NEWARK, Calif., Dec. 7, 2020 /PRNewswire/ -- Protagonist
Therapeutics, Inc. (Nasdaq:PTGX) today announced the results of a
large-scale analysis of real world treatment patterns for
polycythemia vera, demonstrating that treatment incorporating
existing options failed to achieve hematocrit control for a
majority of patients and across broad categories of patient groups
over the course of two years of observations. The analysis included
patients in both high risk and low risk groups, as well as patients
receiving phlebotomy alone or phlebotomy as a component of
combination treatment. Details will be presented today at the
American Society for Hematology (ASH) 2020 annual meeting.
"This analysis shows that patients with polycythemia vera are
often not receiving appropriate treatment, thereby potentially
exposing these patients to life-threatening risks such as the risk
of experiencing thrombotic events," commented Srdan Verstovsek,
M.D, Ph.D., research co-author and Director of the Clinical
Research Center for Myeloproliferative Neoplasms at the MD Anderson
Cancer Center. "Improving treatment patterns would likely help
avoid risks, improve quality of life, and potentially avoid
unnecessarily utilization of health care resources associated with
adverse outcomes."
The large scale analysis with 4,264 patients analyzed indicated
that only 22 percent of a representative population of patients had
hematocrit values maintained below the NCCN recommended guideline
level of 45 percent. A majority of patients in the high risk
population received treatment with phlebotomy alone, and hematocrit
levels were often above recommended levels, and nearly half (49
percent) of patients had hematocrit levels substantially above
recommended levels (above 50 percent) at least once during the
observation period. Consistent with inadequate hematocrit control,
a high incidence of thrombotic events was observed in patients
receiving treatment.
"Our interpretation of these results is that there is a
significant unmet need for effective treatment options for patients
with polycythemia vera," commented Samuel
Saks, M.D., Protagonist Chief Medical Officer. "Patients are
being poorly treated, resulting in excessive risk."
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.
Conference Call and Webcast Information
Protagonist management will host a conference call at
8:30 a.m. EST on December 9, 2020, to provide a research update
including Andrew Kuykendall, M.D.,
PTG-300 study investigator and member of the Department of
Malignant Hematology at the Moffitt Cancer Center. To access the
call, dial 1-844-515-9178 (U.S./Canada) or 1-614-999-9313 (international) and
refer to conference ID number 8794865. A live and archived webcast
will also be accessible in the Investors section of the Company's
website at www.protagonist-inc.com.
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 benefits of
polycythemia vera treatments. 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.