The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), an institute that is part of the National Institute of Health (NIH), recently granted a Phase 1 Small Business Innovation Research Grant to Protagonist Therapeutics. The grant will foster the development of a new drug for the treatment of Inflammatory Bowel Disease (IBD). The drug is an orally administered peptide that blocks interleukin-23 (IL-23) receptor activity, since it was shown that IL-23 and IL-23 receptor levels are increased in several chronic inflammatory disorders and orchestrate intestinal inflammation via multiple pathways.

Efficacy was demonstrated in rodent models and now the Research Grant will help Protagonist Therapeutics to develop a human drug that will effectively target the intestinal tissue (and hence decrease its systemic effects), and can therefore be administered in high doses.

David Y. Liu, PhD, chief scientific officer of Protagonist, commented in a news release, “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. 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.”

Dinesh Patel, PhD, president and CEO of Protagonist added, “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. 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.”