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Protagonist Announces Results of Large-Scale Analysis of Current Treatment Patterns Revealing Significant Opportunity to Improve the Standard of Care for Patients with Polycythemia Vera Across Broad Population Categories

-- Treatment options did not provide hematocrit control consistent with NCCN guidelines for up to 78 percent of patients as presented at the American Society for Hematology (ASH) 2020 annual meeting --
-- Company to host conference call to provide research update on December 9, 2020, at 8:30 a.m. EST --

NEWARK, Calif., Dec. 7, 2020 /PRNewswire/ -- Protagonist Therapeutics, Inc. (Nasdaq:PTGX) today announced the results of a large-scale analysis of real world treatment patterns for polycythemia vera, demonstrating that treatment incorporating existing options failed to achieve hematocrit control for a majority of patients and across broad categories of patient groups over the course of two years of observations. The analysis included patients in both high risk and low risk groups, as well as patients receiving phlebotomy alone or phlebotomy as a component of combination treatment. Details will be presented today at the American Society for Hematology (ASH) 2020 annual meeting.

"This analysis shows that patients with polycythemia vera are often not receiving appropriate treatment, thereby potentially exposing these patients to life-threatening risks such as the risk of experiencing thrombotic events," commented Srdan Verstovsek, M.D, Ph.D., research co-author and Director of the Clinical Research Center for Myeloproliferative Neoplasms at the MD Anderson Cancer Center. "Improving treatment patterns would likely help avoid risks, improve quality of life, and potentially avoid unnecessarily utilization of health care resources associated with adverse outcomes."

The large scale analysis with 4,264 patients analyzed indicated that only 22 percent of a representative population of patients had hematocrit values maintained below the NCCN recommended guideline level of 45 percent. A majority of patients in the high risk population received treatment with phlebotomy alone, and hematocrit levels were often above recommended levels, and nearly half (49 percent) of patients had hematocrit levels substantially above recommended levels (above 50 percent) at least once during the observation period. Consistent with inadequate hematocrit control, a high incidence of thrombotic events was observed in patients receiving treatment.

"Our interpretation of these results is that there is a significant unmet need for effective treatment options for patients with polycythemia vera," commented Samuel Saks, M.D., Protagonist Chief Medical Officer. "Patients are being poorly treated, resulting in excessive risk."

A Phase 2 study of PTG-300 in patients with polycythemia vera is currently enrolling subjects. Additional information is available at http://ptg300pvstudy.com/.

About Polycythemia Vera

Polycythemia vera is a myeloproliferative neoplasm characterized primarily by the increased production of red blood cells. Well-established treatment guidelines focus on maintaining hematocrit levels continuously below 45 percent to reduce the risk of thrombotic events. Unfortunately, current treatment options are unable to maintain hematocrit to below the 45 percent target for many patients and may be associated with serious side effects. There are an estimated 100,000 patients with polycythemia vera in the U.S. and approximately 100,000 patients in major EU countries.

Conference Call and Webcast Information

Protagonist management will host a conference call at 8:30 a.m. EST on December 9, 2020, to provide a research update including Andrew Kuykendall, M.D., PTG-300 study investigator and member of the Department of Malignant Hematology at the Moffitt Cancer Center. To access the call, dial 1-844-515-9178 (U.S./Canada) or 1-614-999-9313 (international) and refer to conference ID number 8794865. A live and archived webcast will also be accessible in the Investors section of the Company's website at www.protagonist-inc.com.

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 therapeutics to address significant unmet medical needs and transform existing treatment paradigms for patients. PTG-300 is an injectable hepcidin mimetic in development for the treatment of polycythemia vera and other blood disorders. PTG-200 is an orally delivered, gut-restricted, interleukin-23 receptor specific antagonist peptide in development for the treatment of inflammatory bowel disease, with Crohn's disease as the initial indication. In addition to PTG-200, two oral peptide interleukin-23 receptor antagonist candidates from a collaboration with Janssen Biotech, Inc., are in development and have been selected for advancement into clinical studies. PN-943 is an orally delivered, gut-restricted alpha-4-beta-7 integrin specific antagonist peptide in development for the treatment of inflammatory bowel disease, with ulcerative colitis as the initial targeted indication.

Protagonist is headquartered in Newark, California. For further information, please visit 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 benefits of polycythemia vera treatments. In some cases, you can identify these statements by forward-looking words such as "anticipate," "believe," "may," "will," "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 earn milestone payments under our collaboration agreement with Janssen, the impact of the current COVID-19 pandemic on our discovery and development efforts, 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. Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading "Risk Factors" contained in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, 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.

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