Protagonist Therapeutics Receives $1.34 Million SBIR Funding for Development of Biomarkers of IL-23 Receptor Antagonist Activity

NEWARK, Calif., May 24, 2017 /PRNewswire/ -- Protagonist Therapeutics, Inc. (Nasdaq: PTGX) today announced the receipt of a Phase 2 Small Business Innovation Research (SBIR) Grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH).  This award, Number 2R44DK104445-02, provides up to $1.34 million over two years to support research aimed at developing biomarkers that define IL-23 receptor (IL-23R) target engagement by oral peptide antagonists and the effects of that engagement on downstream signaling. Such biomarkers can be used for demonstrating early pharmacodynamics clinical proof-of-concept and estimating effective dose range for the treatment of inflammatory bowel diseases (IBD) with anti-IL-23R agents, including Protagonist's oral peptide drug candidate, PTG-200. The company expects to initiate human clinical testing of PTG-200 in the second half of 2017.

Protagonist's research has shown that oral treatment with PTG-200 significantly improves disease outcomes in an animal model of colitis through specific inhibition of the IL-23R signaling pathway. Moreover, treatment-related responses from biomarkers profiled in this research, including biomarkers identified and tracked in blood, feces, and/or colon biopsies, provide a potentially valuable way of assessing mechanism-specific and disease-related parameters, as well as demonstrating clinical effect in human trials.

"We are very pleased to receive this grant, which recognizes the considerable benefit that could be provided by biomarkers of IL-23R signaling activity in IBD," said Dinesh Patel, Ph.D., Protagonist Therapeutics' President and Chief Executive Officer. "The SBIR program at NIH plays a vital role in helping companies develop new technology and products that serve important U.S. health care needs, and we sincerely thank them for their support."

"This award will help us further develop accessible and measurable biomarkers that are useful for understanding the ability of our oral peptide agents to target and modulate the activity of IL-23 receptors in the gastrointestinal tract, for demonstrating early pharmacodynamic activity in human trials, and for choosing the appropriate dose ranges of such agents for clinical development in IBD," said David Y. Liu, Ph.D., Protagonist's Chief Scientific Officer.

The content of this press release is solely the views of its authors and does not represent the official views of the National Institutes of Health.

About Protagonist Therapeutics, Inc.

Protagonist Therapeutics is a clinical-stage biopharmaceutical company with a proprietary technology platform which is utilized to discover and develop novel peptide-based drugs to address significant unmet medical needs. Its primary focus is on developing potential first-in-class oral targeted therapy-based peptide drugs that work by blocking biological pathways that are currently targeted by marketed injectable antibody drugs. Protagonist's initial lead peptide product candidates, PTG-100 and PTG-200, are based on this approach, and the company believes these candidates have the potential to transform the existing treatment paradigm for inflammatory bowel disease (IBD), chronic gastrointestinal diseases consisting primarily of ulcerative colitis and Crohn's disease.

PTG-100, a potential first-in-class oral peptide alpha-4-beta-7 integrin antagonist, is currently in a global Phase 2b clinical trial for moderate-to-severe ulcerative colitis.  PTG-200, a potential first-in-class oral Interleukin-23 receptor antagonist for potential treatment of IBD, initially Crohn's disease, is currently in pre-clinical development and is expected to enter Phase 1 clinical studies in the second half of 2017. 

In addition to PTG-100 and PTG-200, the company is developing an injectable hepcidin mimetic PTG-300 as a potential orphan drug for the treatment of rare diseases such as beta-thalassemia.  PTG-300 is currently in pre-clinical development and is expected to enter Phase 1 clinical studies in the second quarter of 2017.

Protagonist is headquartered in Newark, California with its pre-clinical and clinical staff in California, and discovery operations both in California and in Brisbane, Queensland, Australia. For further information, please visit http://www.protagonist-inc.com.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions or current expectations concerning, among other things, the potential for our programs, the timing of the initiation of our clinical trials, the possibility of obtaining orphan drug designation for our product candidates and our potential receipt of funding under the SBIR grant. In some cases, you can identify these statements by forward-looking words such as "anticipate," "believe," "may," "will," "continue," "expect," or the negative or plural of these words or similar expressions.  Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our history of net operating losses, our reliance on third parties and uncertainty regarding our ability to achieve profitability, our ability to develop and commercialize our product candidates, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates.  We discuss many of these risks in greater detail under the heading "Risk Factors" contained in our quarterly report on Form 10-Q for the quarter ended March 31, 2017, filed with the Securities and Exchange Commission on May 10, 2017. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

SOURCE Protagonist Therapeutics, Inc.

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