NEWARK, Calif., Nov. 6, 2019 /PRNewswire/ -- Protagonist
Therapeutics, Inc. (Nasdaq:PTGX) today announced that the first
patient has been dosed in a Phase 2 study of PTG-200 (also
referenced as JNJ-67864238) in patients with moderate to severe
Crohn's disease. PTG-200 is an oral, gut-restricted, interleukin-23
receptor (IL-23R) antagonist for the potential treatment of
inflammatory bowel diseases. Protagonist Therapeutics and Janssen
Research & Development are jointly conducting the development
of PTG-200 through completion of Phase 2 clinical proof of concept
in the treatment of Crohn's disease.
"We are pleased to be progressing PTG-200 in collaboration with
Janssen in a Phase 2 study in patients with Crohn's disease,"
commented Dinesh V. Patel, Ph.D.,
Protagonist President and Chief Executive Officer. "We believe this
gut-restricted oral therapy may offer meaningful advantages over
injectable therapeutics currently available for Crohn's disease and
other inflammatory bowel diseases. We look forward to results from
this study in 2021."
The global, randomized, double blind, placebo-controlled, Phase
2 study is evaluating the efficacy of oral administration of
PTG-200 in 90 patients with moderate to severe Crohn's disease. The
study will assess the effect of twice-daily dosing of PTG-200 on
change from baseline in Crohn's Disease Activity Index (CDAI) score
at week 12 as the primary endpoint. The study will also assess
change from baseline in simple endoscopic score for Crohn's disease
(SES-CD), rates of clinical response and remission, endoscopic
response and remission, and patient-reported outcome (PRO)-2
remission. Additional information on the PTG-200 Crohn's disease
study is available at
https://clinicaltrials.gov/ct2/show/NCT04102111.
According to the terms of the development agreement between
Protagonist and Janssen Research & Development, Janssen will be
responsible for further development and commercialization
activities beyond Phase 2 development. Protagonist is eligible to
receive over $1 billion in research,
development, regulatory and sales milestone payments related to
PTG-200 and related compounds and 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 trial in
healthy volunteers demonstrated that PTG-200 was well tolerated,
with pharmacokinetic measures consistent with the gut-restricted
design of PTG-200.
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 Research & Development 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 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 new debt facility, intentions or current
expectations concerning, among other things, future financing
activities, achievement of clinical development milestones and the
availability of results of our clinical trials. In some cases, you
can identify these statements by forward-looking words such as
"expect," "will," "intend," "potential," or the negative or plural
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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 achieve certain clinical development
milestones and other specified conditions and our ability to
develop and commercialize 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
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after the date of this press release.
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SOURCE Protagonist Therapeutics, Inc.