NEWARK, Calif., Nov. 9, 2017 /PRNewswire/ -- Protagonist
Therapeutics, Inc. (Nasdaq: PTGX) today announced the initiation of
dosing in a Phase I healthy volunteer study of PTG-200, a potential
first-in-class, gastrointestinal-restricted, oral peptide
interleukin (IL)-23 receptor antagonist. PTG-200 works by blocking
the IL-23 pathway, a mechanism that has been targeted by currently
marketed injectable antibody treatments for inflammatory bowel
disease (IBD) and other autoimmune conditions.
"We are very pleased to initiate this first-in-human trial of
PTG-200," said Richard S. Shames,
M.D., Protagonist Therapeutics Chief Medical Officer. "There
remains a significant need for novel improved therapies in
inflammatory bowel disease. An oral treatment could offer
significant advantages, including improved patient convenience and
compliance, and the potential for improved safety and
tolerability."
"The initiation of the first human study of PTG-200 is an
important step forward in our collaboration with Janssen around
this asset," said Dinesh Patel,
Ph.D., Protagonist President and Chief Executive Officer.
"Protagonist started the year with one drug candidate in clinical
development, and we are now ending 2017 with three assets in
clinical development, all of which emerged from our innovative
peptide technology platform."
The Phase 1 study, which is being conducted in Australia, is a randomized, double-blind,
placebo-controlled, single and multiple dose-escalation trial in
approximately eighty healthy volunteers. The study will be
conducted in three parts: single-ascending doses of PTG-200;
multiple ascending doses; and a single dose cross-over, comparing
tablet to capsule formulations of PTG-200. Primary endpoints for
the study are safety and tolerability of PTG-200. Secondary
endpoints include the identification of the maximally tolerated
dose and evaluation of pharmacokinetic and pharmacodynamic
parameters.
Protagonist is developing PTG-200 in collaboration with Janssen
Biotech, Inc. (Janssen), which has licensed the worldwide rights to
PTG-200 for all indications including IBD.
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, is currently being studied in 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 in iron overload disorders, including rare diseases such as
beta-thalassemia and MDS. PTG-300 is currently being studied in 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 "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 reliance on third parties, our ability to
develop and commercialize our product candidates, 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, and our ability to effectively conduct
clinical trials 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.
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SOURCE Protagonist Therapeutics, Inc.