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Key Patent is Issued Covering Protagonist Therapeutics' Alpha4Beta7 Integrin Peptide Inhibitors including Oral Drug Candidate PTG-100

MILPITAS, Calif., Jan. 5, 2017 /PRNewswire/ -- Protagonist Therapeutics, Inc. (NASDAQ: PTGX) today announced that a key patent has issued covering orally stable peptides from the company's most advanced development program. This new U.S. patent, No. 9,518,091, together with previously granted U.S. patent No. 9,273,093, provides protection for the company's alpha4beta7 integrin peptide inhibitors, which includes the company lead clinical candidate, PTG-100.

"This new patent provides intellectual property coverage until 2035 for our orally stable alpha4beta7 integrin peptide inhibitors," said Dinesh V. Patel, Ph.D., Protagonist President and Chief Executive Officer. "We are very enthusiastic about this program and look forward to reporting on continued progress in clinical development of our lead oral drug candidate PTG-100 for potential treatment of inflammatory bowel diseases."

About PTG-100

PTG-100 is a potential first-in-class oral, alpha4beta7 integrin-specific antagonist peptide product candidate which has now completed a Phase 1 clinical trial in normal healthy volunteers (NHVs), and is being developed initially for potential treatment of moderate-to-severe ulcerative colitis (UC). Alpha4beta7 integrin is considered to be one of the most gastrointestinal-specific biological targets for inflammatory bowel disease due to its binding to MAdCAM-1, an extracellular protein that resides mostly in the gastrointestinal (GI) vasculature.

About Protagonist Therapeutics

Protagonist Therapeutics is a clinical-stage biopharmaceutical company with a proprietary technology platform focused on discovering and developing peptide-based new chemical entities to address significant unmet medical needs. Its primary focus is on developing first-in-class oral peptide drugs that specifically target biological pathways also targeted by currently marketed injectable antibody drugs. Compared to injectable antibody drugs, Protagonist's oral peptides offer targeted delivery to the GI tissue compartment, potential for improved safety due to minimal exposure in the blood, improved convenience and compliance, and potentially an opportunity for earlier introduction of targeted therapy for inflammatory bowel disease (IBD). Protagonist's initial lead peptide product candidates, PTG-100 and PTG-200, are based on this approach, and the company believes they have the potential to transform the existing treatment paradigm for IBD, a GI disease consisting primarily of ulcerative colitis and Crohn's disease.

PTG-100, a potential first-in-class oral alpha4beta7 integrin antagonist that is being developed initially for moderate-to-severe ulcerative colitis, has now completed a phase 1 clinical trial in normal healthy volunteers.  PTG-200, a potential first-in-class oral Interleukin-23 receptor antagonist is being developed initially for moderate-to-severe Crohn's disease and is currently in IND-enabling studies.

The company has a peptide technology platform that enables the discovery of oral and injectable peptides that can be utilized against a diverse set of targets and diseases including, but not confined to the GI. In addition to PTG-100 and PTG-200, the company is engaged in the discovery and development of injectable hepcidin mimetics, including one lead compound from this program, PTG-300, which is currently in pre-clinical development. These mimetics have potential utility for the treatment of iron overload disorders, such as beta-thalassemia and hereditary hemochromatosis (HH), each of which may qualify PTG-300 for orphan drug designation.  

Protagonist is headquartered in Milpitas, 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, plans, timing and the availability of results of our clinical trials and the potential for eventual regulatory approval of our product candidates. In some cases you can identify these statements by forward-looking words such as "may," and "continue,"   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 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 inability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, our reliance on third parties, 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 September 30, 2016 to be filed with the Securities and Exchange Commission. 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.

 

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SOURCE Protagonist Therapeutics, Inc.

Joan Kureczka, Kureczka/Martin Associates, Tel: +1 415-821-2413, Mobile: +1-415-690-0210, email: Joan@Kureczka-martin.com, OR For Investors, The Trout Group, Gitanjali Jain Ogawa, Tel: +1 646-378-2949, gogawa@troutgroup.com