Protagonist Therapeutics Announces Data from Phase 2 Rusfertide Study in Hereditary Hemochromatosis Selected for Oral Presentation at the Annual AASLD Meeting
Protagonist Therapeutics announced that an abstract from its Phase 2 study of rusfertide in hereditary hemochromatosis has been selected for oral presentation at The Liver Meeting® 2021. The presentation will take place on November 13, 2021, highlighting clinical proof-of-concept for rusfertide. However, all rusfertide studies are currently on clinical hold imposed by the FDA, and the company is in discussions to determine future steps for the development program. This situation raises concerns about the product's advancement in the market.
- Abstract from Phase 2 study of rusfertide selected for oral presentation at The Liver Meeting® 2021.
- Presentation emphasizes clinical proof-of-concept in hereditary hemochromatosis.
- All rusfertide studies are on clinical hold by the FDA, affecting development.
NEWARK, Calif., Oct. 4, 2021 /PRNewswire/ -- Protagonist Therapeutics, Inc. (Nasdaq: PTGX) ("Protagonist" or "the Company") today announced that an abstract highlighting new results from its Phase 2 study of rusfertide in hereditary hemochromatosis (HH) has been selected for oral presentation at The Liver Meeting® 2021, hosted by the American Association for the Study of Liver Diseases (AASLD), taking place virtually November 12-15, 2021.
"We are pleased to have this opportunity to share new data on rusfertide that establishes clinical proof-of-concept in hereditary hemochromatosis," said Dinesh Patel, Ph.D., President and Chief Executive Officer of Protagonist. "We are especially pleased and honored that this data has been selected by AASLD for an oral presentation. The Liver Meeting® brings together the world's most esteemed experts in hepatology."
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: Saturday, November 13, 2021, 10 a.m. PT
Authors: Kris V Kowdley, MD, FACP, FACG, AGAF, FAASLD, Dr. Nishit Modi, Dr. Frank Valone, Dr. Victor Priego, Dr. Frank Cole, Dr. Joe Pouzar and Dr. Suneel Gupta
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 September 17, 2021, Protagonist's rusfertide clinical trials have been placed on clinical hold by the U.S. Food and Drug Administration (FDA). Protagonist is working closely with the FDA to determine next steps for the rusfertide development program.
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 U.S. estimated to be carriers of the mutations, approximately 10
About Rusfertide
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 U.S. As announced on September 17, 2021, all rusfertide studies are currently placed on clinical hold per a decision of the U.S. Food and Drug Administration.
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 September 17, 2021, all rusfertide studies are currently placed on clinical hold per a decision of the U.S. Food and Drug Administration. The Company is also evaluating an orally delivered, gut-restricted alpha-4-beta-7 integrin specific antagonist peptide (PN-943) currently in a Phase 2 study in adults with moderate to severe active ulcerative colitis (UC). The Company is targeting ulcerative colitis as the initial indication. In addition, Protagonist has a worldwide license and collaboration agreement with Janssen Biotech, Inc., for the development of oral peptide IL-23 receptor antagonists. Compounds included in this agreement are PTG-200, PN-235 and PN-232. PTG-200 is an orally delivered interleukin-23 receptor specific antagonist peptide which is currently in Phase 2 development for Crohn's disease. PN-235 and PN-232, both second-generation oral interleukin-23 receptor antagonist candidates, are currently in Phase 1 studies. 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 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.
1 Hemochromatosis.org, National Organization for Rare Disorders.
2 Hemochromatosis.org, National Organization for Rare Disorders.
3 Decision Resources Group.
4 Hemochromatosis.org.
5 National Organization for Rare Disorders.
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