NEWARK, Calif., Oct. 30, 2019 /PRNewswire/ -- Protagonist
Therapeutics, Inc. (Nasdaq:PTGX) today announced that the first
patient has been dosed in a Phase 2 study of PTG-300 in patients
with polycythemia vera (PV), a myeloproliferative disorder
characterized by overproduction of red blood cells.
"In addition to our ongoing study of PTG-300 in patients with
beta-thalassemia, we are excited to expand its clinical development
with the initiation of this proof-of-concept study in polycythemia
vera," commented Dinesh V. Patel,
Ph.D., Protagonist President and Chief Executive Officer. "An
important aspect of the mechanism of action of the hepcidin mimetic
PTG-300 is to reduce iron availability, which is required to
support the excessive erythropoiesis which occurs in PV, thereby
potentially enabling PTG-300 to manage this excessive
erythropoiesis and ultimately reduce the phlebotomy burden in these
patients."
The Phase 2 study of PTG-300 in PV is designed to monitor the
safety profile and to obtain preliminary evidence of efficacy in
patients requiring phlebotomy. The study is expected to enroll
approximately 30 patients and consists of a 16-week open-label dose
escalation stage every 4 weeks from 10 mg to 80 mg and a 12-week
maintenance period at doses which generate desired hematocrit
levels followed by a 12-week randomized and blinded withdrawal
stage. The study has an open-label extension for up to one year to
monitor long term safety and benefits of the drug. The endpoints of
this clinical proof-of-concept study include measurement of blood
parameters (hematocrit and hemoglobin levels), reductions or delay
in phlebotomy requirements, and improvements in quality-of-life
symptoms. Additional information on the Phase 2 PTG-300 PV study is
available at https://clinicaltrials.gov/ct2/show/NCT04057040.
About PTG-300
PTG -300 is an injectable hepcidin mimetic in clinical
development for the potential treatment of beta-thalassemia and
polycythemia vera. Hepcidin is a natural peptide hormone that
regulates iron absorption and utilization in the body through
sequestration and release from tissue macrophages and intestinal
enterocytes. Iron plays an essential role in various body
functions, especially blood formation. Excess iron in the body is
toxic, resulting in bone marrow, tissue and organ damage over time.
In settings of tissue iron overload and dysregulated
erythropoiesis, treatment with PTG-300 can potentially reduce the
need for phlebotomies, such as in the treatment of PV and
hereditary hemochromatosis, and the need for transfusions and
chelation therapies in thalassemia and MDS. PTG-300 has been
granted Orphan Drug designation in the U.S. and EU and has received
Fast Track designation from the U.S. Food and Drug Administration
for development in the potential treatment of beta-thalassemia.
About Protagonist Therapeutics, Inc.
Protagonist Therapeutics is a clinical stage biopharmaceutical
company that utilizes its proprietary peptide technology platform
to discover and develop novel peptide-based drugs to transform
existing treatment paradigms for patients with significant unmet
medical needs. PTG-300 is an injectable hepcidin mimetic in
development for the treatment of iron overload anemia and related
rare blood diseases. PTG-200 is an oral, gut-restricted
interleukin-23 receptor specific antagonist peptide in clinical
development for the potential treatment of inflammatory bowel
disease. The Company has a worldwide license and collaboration
agreement with Janssen Biotech for the clinical development of
PTG-200 and a Phase 2 study in Crohn's disease is expected to begin
in the fourth quarter of 2019. PN-943 is an oral, gut-restricted
alpha-4-beta-7 integrin specific antagonist peptide in clinical
development for the potential treatment of inflammatory bowel
disease, with ulcerative colitis as the initial intended indication
expected to commence in the first half of 2020.
Protagonist is headquartered in Newark, California. For further information,
please visit http://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 PTG-300 as a
possible treatment for polycythemia vera and beta-thalassemia, the
enrollment of patients in our clinical trials and the outlook for
our other programs. In some cases, you can identify these
statements by forward-looking words such as "will," "expect,"
"potential," 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, 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. 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 three and
six months ended June 30, 2019, 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.