NEWARK, Calif., Oct. 29, 2020 /PRNewswire/ -- Protagonist
Therapeutics, Inc. (NASDAQ:PTGX) today announced that two
additional oral peptide IL-23 receptor antagonist candidates from
its collaboration agreement with Janssen Biotech, Inc., have been
selected for advancement into clinical development. The two new
candidates, PN-235 (JNJ-77242113) and PN-232 (JNJ-75105186), are
being developed as part of a portfolio strategy of discovering and
developing oral IL-23 receptor antagonists. The initial oral
candidate in the collaboration agreement, PTG-200 (JNJ-67864238),
is currently in a Phase 2 proof-of-concept study in patients with
moderate to severe Crohn's disease.
"Nominating two additional oral, IL-23 receptor antagonists for
clinical development from the ongoing research collaboration with
Janssen demonstrates our continued success, commitment to the IL-23
pathway franchise, and the versatility of our peptide engineering
platform," commented Dinesh V.
Patel, Ph.D., Protagonist President and Chief Executive
Officer. "The IL-23 pathway is a validated therapeutic mechanism,
but orally delivered therapeutics for this class have not been
available. The advancement of three different oral co-development
candidates provides us with several strategic options for
development in multiple indications. We look forward to the
initiation of a Phase 1 study of PN-235 in the fourth quarter of
2020."
Protagonist Therapeutics and Janssen are jointly conducting the
development of PTG-200 through completion of Phase 2 clinical proof
of concept in the treatment of Crohn's disease. Protagonist and
Janssen have established a co-development and commercialization
agreement for IL-23 receptor targeted therapeutics with
applications in various disease areas. According to the terms of
the agreement, Janssen will be responsible for further development
and commercialization activities of candidates beyond Phase 2
development. Protagonist is eligible to receive research,
development, regulatory and sales milestone payments and has an
option to co-detail products 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
provide 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.
PTG-200 is in Phase 2 development for the treatment of Crohn's
disease. Information on the 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 therapeutics to address significant
unmet medical needs and transform existing treatment paradigms for
patients. PTG-300 is an injectable hepcidin mimetic in development
for the treatment of polycythemia vera and other blood disorders.
PTG-200 is an orally delivered, gut-restricted, interleukin-23
receptor specific antagonist peptide in development for the
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
development of oral peptide IL-23 receptor antagonists. PN-943 is
an orally delivered, gut-restricted alpha-4-beta-7 integrin
specific antagonist peptide in development for the treatment of
inflammatory bowel disease, with ulcerative colitis as the initial
targeted indication.
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 compounds selected
for clinical development pursuant to our collaboration with Janssen
Biotech, Inc., the potential activity and attributes of compounds
developed pursuant to the collaboration, and our expectations
regarding the timing of the initiation of clinical trials. 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 ability to develop and
commercialize our product candidates, our ability to earn milestone
payments under our collaboration agreement with Janssen, the impact
of the current COVID-19 pandemic on our discovery and development
efforts, 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. 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 quarter ended June 30, 2020, 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.