NEWARK, Calif., Jan. 7, 2020 /PRNewswire/ -- Protagonist
Therapeutics, Inc. (Nasdaq: PTGX) today announced the achievement
of a research milestone under its worldwide license and research
collaboration agreement with Janssen Biotech, Inc. ("Janssen"), for
co-development activities with affiliate Janssen Research &
Development, LLC, and commercialization of oral, gut-restricted
IL-23 receptor antagonist PTG-200 (JNJ-67864238) and second
generation peptides for all indications including inflammatory
bowel disease (IBD). The successful nomination of a
second-generation development candidate triggers a $5 million milestone payment to Protagonist.
"We are highly encouraged by the progress with Janssen in the
successful application of our technology platform for the discovery
and development of gut-restricted IL-23 receptor antagonist
peptides as oral targeted therapy for IBD," commented Dinesh V. Patel, Ph.D., Protagonist
President and Chief Executive Officer. "Our first product
candidate PTG-200 remains on track for Phase 2 results in Crohn's
disease expected in 2021. This recent milestone demonstrates both
the utility of the platform and our commitment to the overall
strategic objective of bringing new oral medicines to patients with
IBD."
According to the terms of the agreement between Protagonist and
Janssen, Protagonist is eligible to receive potential payments over
the life of the collaboration. The payments are in the form of
research, development, regulatory and sales milestones linked to
development of PTG-200 and related compounds. Protagonist also has
an option to co-detail PTG-200 and related compounds in the U.S.
market.
About PTG-200 (JNJ-67864238)
PTG-200 is an oral peptide interleukin-23 receptor (IL-23R)
antagonist being co-developed with Janssen for the treatment of
inflammatory bowel disease and is initially in development for the
treatment of patients with Crohn's disease. PTG-200 is designed to
offer choices to patients in addition to injectable antibody
therapeutics that target the IL-23 pathway, including the potential
for improved safety and tolerability and better compliance compared
to therapeutics administered by injection. Results from a Phase 1
randomized, double blind, placebo-controlled, single- and
multiple-dose escalation study in healthy volunteers demonstrated
that PTG-200 was well tolerated, with pharmacokinetic measures
consistent with its design as a compound restricted to the
gastrointestinal system. Protagonist and Janssen are jointly
conducting a global, randomized, double blind, Phase 2
proof-of-concept study of PTG-200 in 90 patients with moderate to
severe Crohn's disease. Additional information on the PTG-200
Crohn's disease study is available at
https://clinicaltrials.gov/ct2/show/NCT04102111.
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 drugs to transform existing
treatment paradigms for patients with significant unmet medical
needs. PTG-300 is an injectable hepcidin mimetic in development for
the potential treatment of iron overload anemia and related rare
blood diseases including beta-thalassemia, polycythemia vera and
hereditary hemochromatosis. PTG-200 is an oral, gut-restricted
interleukin-23 receptor specific antagonist peptide in Phase 2
clinical development for the potential treatment of inflammatory
bowel disease, with Crohn's disease as the initial indication. The
Company has a worldwide license and collaboration agreement with
Janssen Biotech, Inc., for the clinical development of PTG-200.
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 a Phase 2 ulcerative
colitis study expected to commence in the second quarter 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 development and potential of
PTG-200 as a possible treatment for inflammatory bowel disease, the
timing and results of clinical trials for PTG-200, the results of
our collaboration agreement with Janssen and the timing of any
payments from the collaboration agreement with Janssen. In some
cases, you can identify these statements by forward-looking words
such as "plan," "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, and
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 quarterly period ended
September 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.