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 MeetingĀ® 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 MeetingĀ® 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
10-15% of these patients exhibit clinical manifestations of
hemochromatosis type 1.3 These patients absorb excess
amounts of iron from their diet, eventually resulting in iron
accumulation in various organs of the body, which can lead to organ
disease and failure.4 Phlebotomy is the most common
method of reducing iron levels; however, there are currently no
approved treatments for HH.5
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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