Protagonist Therapeutics Announces Removal of FDA Clinical Suspension on Rusfertide Clinical Development Program



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All ongoing clinical trials of rusfertide to resume dosing

Phase 3 registration trial set to begin in Q1 2022

Conference call scheduled for today at 8:00 a.m.ET

NEWARK, Calif., October 11, 2021 / PRNewswire / – Protagonist Therapeutics, Inc. (Nasdaq: PTGX) (“Protagonist” or “the Company”) today announced that the United States Food and Drug Administration (FDA) has lifted the full clinical suspension of Company’s rusfertide clinical studies, announced on September 17, 2021. According to the FDA, the dosage in all clinical studies of rusfertide can be resumed.

The Company has provided the FDA with all requested information as a basis for a full response and subsequent removal of the clinical suspension. In particular, the Company provided the requested individual clinical safety reports for patients, updated the investigator brochure and patient informed consent forms, performed a comprehensive review of the safety database more recent and included new safety and shutdown rules in study protocols. The Company is working closely with study investigators and clinical trial sites to resume patient dosing in ongoing clinical trials with rusfertide after patients have re-consented.

The clinical suspension was initially triggered by a recent non-clinical finding in a 26-week-old rasH2 transgenic mouse model indicating benign and malignant subcutaneous skin tumors. The rasH2 signal also prompted a re-examination of the four cancer cases seen in all rusfertide clinical trials involving more than 160 patients, and a comprehensive review of the safety database, including cases of unexpected serious adverse reactions. suspected (SUSAR). No additional cancer cases, and no other unexpected safety signals, surfaced during this process.

“We are extremely pleased that the FDA has acted so quickly to lift the clinical blockade of the rusfertide development program, allowing us to resume dosing of patients in our clinical studies,” said Dinesh patel, Doctorate., President and CEO of Protagonist. “Patient safety continues to be our top priority. We believe that the cumulative evidence regarding the clinical safety and risk-benefits of rusfertide supports accelerated clinical development. We are actively preparing to launch the Phase 3 registration study for quarterly 2022 polycythemia. Protagonist will continue to work closely with the FDA to ensure patient safety with modifications to current and future studies planned with the rusfertide. We remain optimistic about the future potential of rusfertide to address unmet medical needs in excessive erythrocytosis and iron overload related diseases such as polycythemia vera and inherited hemochromatosis, respectively. “

Conference Call and Webcast Information

A conference call will be held today, October 11, 2021, To 8:00 am ET.

Live audio of the conference call will be broadcast simultaneously over the Internet. The call will be accessible to investors, members of the media and the general public.

To access the live call, dial (877) 870-4263 (US /Canada) or (412) 317-0790 (international) five minutes before the call and ask to be reached on the Protagonist Therapeutics call. A live and archived webcast will be available in the Investors section of the Company’s website at www.protagonist-inc.com.

About Protagonist Therapeutics

Protagonist Therapeutics is a biopharmaceutical company with several new experimental chemical entities based on peptides at different stages of development, all derived from the Company’s proprietary technology platform. The lead pipeline includes rusfertide (PTG-300), an experimental injectable hepcidin mimetic in a phase 2 proof-of-concept clinical trial for polycythemia vera (PV), a phase 2 study in PV subjects with elevated hematocrit levels; and a phase 2 study of hereditary hemochromatosis.

The Company is also evaluating a specific oral restricted alpha-4-beta-7 integrin antagonist peptide (PN-943) currently in a phase 2 study in adults with moderate to severe active ulcerative colitis (UC). The Company targets ulcerative colitis as an initial indication.

The Company has a worldwide licensing and collaboration agreement with Janssen Biotech, Inc., for the development of oral peptide IL-23 receptor antagonists. The compounds included in this agreement are PTG-200, PN-235 and PN-232. PTG-200 is an orally administered interleukin-23 receptor specific antagonist peptide in a phase 2 clinical trial for Crohn’s disease. PN-235 and PN-232, two second generation oral interleukin-23 receptor antagonist candidates, are currently in phase 1 studies.

Protagonist is headquartered in Newark, California. For more information, please visit www.protagonist-inc.com.

Caution regarding forward-looking statements

This press release contains forward-looking statements for the purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our current intentions or expectations regarding, among other things, the company’s clinical development program. for rusfertide. . In some cases, you may identify such statements by forward-looking words such as “anticipate”, “believe”, “could”, “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 collaborative arrangements, the impact of the current COVID-19 pandemic on our discovery and development efforts, our ability to use and to expand our programs to create a pipeline of product candidates, our ability to obtain and maintain regulatory approval for our product candidates, our ability to operate in a competitive industry and to compete successfully with more resourced competitors. that we do, and our ability to obtain and adequately protect the intellectual property rights of our product candidates. Additional information regarding 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 latest periodic reports filed on the forms. 10-K and 10- Q filed with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual operating results, financial condition and liquidity, as well as the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. . All forward-looking statements 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.

Protagonist Therapeutics, Inc. (PRNewsFoto / Protagonist Therapeutics, Inc.)

Protagonist Therapeutics, Inc. (PRNewsFoto / Protagonist Therapeutics, Inc.)

Cision

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SOURCE Protagonist Therapeutics, Inc.

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