NEWARK, Calif., May 12, 2021 /PRNewswire/ -- Protagonist
Therapeutics ("Protagonist" or the "Company") (Nasdaq: PTGX), today
announced that an abstract highlighting updated data from its
ongoing Phase 2 clinical study evaluating rusfertide in
polycythemia vera ("PV") has been selected for an oral presentation
at the upcoming European Hematology Association ("EHA") 2021 Annual
Congress. The EHA Congress will take place virtually June 9-17, 2021. Rusfertide, a synthetic,
injectable hepcidin mimetic, regulates iron homeostasis and
controls the absorption, storage, and distribution of iron in the
body. Rusfertide was discovered through the Company's peptide
technology platform.
"We are delighted that our abstract has been selected for an
oral presentation at the EHA Congress," said Sam Saks, M.D., Chief Medical Officer at
Protagonist. "This is an internationally recognized event with
broad attention from the worldwide hematology community. We look
forward to expanding upon our previously reported Phase 2 data in
eighteen patients at the American Society of Hematology meeting,
which demonstrated almost complete elimination of phlebotomy
treatment; reversal of iron deficiency; a decrease of symptom
burden; and maintenance of hematocrit levels below 45 percent, per
guidelines set by the National Comprehensive Cancer Network. We
have recently announced completion of the targeted enrollment of
fifty patients in this ongoing study."
Oral Presentation Details
Title: Rusfertide (PTG-300) Eliminates the Need for
Therapeutic Phlebotomy in Both Low and High-Risk Polycythemia Vera
(PV) Patients
Session: Novel therapies and targets in MPN
Date/Time: Available on-demand starting June 11, 2021 at 9am
CEST
Abstract Number: S200
Presenter: Marina
Kremyanskaya, MD, PhD, Assistant Professor of Medicine,
Hematology and Medical Oncology, at the Icahn School of Medicine at
Mount Sinai
The abstract can be accessed online on the EHA 2021 meeting
library website, ehaweb.org. All presentations will be available on
demand to registered meeting attendees on the EHA virtual Congress
platform as of June 11, 2021.
About Polycythemia Vera
Polycythemia vera (PV) is
a myeloproliferative neoplasm characterized primarily by the
increased production of red blood cells. Well-established treatment
guidelines focus on maintaining hematocrit levels continuously
below 45 percent to reduce the risk of thrombotic events.
Unfortunately, current treatment options are unable to maintain
hematocrit to below the 45 percent target for many patients and may
be associated with serious side effects. PV is a rare disease
affecting approximately 160,000 patients in the U.S., with a
similar prevalence in Europe.
About Protagonist Therapeutics
Protagonist
Therapeutics is a clinical stage biopharmaceutical company
with multiple peptide-based investigational new chemical entities
in different stages of development. Rusfertide (PTG-300) is an
investigational, injectable hepcidin mimetic in a Phase 2
proof-of-concept clinical trial for polycythemia vera, and a
separate Phase 2 clinical study for hereditary hemochromatosis.
Based on the feedback provided by the FDA and EU regulatory
authorities, the Company plans to initiate a single, global, Phase
3 randomized, placebo-controlled trial evaluating the efficacy of a
once weekly, subcutaneously self-administered dose of
rusfertide.
PN-943 is an investigational orally delivered, gut-restricted
alpha-4-beta-7 integrin specific antagonist peptide in a 150
patient Phase 2 study for the potential treatment of inflammatory
bowel disease, with ulcerative colitis as the initial targeted
indication. PTG-200 is an orally delivered, gut-restricted,
interleukin-23 receptor specific antagonist peptide in a Phase 2
clinical trial for Crohn's disease. Two additional
second-generation oral interleukin-23 receptor antagonist
candidates, PN-235 and PN-232, are in early stages of clinical
development. The Company has developed a proprietary technology
platform to discover and develop novel peptide-based therapeutics
to address significant unmet medical needs and transform existing
treatment paradigms. Protagonist is headquartered
in Newark, California. 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, our plans to present updated rusfertide data at EHA
and conduct a Phase 3 trial evaluating rusfertide for PV. 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, 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 Quarterly Report on Form 10-Q for the year ended March 31,
2021, 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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