JNJ-2113 (formerly PN-235) met the
study's primary endpoint, with a statistically significantly higher
proportion of adult patients with moderate-to-severe plaque
psoriasis achieving PASI-75 in all treatment groups at Week 16
compared to placebo
Treatment was well tolerated, with no
meaningful difference in frequency of adverse events across
treatment groups
NEWARK,
Calif., March 7, 2023 /PRNewswire/ -- Protagonist
Therapeutics, Inc. (Nasdaq: PTGX) ("Protagonist" or "the Company"),
today announced positive topline results from its collaboration
with Janssen Biotech, Inc., one of the Janssen Pharmaceutical
Companies of Johnson & Johnson
(Janssen), in the FRONTIER 1 Phase 2b clinical trial evaluating the oral
Interleukin-23 receptor (IL-23R) antagonist peptide JNJ-2113 in
patients with moderate-to-severe plaque psoriasis.
Data from the 255-patient study showed that JNJ-2113 achieved
the study's primary efficacy endpoint, with a statistically
significant greater proportion of patients who received JNJ-2113
achieving PASI-75 (a 75% improvement in skin lesions as measured by
the Psoriasis Area and Severity Index) responses compared to
placebo at Week 16 in all five treatment groups. A clear dose
response was observed across an eight-fold dose range. Treatment
was well tolerated, with no meaningful difference in frequency of
adverse events across treatment groups versus placebo. Data will be
presented from various pre-clinical and clinical studies on
JNJ-2113 at medical conferences beginning in the second quarter of
2023.
"We are thrilled to be at this transformative junction, with
JNJ-2113 being the first- and only-in-class oral IL-23 receptor
antagonist as a potential oral targeted therapy for plaque
psoriasis, further underscoring the strength of our innovative
peptide technology platform. A full measure of JNJ-2113 should be
evident when the FRONTIER 1 Phase 2b
data are shared at an upcoming medical conference. It is our
expectation that JNJ-2113 will progress into a Phase 3
registrational study in plaque psoriasis on the strength of these
data. We are excited about JNJ-2113's potential prospects across
the spectrum of additional IL-23 mediated diseases," said
Dinesh V. Patel, Ph.D., President
and Chief Executive Officer at Protagonist.
Dr. Patel continued, "We see this as a watershed moment for
Protagonist, the industry, and patients by successfully targeting a
systemic immunomodulatory IL-23 monoclonal antibody pathway through
an oral peptide antagonist. We are humbled to be part of this
significant scientific breakthrough."
JNJ-2113 Clinical Trials
The FRONTIER 1 Phase 2b trial
(NCT05223868) was designed to assess the efficacy and safety
of JNJ-2113 in patients with moderate-to-severe plaque psoriasis.
It is a randomized, multicenter, double-blind, placebo-controlled
study that evaluated three once-daily dosages and two twice-daily
dosages of JNJ-2113 taken orally. The primary endpoint of the
study is the proportion of patients achieving PASI-75 at 16
weeks.
Beyond the recently completed Phase 2b FRONTIER 1 study and
a Phase 1 trial (NCT05062200) in healthy Japanese and Chinese
participants, JNJ-2113 is currently being studied in multiple
trials, also led by Janssen. FRONTIER 2 (NCT05364554) is a
long-term extension study of JNJ-2113 in adults with moderate to
severe plaque psoriasis; the SUMMIT Phase 2a trial (NCT05357755) is
testing a delayed release JNJ-2113 tablet versus placebo in adults
with moderate to severe plaque psoriasis; and a Phase 1 trial
(NCT05703841) of an immediate release formulation of JNJ-2113 in
healthy Chinese adult participants is currently recruiting.
Janssen License and Collaboration Agreement
JNJ-2113 (formerly known as PN-235) was discovered and is
being developed pursuant to the license and collaboration agreement
between Protagonist and Janssen Biotech, Inc., one of the Janssen
Pharmaceutical Companies of Johnson & Johnson. Protagonist
completed a Phase 1 study of JNJ-2113 in healthy volunteers in
October of 2021 and Janssen retains exclusive, worldwide rights to
develop in Phase 2 and beyond, and to commercialize compounds
derived from the research conducted pursuant to the agreement
against a broad range of indications.
About Protagonist
Protagonist Therapeutics is a biopharmaceutical company with
peptide-based new chemical entities rusfertide and JNJ-2113
(formerly PN-235) in advanced stages of clinical development, both
derived from the Company's proprietary technology platform.
Rusfertide, a mimetic of the natural hormone hepcidin, is the
Company's lead drug candidate, currently in a global Phase 3 stage
of development. The Phase 3 VERIFY and Phase 2 REVIVE studies of
rusfertide in polycythemia vera are ongoing. Protagonist retains
all worldwide development and commercialization rights to
rusfertide.
Advancement of JNJ-2113 into a Phase 3 study and meeting the
primary endpoint in that study would qualify Protagonist for
milestone payments of $50 million and
$115 million, respectively. In total,
Protagonist remains eligible for up to $855
million in various milestone payments and tiered royalties
based on worldwide net drug sales.
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, our expectations regarding
Janssen's development of JNJ-2113 (formerly PN-235), our receipt of
milestones and other payments under our license and collaboration
agreement with Janssen, and the commercial potential of JNJ-2113.
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 Biotech,
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.