NEWARK, Calif., Nov. 4, 2021 /PRNewswire/ -- Protagonist
Therapeutics, Inc. (Nasdaq: PTGX) ("Protagonist" or "the Company")
today announced that two abstracts highlighting updated data from
its Phase 2 study of rusfertide in polycythemia vera (PV) have been
selected for oral presentations at the American Society of
Hematology (ASH) 2021 Annual Meeting taking place December 11-14, 2021. An additional three
abstracts on rusfertide in PV and hereditary hemochromatosis (HH)
have been accepted as poster presentations at ASH.
"We are delighted to have the opportunity to present further
evidence of rusfertide's potential to improve outcomes in
polycythemia vera and other diseases related to iron
dysregulation," said Dinesh V.
Patel, PhD, President and Chief Executive Officer of
Protagonist. "Data included in these oral presentations will
provide important new information about how rusfertide may reduce
the need for phlebotomy and control hematocrit levels and symptoms
for patients suffering from PV. The data we share at ASH this year
will serve as a valuable springboard for further advancement of our
rusfertide clinical programs, including the initiation of a Phase 3
clinical trial of rusfertide in PV in the first quarter of
2022."
Details for ASH 2021 oral presentations are as
follows:
Title: "Rusfertide (PTG-300) Controls Hematocrit Levels
and Essentially Eliminates Phlebotomy Requirement in Polycythemia
Vera Patients"
Session Title: 634. Myeloproliferative Syndromes: Clinical
and Epidemiological: Novel Therapies for MPNs and JAK inhibitors
for Myelofibrosis
Presentation Type: Oral
Presentation Date and Time: Sunday,
December 12, 2021/Session Time: 9:30
AM - 11:00 AM/Presentation Time: 10:15 AM
Authors: Ronald Hoffman, MD,
Marina Kremyanskaya, MD, PhD,
Yelena Ginzburg, MD, Andrew Kuykendall, MD, Naveen Pemmaraju, MD, Abdulraheem Yacoub, MD,
Jay Yang, MD, Suneel Gupta, PhD, Frank
Valone, MD, Sarita Khanna,
PhD and Srdan Verstovsek, MD, PhD
Title: "Rusfertide (PTG-300) Induction Therapy Rapidly
Achieves Hematocrit Control in Polycythemia Vera Patients without
the Need for Therapeutic Phlebotomy"
Session Title: 634. Myeloproliferative Syndromes: Clinical
and Epidemiological: Novel Therapies for MPNs and JAK inhibitors
for Myelofibrosis
Presentation Type: Oral
Presentation Date and Time: Session Date: Sunday, December 12, 2021/Session Time:
9:30 AM - 11:00 AM/Presentation Time:
10:45 AM
Authors: Yelena Ginzburg, MD,
Kamini Kirubamoorthy, Sinari Salleh, MD, Sung-Eun Lee, MD, PhD, Jae Hoon Lee, MD, PhD, Veena Selvaratnam, MD, Suneel K Gupta, PhD,
Frank Valone, MD, Sarita Khanna, PhD, Nishit Modi, PhD, Ronald
Hoffman, MD and Lee Ping
Chew, MD
Additional details for ASH 2021 poster presentations are as
follows:
Title: "A Phase 3 Study of the Hepcidin Mimetic
Rusfertide (PTG-300) in Patients with Polycythemia Vera"
Session Title: 634. Myeloproliferative Syndromes: Clinical
and Epidemiological: Poster I
Presentation Type: Poster
Presentation Date and Time: Saturday,
December 11, 2021/Presentation Time: 5:30 PM - 7:30 PM
Authors: Srdan Verstovsek, MD, PhD, Andrew Kuykendall, MD, Ronald Hoffman, MD, Yelena Ginzburg, MD, Naveen Pemmaraju, MD, Frank Valone, MD, Nishit
Modi, PhD, Sarita Khanna,
PhD, Paula G O'Connor, MD, Suneel K Gupta, PhD and Jean-Jacques Kiladjian, MD, PhD
Title: "Regulation of Iron Homeostasis and Efficacy of
Rusfertide Analog Peptide in a Mouse Model for Polycythemia
Vera"
Session Title: 102. Iron Homeostasis and Biology: Poster
II
Presentation Type: Poster
Presentation Date and Time: Sunday,
December 12, 2021/Presentation Time: 6:00 PM - 8:00 PM
Authors: Roopa Taranath, PhD,
Li Zhao, MD, PhD, Jayanthi Vengalam,
MS, Lawrence Lee, BS,
Tenny Tang, MS, Celino Dion, Ahu Su, BS, James Tovera, BS, Ashok
Bhandari, PhD,
Xiaoli Cheng, PhD, Larry Mattheakis,
PhD and David Y Liu, PhD
Title: "Rusfertide (PTG-300), a Hepcidin Mimetic,
Maintains Liver Iron Concentration in the Absence of Phlebotomies
in Patients with Hereditary Hemochromatosis"
Session Title: 102. Iron Homeostasis and Biology: Poster
I
Presentation Type: Poster
Presentation Date and Time: Date: Saturday, December 11, 2021/Presentation Time:
5:30 PM -7:30 PM
Authors: Kris V. Kowdley, MD,
Nishit B Modi, PhD, Frank Valone,
MD, Victor Priego, MD, Christopher Ferris, MD, PhD, Frank Cole, MD, and Suneel Gupta, PhD
Full abstracts can be found on the ASH website at
https://www.hematology.org/meetings/annual-meeting/abstracts
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. 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 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.
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