NEWARK, Calif., Dec. 2, 2021 /PRNewswire/ -- Protagonist
Therapeutics (Nasdaq: PTGX) ("Protagonist" or "the Company")
today announced the selection of PN-235 (JNJ-77242113) as the final
candidate for all clinical studies in multiple indications based on
intervention of the Interleukin-23 (IL-23) pathway, under the
Company's collaboration with Janssen Biotech, Inc. (Janssen). In
addition to the previously announced Phase 2 clinical study of
PN-235 in psoriasis, new Phase 2 clinical studies of PN-235 in
inflammatory bowel diseases (IBD) are expected to commence in late
2022. Further development of PN-232 (JNJ-7510586) will be
discontinued in favor of PN-235 based on its superior potency, and
overall pharmacokinetic and pharmacodynamic profile.
"We are delighted to see PN-235 emerge as the clear focal point
going forward, after over four-plus years of a highly productive
and ongoing collaboration with Janssen," said Dinesh V. Patel, PhD, President and CEO of
Protagonist. "We look forward to exploring the full potential
of a highly differentiated, oral targeted therapy like PN-235,
thereby potentially addressing persistent unmet needs of patients
with immune-mediated diseases like psoriasis and IBD."
Protagonist will earn a $25
million milestone in connection with the initiation of the
first Phase 2 study of PN-235 in psoriasis in early 2022.
Protagonist is also eligible for a $10
million milestone in connection with the start of the second
indication-based Phase 2 study. Protagonist is eligible for up to
approximately $900 million in
development-related milestone payments, in addition to the
$87.5M in milestones already earned.
Under the terms of the collaboration, Janssen will conduct all
future clinical studies, including these anticipated Phase 2
studies, and will be solely financially responsible for any such
studies.
About Protagonist
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 currently 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 recently
completed Phase 2a study for hereditary hemochromatosis. The
Company plans to initiate a single, global Phase 3 randomized,
placebo-controlled trial evaluating the efficacy and safety of a
once weekly, subcutaneously self-administered dose of
rusfertide.
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 in development include
PN-235, a second-generation oral interleukin-23 receptor antagonist
candidate. Under the collaboration with Janssen, PN-235 is expected
to advance into Phase 2 studies in psoriasis and new Phase 2
clinical studies in inflammatory bowel diseases.
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 collaboration with
Janssen, the timing of Janssen's PN-235 trials and the potential
benefits of PN-235. 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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