in Rheumatology, 2012). The prevalence of IPF, depending on the diagnostic criteria used, ranges from 140 to 279 cases per million persons in the US and up to 234 cases per million in Europe (European Respiratory Review, 2012).
iBio chairman and CEO Robert B Kay noted by bringing together iBio technology with the discovery work led by Dr Feghali-Bostwick, the company’s goal is to begin human clinical trials in 2014.
"If the results are consistent with the pre-clinical results, we will request a Breakthrough Therapy Designation from the FDA for our product in order to make it available for use at the earliest possible time.
"iBio technology has been successful in addressing complex protein production problems for vaccine development that were difficult or impossible to solve with other technologies, and those products are now advancing into Phase 1 human clinical trials. We expect similar success with the expression of this new product," Kay added.