NEWARK, Calif., Sept. 17, 2021 /PRNewswire/ -- Protagonist
Therapeutics, Inc. (Nasdaq: PTGX) ("Protagonist" or "the Company")
today announced the receipt of a verbal communication from the U.S.
Food and Drug Administration (FDA) that Protagonist's clinical
studies for rusfertide, an investigational product candidate
currently in development, have been placed on a clinical hold.
The clinical hold follows Protagonist's notification to the FDA
of a recent non-clinical finding in a 26-week rasH2 transgenic
mouse model study. The rasH2 model is designed to detect signals
related to tumorigenicity, and benign and malignant subcutaneous
skin tumors were observed in this study.
The Company is working with the FDA and will be prepared to make
all appropriate updates to clinical study documents and determine
the next steps in consultation with the FDA. In particular, we will
provide additional clinical safety reports, update the investigator
brochures and patient informed consent forms, and make necessary
modifications to study protocols. Dosing of patients in all ongoing
clinical trials with rusfertide will be put on hold, and study
investigators have been contacted to facilitate patient
"Patient safety is our absolute top priority," said Dinesh Patel, President and Chief Executive
Officer of Protagonist. "We are fully committed to working closely
with the FDA in understanding and evaluating potential clinical
risks and determining next steps for the development of
About Protagonist Therapeutics
Protagonist Therapeutics is a biopharmaceutical company
with multiple peptide-based investigational new chemical entities
in different stages of development, all derived from the Company's
proprietary technology platform. Protagonist's pipeline includes
rusfertide (PTG-300), an investigational, injectable hepcidin
mimetic in a Phase 2 proof-of-concept clinical trial for
polycythemia vera (PV), a Phase 2 study in PV subjects with high
hematocrit levels, and a Phase 2 study for hereditary
The Company is also evaluating an orally delivered,
gut-restricted alpha-4-beta-7 integrin specific antagonist peptide
(PN-943) currently in a Phase 2 study in adults with moderate to
severe active ulcerative colitis (UC). The Company is targeting
ulcerative colitis 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. Compounds included in this agreement
are PTG-200, PN-235 and PN-232. PTG-200 is an orally delivered
interleukin-23 receptor specific antagonist peptide in a Phase 2
clinical trial for Crohn's disease. PN-235 and PN-232, both
second-generation oral interleukin-23 receptor antagonist
candidates, are currently in Phase 1 studies.
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 Company's clinical development
program for rusfertide. 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
agreements, 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 most recently
filed periodic reports on Form 10-K and Form 10-Q 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.