September 24, 2015
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NIH issues grant funding for development of oral IL-23 receptor antagonists for IBD

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The National Institute of Diabetes and Digestive and Kidney Diseases of the National Institute of Health has issued a phase 1 Small Business Innovation Research Grant to Protagonist Therapeutics for the development of orally stable peptide antagonists of the interleukin-23 receptor as possible treatments for inflammatory bowel disease, the drugmaker announced.

“We are very pleased to receive this grant, which provides further validation of the strong potential offered by our technology platform for the creation of novel, orally stable peptide drugs,” David Y. Liu, PhD, chief scientific officer of Protagonist, said in a press release. “Through this award, the reviewers also recognize the considerable benefit which could be provided for the treatment of inflammatory bowel disease through a first-in-class therapeutic targeting the IL-23/Th17 pathway. The [Small Business Innovation Research] program at NIH plays a vital role in helping companies develop new technology and products that serve important U.S. health care needs.”

The efficacy of orally stable, GI-restricted drugs for colitis has been demonstrated in rodent models, and the Small Business Innovation Research grant will support the development of a potential human drug that can be administered orally at high levels, target affected intestinal tissue and limit systemic circulation, according to the press release. The role of the IL-23/Th17 pathway in chronic intestinal inflammation has been established by prior research and the role of upregulation of IL-23 and its receptor has been linked to the development of a number of chronic inflammatory disorders, including IBD.

“Since IBD represents local inflammation of the intestinal tissue, an ideal therapeutic would act within the confines of the intestine for enhanced efficacy while minimizing systemic bioavailability for enhanced safety,” Dinesh Patel, PhD, president and CEO of Protagonist, said in the press release. “A drug with these characteristics would have the potential to transform the treatment of IBD by providing safe, effective and durable therapy for chronic treatment. This award will help us develop a new oral asset for IBD stemming from Protagonist’s proprietary technology platform that acts specifically to inhibit the IL-23/Th17 pathway. In the long run, it is critical to develop safe and effective drugs working through different mechanisms to serve unmet medical needs for chronic illnesses like IBD.”

Disclosures: Liu and Patel report they are employees of Protagonist Therapeutics.