NEWARK, Calif., Dec. 6, 2020 /PRNewswire/ -- Protagonist
Therapeutics, Inc. (Nasdaq:PTGX) today announced additional updated
results from the ongoing Phase 2 study of PTG-300 in patients with
polycythemia vera (PV), demonstrating dramatic decreases in the
need for therapeutic phlebotomy in patients with PV, while
maintaining control over blood hematocrit levels. The data were
presented in an oral presentation today at the 62nd
American Academy of Hematology annual meeting, being held
December 5-8, 2020.
"These results provide strong support for the potential for
PTG-300 to improve on standards of care, not only for our patients
receiving frequent phlebotomy but also for our patients who
continue to receive phlebotomies in combination with other
treatments," commented Andrew
Kuykendall, M.D., study investigator and member of the
Department of Malignant Hematology at the Moffitt Cancer Center.
"Clinicians face significant challenges in appropriately managing
hematocrit with current options, particularly in those patients who
require frequent phlebotomies. The ability of PTG-300 to provide
consistent, long term control of hematocrit and improve iron
deficiency suggests that this approach could become an important
treatment option for many patients across broad categories of
patient populations."
Summary of Results
- Of the 18 PV patients treated with PTG-300, the vast majority
were able to eliminate therapeutic phlebotomies and maintain a
target hematocrit level of less than 45 percent.
- Treatment with PTG-300 was also shown to reverse iron
deficiency, a serious side effect of regular therapeutic
phlebotomies as a treatment for PV.
- Early observations suggest a decreased symptom burden over
time, including overall burden (MPN-TSS), as well as measurements
specific to mental function, fatigue and itching.
- Administration of PTG-300 was well tolerated, with injection
site reactions and bruise as the only observed adverse events.
"We are very pleased with the study results obtained to date in
controlling hematocrit with PTG-300, which mimics the mechanism of
the natural hormone hepcidin in the body," commented Sam Saks,
M.D., Chief Medical Officer of Protagonist. "We look forward to
sharing these compelling data with U.S. and EU regulatory
authorities in the first half of 2021 and to work toward alignment
on the design of a pivotal trial in polycythemia vera. Complete
enrollment of 50 patients in this Phase 2 study is expected in
mid-2021."
The ongoing Phase 2 PTG-300 polycythemia vera study is designed
to monitor the safety profile and obtain evidence of efficacy in
approximately 50 patients requiring frequent phlebotomies (at least
three phlebotomies in prior six months). The study design consists
of three stages: a 16-week open-label stage with dose escalation,
reduction, or maintenance every four weeks from 10 mg to 80 mg by
subcutaneous administration at weekly intervals, a 12-week
maintenance period at doses that generate desired hematocrit
levels, and then a randomized and blinded withdrawal stage (1:1
treatment vs. placebo) for up to 12 weeks. The study also has an
open-label extension for up to one year to monitor long-term safety
and other effects. The primary endpoint is the control of
hematocrit below 45 percent during the blinded randomized
withdrawal period. Other endpoints of this clinical
proof-of-concept study include measurement of blood parameters
(hematocrit and hemoglobin levels), reductions or delay in
phlebotomy requirements, and symptoms related to quality of
life.
Additional information is available at
https://clinicaltrials.gov/ct2/show/NCT04057040 and
http://ptg300pvstudy.com/.
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 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.