NEWARK, Calif., Dec. 16, 2020 /PRNewswire/ -- Protagonist
Therapeutics, Inc. (Nasdaq:PTGX) today announced that the first
subject has been dosed in a Phase 1 study of PN-235 (also
referenced as JNJ-77242113), an oral interleukin-23 receptor
(IL-23R) antagonist peptide. The study is designed to determine the
safety, tolerability and pharmacokinetics of PN-235 in
approximately 100 healthy volunteers. PN-235 is being developed as
part of a portfolio strategy of discovering and developing oral
IL-23 receptor antagonists as part of an ongoing collaboration with
Janssen Biotech, Inc.
"PN-235 is the first second-generation, oral, IL-23 receptor
antagonist candidate as part of our research collaboration with
Janssen to enter clinical development and was discovered through
the application of the Protagonist peptide technology platform,"
commented Dinesh V. Patel, Ph.D.,
Protagonist President and Chief Executive Officer. "We are
extremely pleased with the success of our collaborative efforts,
and see significant potential for multiple indications with orally
delivered therapeutics that act by targeting the well-validated
IL-23 pathway. We expect Phase 1 results in 2021."
The PN-235 Phase 1 study will be conducted in three parts: a
single ascending dose, a multiple ascending dose, and a randomized,
crossover solid dose comparison part. The primary endpoint is
safety as measured by number and severity of adverse events.
Secondary outcomes include pharmacokinetics measurements of peak
concentration (Cmax) of and area under the curve (AUC). Information
on the study is available at
https://clinicaltrials.gov/ct2/show/NCT04621630.
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 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. In addition to PTG-200, two oral peptide
interleukin-23 receptor antagonist candidates are in development
and have been selected for advancement into clinical studies.
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 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 our product
candidates to improve standards of care, our ability to fund
operations into future periods, 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, 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 September
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.