NEWARK, Calif., Dec. 14, 2017 /PRNewswire/ -- Protagonist
Therapeutics, Inc. (Nasdaq: PTGX) today announced final top-line
results from the randomized, placebo-controlled, single ascending-
and repeat-dose Phase 1 study of PTG-300, the company's injectable
hepcidin mimetic peptide, in normal healthy volunteers.
The results, which included the successful completion of the
study extension to include two additional dose cohorts, confirm the
previously announced preliminary data showing the ability of
PTG-300 to achieve a dose-related and sustained effect on iron
distribution based on reduction in serum iron and transferrin
saturation. PTG-300 treatment was well-tolerated, with no serious
adverse events or dose-limiting toxicities reported. The most
common adverse events were localized and transient injection site
reactions in some subjects.
"We are very pleased with the positive results from this initial
safety, pharmacokinetic and pharmacodynamic (PD) study of PTG-300
in normal healthy volunteers," said Richard
S. Shames, M.D., Protagonist Therapeutics Chief Medical
Officer. "These results clearly demonstrate PD-based clinical
proof-of-concept (POC) for PTG-300. They also set the stage for
further discussions with the Health Authorities in early 2018,
regarding our Investigational New Drug (IND) application and
ex-U.S. clinical trial applications to initiate global trials of
PTG-300 in patients with beta-thalassemia and myelodysplastic
syndrome (MDS)."
About Hepcidin and Anemia/Iron Overload Diseases
PTG-300, an injectable hepcidin mimetic, is currently in
clinical development for the potential treatment of
beta-thalassemia and MDS, rare diseases characterized by chronic
anemia and iron overload. PTG-300 therapy may also be beneficial in
other diseases such as hereditary hemochromatosis, polycythemia
vera, siderophilic infections, and liver fibrosis which provide
opportunities for further development. Hepcidin is a peptide
hormone that is the main regulatory hormone governing iron
absorption, recycling and utilization by the body. Iron plays an
essential role in various body functions, especially blood
formation, but too much iron is toxic and causes organ damage over
time. Abnormally low hepcidin levels, caused by genetic mutations
or secondary pathology, can result in the body absorbing and
storing more iron than is needed, leading to iron overload.
About Protagonist Therapeutics
Protagonist Therapeutics is a clinical-stage biopharmaceutical
company with a proprietary technology platform which is utilized to
discover and develop novel peptide-based drugs to address
significant unmet medical needs. Its primary focus is on developing
potential first-in-class, oral targeted therapy-based peptide drugs
that work by blocking biological pathways that are currently
targeted by marketed injectable antibody drugs. Protagonist's
initial lead peptide product candidates, PTG-100 and PTG-200, are
based on this approach, and the company believes these candidates
have the potential to transform the existing treatment paradigm for
inflammatory bowel disease (IBD), consisting primarily of
ulcerative colitis and Crohn's disease.
PTG-100, a potential first-in-class oral peptide alpha-4-beta-7
integrin antagonist, is currently in a global Phase 2B clinical trial for the treatment of
moderate-to-severe ulcerative colitis. PTG-200, a potential
first-in-class oral Interleukin-23 receptor antagonist in
development for the treatment of IBD, initially Crohn's disease,
has entered a Phase 1 clinical trial. Protagonist has entered into
a worldwide agreement with Janssen Biotech, Inc. to co-develop and
commercialize PTG-200 for all indications, including IBD.
In addition to PTG-100 and PTG-200, the company is developing an
injectable hepcidin mimetic PTG-300 for the potential treatment of
anemia and iron overload disorders, including rare diseases such as
beta-thalassemia and MDS. PTG-300 has now completed a Phase 1
clinical trial.
Protagonist is headquartered in Newark, California with its pre-clinical and
clinical staff in California, and
discovery operations both in California and in Brisbane, Queensland, Australia. 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 for our programs, our
collaborations, the initiation and availability of results of our
clinical trials, research and development and capital resources. 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 history of net operating losses, our reliance on third parties
and uncertainty regarding our ability to achieve profitability, 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, 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. We discuss many of these risks in greater
detail under the heading "Risk Factors" contained in our quarterly
report on Form 10-Q for the quarter ended September 30, 2017 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.
View original content with
multimedia:http://www.prnewswire.com/news-releases/protagonist-therapeutics-announces-final-phase-1-study-results-with-novel-hepcidin-mimetic-ptg-300-300571268.html
SOURCE Protagonist Therapeutics, Inc.