NEWARK, Calif., Dec. 2, 2020 /PRNewswire/ -- Protagonist
Therapeutics, Inc. (Nasdaq:PTGX) today announced that the U.S. Food
and Drug Administration (FDA) has granted Fast Track designation to
PTG-300 in the treatment of polycythemia vera, a rare disease
characterized by the excessive production of red blood cells.
PTG-300 is an injectable synthetic peptide mimetic of the natural
hormone hepcidin that has demonstrated the ability to dramatically
decrease the requirement for phlebotomy in an ongoing Phase 2 study
in polycythemia vera patients. PTG-300 has previously received
orphan drug designation for the treatment of polycythemia vera from
the U.S. FDA.
"Fast Track designation reflects the potential for PTG-300 to
improve upon the treatments that are currently available for
patients with polycythemia vera, and provides opportunities to
substantially accelerate clinical development," commented
Dinesh V. Patel, Ph.D., Protagonist
President and Chief Executive Officer. "We continue to enroll and
treat patients in our ongoing Phase 2 study, with complete
enrollment expected in mid-2021. We look forward to working closely
with the FDA to discuss and finalize a pivotal program in the first
half of 2021."
The FDA Fast Track Program is designed to facilitate the
development and expedite the review of new therapeutics that are
intended to treat serious conditions and that demonstrate the
potential to address unmet medical needs. Drugs that receive this
designation benefit from more frequent interactions and meetings
with the FDA and potential pathways for expedited approval.
A Phase 2 study of PTG-300 in patients with polycythemia vera is
currently enrolling subjects. Additional information is available
at http://ptg300pvstudy.com/.
About Polycythemia Vera
Polycythemia vera 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.
There are an estimated 100,000 patients with polycythemia vera in
the U.S. and approximately 100,000 patients in major EU
countries.
About Protagonist Therapeutics, Inc.
Protagonist Therapeutics is a clinical stage biopharmaceutical
company that utilizes a proprietary technology platform to discover
and develop novel peptide-based therapeutics to address significant
unmet medical needs and transform existing treatment paradigms for
patients. PTG-300 is an injectable hepcidin mimetic in development
for the treatment of polycythemia vera and other blood disorders.
PTG-200 is an orally delivered, gut-restricted, interleukin-23
receptor specific antagonist peptide in development for the
treatment of inflammatory bowel disease, with Crohn's disease as
the initial indication. In addition to PTG-200, two oral peptide
interleukin-23 receptor antagonist candidates from a collaboration
with Janssen Biotech, Inc., are in development and have been
selected for advancement into clinical studies. PN-943 is an orally
delivered, gut-restricted alpha-4-beta-7 integrin specific
antagonist peptide in development for the treatment of inflammatory
bowel disease, with ulcerative colitis as the initial targeted
indication.
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, the potential of our product
candidates to improve upon available therapies and our expectations
regarding our interactions with regulatory authorities and the
timing of the enrollment in our clinical trial. 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 quarter ended September 30, 2020, 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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SOURCE Protagonist Therapeutics, Inc.