NEWARK, CA / ACCESSWIRE / June 6, 2023 / Protagonist Therapeutics, Inc. (NASDAQ:PTGX) ("Protagonist" or "the Company") today announced that a late-breaking abstract featuring blinded, randomized withdrawal data from the rusfertide (PTG-300) REVIVE Phase 2 study in polycythemia vera (PV) has been accepted for oral presentation at the European Hematology Association (EHA) 2023 Congress:
Targeted Therapy of Uncontrolled Erythrocytosis in Polycythemia Vera with the Hepcidin Mimetic, Rusfertide - Blinded Randomized Withdrawal Results of the REVIVE Study:
- Late Breaking Oral Presentation: Presented by Marina Kremyanskaya, MD, PhD, Icahn School of Medicine at Mount Sinai on Sunday, June 11, 9:45 - 10:00 CEST
As previously announced, EHA will also feature two additional presentations from the Company's rusfertide peptide therapeutic development program, including new data and updates in polycythemia vera.
Rusfertide (PTG-300) Improves (PV)-related Symptoms:
- Presented by Andrew Kuykendall, MD, Moffitt Cancer Center on Friday, June 9, 18:00 - 19:00 CEST
Pharmacokinetic and Pharmacodynamic Effects of Rusfertide in Polycythemia Vera: Results from an Ongoing Phase 2 Study in Patients with Elevated Hematocrit Values:
- Presented by Marina Kremyanskaya, MD, PhD, Icahn School of Medicine at Mount Sinai on Friday, June 9, 18:00 - 19:00 CEST
"We are very pleased to showcase a breadth of data at EHA demonstrating the tremendous promise for rusfertide to change the polycythemia vera treatment paradigm by potentially eliminating the need for phlebotomy, providing improvement of symptoms associated with PV, controlling erythrocytosis and ultimately achieving the treatment goal of maintaining hematocrit under 45% in step with current NCCN and ELN Clinical Practice Guidelines," said Arturo Molina, MD, MS, Chief Medical Officer, Protagonist Therapeutics.
Molina continued, "We look forward to connecting at this year's Congress with dedicated hematology-oncology researchers, patients and advocates as we work together to advance the hepcidin mimetic rusfertide as a selective erythrocytosis controlling agent that can potentially improve how a PV patient feels and functions."
Protagonist Therapeutics is a biopharmaceutical company with peptide-based new chemical entities rusfertide and JNJ-2113 (formerly PN-235) in advanced stages of clinical development, both derived from the Company's proprietary technology platform. Rusfertide, a mimetic of the natural hormone hepcidin, is the Company's lead drug candidate currently in a global Phase 3 stage of development. The REVIVE study is now complete, with an open-label extension underway. The global Phase 3 VERIFY study of rusfertide in polycythemia vera is ongoing. Protagonist retains all worldwide development and commercialization rights to rusfertide.
Positive topline results from the FRONTIER 1 study of JNJ-2113 in moderate-to-severe plaque psoriasis became available in March 2023, with further details to be shared at medical meetings starting in the second quarter of 2023. Advancement of JNJ-2113 into a Phase 3 study and meeting the primary endpoint in that study would qualify Protagonist for milestone payments of $50 million and $115 million, respectively. In total, Protagonist remains eligible for up to $855 million in various milestone payments and tiered royalties based on worldwide net drug sales.
More information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at 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 the potential benefits to patients of rusfertide. 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 Biotech, 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 most recently filed periodic reports on Form 10-K and Form 10-Q 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.