Washington Research Foundation (WRF) has awarded a $700,000 phase three technology commercialization grant to Stephanie Berger, Ph.D., to support the development of an oral biologic for inflammatory bowel disease (IBD). Berger, a translational investigator at the Institute for Protein Design, received two previous grants totaling $300,500 from WRF for this work.
IBD affects roughly three million people in the United States, and rates of diagnosis are increasing. IBD is characterized by chronic inflammation of the gastrointestinal (GI) tract that results in abdominal pain and bloody diarrhea, leading to poor quality of life, malnutrition and dehydration. Severe cases can require parenteral nutrition or bowel resection surgery. Untreated IBD leaves patients at high risk of colorectal cancer.
The standard of care for patients with IBD is oral steroids and broadly immunomodulating small molecules for mild to moderate disease, and injectable biologics for moderate to severe disease. These therapies act by systemic suppression of the immune system, which increases the patient’s risk of serious
infections.
With the assistance of earlier grants from WRF, Berger has been developing an oral biologic for IBD that specifically targets interleukin-23 receptor (IL-23R) in the gut. IL-23R is an established target in autoimmune diseases including IBD; blocking it can relieve or eliminate IBD symptoms. Local delivery to the site of inflammation by oral administration can improve safety and convenience compared to systemic injectables. Oral administration of biologics is challenging because most molecules will degrade in the harsh conditions of the gut. Berger and her colleagues at the IPD have developed de novo proteins resistant to gastrointestinal conditions to address this limitation and enable the therapy to retain its efficacy as it reaches its target.
