iBio, Inc. has released the latest information on the development of IBIO-CFB03, a therapy designed to address significant unmet medical needs for the treatment of fibrotic diseases, including systemic sclerosis (SSc) and idiopathic pulmonary fibrosis (IPF). The company, which creates plant-derived pharmaceutical products, presented the news to their shareholders and other attendees at the company’s Annual Meeting.
iBio has been working throughout this year in collaboration with the inventor of IBIO-CFB03, Feghali-Bostwick at the Medical University of South Carolina (MUSC), to conduct clinical trials to assess the drug. Bostwick was able to demonstrate that specific endostatin-derived peptides’ inhibition properties reversed fibrosis during preclinical studies in mouse models of fibrosis and in human skin.
Preclinical studies conducted by iBio to date revealed the lack of significant toxicity caused by the drug, and corroborated the company’s decision to make IBIO-CFB03 a high priority. Therefore, iBio is now planning to conduct a phase 1 clinical trial designed to assess the safety of the therapeutic in healthy participants, as well as look for evidence of its preliminary efficacy in patient volunteers. iBio and its clinical advisory board believe that the strategy may be able to accelerate overall clinical development of IBIO-CFB03, as well as lead to the start of two new parallel clinical indications for the medication.
The clinical program will be supervised by a clinical advisory board created by iBio this year, which includes epidemiology specialist Thomas A. Medsger, Jr., who has worked on clinical and laboratory research for systemic sclerosis and localized forms of scleroderma, Raynaud disease and polymyositis/dermatomyositis. In addition, Richard M. Silver, M.D., a systemic sclerosis investigator; IPF specialist Timothy Blackwell, M.D.; and IPF clinical researcher J. Terrill Huggins were also selected for the advisory board.
In addition, the company has been granted an exclusive, worldwide license for the patents and pending patents for Dr. Feghali-Bostwick’s discoveries, and has begun a series of projects to manufacture the active pharmaceutical ingredient, as well as other potentially valuable derivatives. The company aims to produce them in plants through the use of their iBioLaunch technology. The company is currently working to file an investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA), a process that is expected to be completed by the middle of next year.