Data point to the potential of JNJ-2113 as a first-in-class
drug candidate in multiple IL-23 driven-diseases
NEWARK,
Calif., May 12, 2023 /PRNewswire/
-- Protagonist Therapeutics (Nasdaq: PTGX) ("Protagonist"
or "the Company") reported data from its collaboration with Janssen
Biotech, Inc., one of the Janssen Pharmaceutical Companies of
Johnson & Johnson (Janssen), on
Phase 1 and preclinical studies of JNJ-2113 (formerly PN-235),
presented by Janssen and co-authored with Protagonist, as an oral
presentation at the International Societies for Investigative
Dermatology (ISID) 2023 meeting in Tokyo,
Japan. The presentation, "First-in-class oral peptide
systemically targeting the IL-23 pathway," is available online at
isid2023.org for registered users.
Highlights of the data presented on JNJ-2113 include the
following:
- JNJ-2113 is a macrocyclic peptide that binds to the IL-23
receptor with single digit picomolar affinity and demonstrated
potent, selective inhibition of IL-23 signaling in human T
cells.
- Although peptides typically have low oral bioavailability, the
high potency of JNJ-2113, along with its oral stability, indicated
potential for systemic activity beyond the gastrointestinal tract
in rat models of inflammation and colitis.
-
- In a rat trinitrobenzene sulfonic acid (TNBS)-induced colitis
model, efficacy was observed as measured by attenuation of weight
loss and colon inflammation with oral doses of JNJ-2113 as low as
0.3 mg/kg/day.
- In an IL-23-induced rat skin inflammation model, orally dosed
JNJ-2113 achieved inhibition of inflammation equivalent to an IL-23
antibody, along with reduction of IL-17 and IL-22 cytokines.
- Oral treatment with JNJ-2113 provided selective systemic IL-23
pathway inhibition in pre-clinical models that successfully
translated to systemic pharmacodynamics activity in healthy human
volunteers, indicating potential for JNJ-2113 as a first-in-class
oral therapy targeting IL-23-mediated diseases.
"JNJ-2113 is a potential first-in-class drug candidate in
multiple aspects, such as with respect to its biological target,
the IL-23 receptor; its oral mode of drug delivery; and its
chemical modality as a peptide, representing a major breakthrough
in the field of innovative oral peptide-based therapeutics," said
Dinesh V. Patel, Ph.D., President
and CEO of Protagonist. "These data demonstrated pre-clinical
proof-of-concept in skin inflammation and colitis disease models,
highlighting JNJ-2113's potential for therapeutic utility in both
psoriasis and inflammatory bowel diseases implicated in the IL-23
pathway. We look forward to the presentation of the Phase
2b FRONTIER 1 study data in adults
with moderate-to-severe plaque psoriasis later this year."
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 REVIVE study is now complete, with an
open-label extension underway. The global Phase 3 VERIFY study of
rusfertide in polycythemia vera is ongoing. Protagonist retains all
worldwide development and commercialization rights to
rusfertide.
Positive topline results from the FRONTIER 1 study of JNJ-2113
in moderate-to-severe plaque psoriasis became available in
March 2023, with further details to
be shared at medical meetings starting in the second quarter of
2023. 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.
More information on Protagonist, its pipeline drug candidates
and clinical studies can be found on the Company's website at
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, our expectations regarding the
potential benefits and therapeutic utility 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, delays or difficulties
in enrolling or completing clinical studies, the potential that
results from clinical or non-clinical studies indicate our
compounds or product candidates are unsafe or ineffective,
dependence on third parties to conduct clinical studies and
manufacture our products, 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, impact of natural disasters and the impact of
the ongoing military conflict in Ukraine and Russia on any future studies, 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.