Protagonist Therapeutics Announces Data from Phase 2 Rusfertide Study in Hereditary Hemochromatosis Selected for Oral Presentation at the Annual AASLD Meeting
"We are pleased to have this opportunity to share new data on rusfertide that establishes clinical proof-of-concept in hereditary hemochromatosis," said
Details for the AASLD 2021 oral presentation are as follows:
Title: "An Open-Label Phase 2, Dose-Finding Study of the Safety and Efficacy of Rusfertide (PTG-300), a Hepcidin Mimetic, in Patients with Hereditary Hemochromatosis."
Session Title: Parallel 3: Metabolic and Genetic Disease: Hemochromatosis, Wilsons Disease, Alpha-1 Antitrypsin Deficiency
Presentation Type: Oral, Parallel Session
Presentation Date and Time:
Authors: Kris V Kowdley, MD, FACP, FACG, AGAF, FAASLD, Dr.
The full abstract can be found in the October supplement of Hepatology, the peer-reviewed journal of AASLD, and on the AASLD website at https://www.aasld.org/the-liver-meeting/open-label-phase-2-dose-finding-study-safety-and-efficacy-rusfertide-ptg-300.
As previously announced on
About Hereditary Hemochromatosis
Hereditary hemochromatosis (HH) is a metabolic disorder caused by gene mutations that alter proteins responsible for regulating iron absorption, resulting in iron overload.1 The most common form of HH, hemochromatosis type 1, is characterized by defects in the HFE gene that lead to deficient levels of hepcidin in the body.2 While there are nearly 1 million people in the
Rusfertide (PTG-300) is an investigational, injectable hepcidin mimetic that is currently being developed for various disorders associated with iron overload and/or excessive erythrocytosis (red blood cell production). Rusfertide regulates iron homeostasis and controls the absorption, storage, and distribution of iron in the body. Discovered through Protagonist's peptide technology platform, rusfertide is currently being evaluated in a small open-label Phase 2 study in hereditary hemochromatosis (HH), which arises primarily from absence or deficiency of the hepcidin pathway. In addition, rusfertide is also being investigated in a Phase 2 study in polycythemia vera (PV), a rare chronic blood disorder that affects about 160,000 patients in the
About Protagonist Therapeutics
Protagonist Therapeutics is a biopharmaceutical company with multiple peptide-based investigational new chemical entities in different stages of development, all derived from the Company's proprietary technology platform. Protagonist's pipeline includes rusfertide (PTG-300), an investigational, injectable hepcidin mimetic which is currently in Phase 2 development for the treatment of polycythemia vera and hereditary hemochromatosis. As announced on
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 Company's clinical development program for rusfertide and the clinical hold on the Company's rusfertide clinical trials. 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, the impact of the clinical hold on the our rusfertide clinical development program, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreements, 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.
3 Decision Resources Group.
5 National Organization for Rare Disorders.
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