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Protagonist Therapeutics Expands Intellectual Property Portfolio

September 6, 2018 7:00 AM

NEWARK, Calif., Sept. 6, 2018 /PRNewswire/ -- Protagonist Therapeutics, Inc. (NASDAQ: PTGX) today announced that three new U.S. patents have been issued that strengthen intellectual property protection for its novel peptide clinical drug candidates PTG-200 and PTG-300. Issued U.S. Patents No. 10,023,614 and 10,035,824 provide protection applicable to PTG-200, an orally stable interleukin-23 receptor (IL-23R) antagonist, and its analogs in co-development with Janssen Biotech for inflammatory bowel diseases. U.S. Patent No. 10,030,061 provides coverage related to the hepcidin mimetic PTG-300 and analogs in the treatment or prevention of iron overload diseases and other conditions.

"These new patents demonstrate the broad range of our technology platform, which allows discovery of both oral and injectable peptide therapeutics to address unmet needs in diverse areas ranging from gastrointestinal (GI) diseases to blood disorders," commented Dinesh Patel, Ph.D., President and Chief Executive Officer of Protagonist. "The ability to discover novel clinical drug candidates in a de novo fashion with design characteristics relevant to specific clinical needs, such as the oral, GI-restricted clinical drug candidate PTG-200 and the injectable hepcidin analogue PTG-300, is a defining and expanding feature of the Protagonist's peptide technology platform."

About Protagonist Therapeutics, Inc.

Protagonist Therapeutics is a clinical stage biopharmaceutical company that utilizes a proprietary technology platform to discover and develop novel peptide-based drugs to transform existing treatment paradigms for patients with significant unmet medical needs. PTG-100 is an oral alpha-4-beta-7 integrin antagonist peptide that is under development for potential treatment of inflammatory bowel diseases. The company's interleukin-23 receptor antagonist peptide, PTG-200, is currently in a Phase 1 clinical trial in healthy volunteers to support a Phase 2 study in Crohn's disease. The IL-12/23 pathway blockade is an approach that has been validated through an FDA-approved injectable antibody drug. The company has entered into a worldwide license and collaboration agreement with Janssen Biotech for the clinical development of PTG-200. Protagonist has also applied its innovative peptide platform outside of gastrointestinal disease areas and is developing an injectable hepcidin mimetic, PTG-300, for the potential treatment of anemia and iron overload related to rare blood diseases with an initial focus on beta-thalassemia. The company has completed a Phase 1 clinical trial of PTG-300, which established pharmacodynamic-based clinical proof-of-concept in normal healthy volunteers. The U.S. Food and Drug Administration has granted Orphan Drug Designation to PTG-300 for beta-thalassemia for which a global Phase 2 trial is to be initiated in the fourth quarter of 2018. Treatment of patients with myelodysplastic syndromes, hereditary hemochromatosis and polycythemia vera represent additional opportunities for future development of PTG-300.

Protagonist is headquartered in Newark, California, with pre-clinical and clinical staff in California and discovery operations in both California and 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, our research and development plans, the utility of our intellectual property, and the adequacy of our capital resources. In some cases, you can identify these statements by forward-looking words such as "anticipate," "believe," "may," "will," "would," or "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 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 three months ended June 30, 2018 as filed with the Securities and Exchange Commission. 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.

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SOURCE Protagonist Therapeutics, Inc.

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