Topline results also show investigational targeted oral
peptide icotrokinra achieved clinical remission rates up
to 30.2% at Week 12 and a favorable safety profile in
Phase 2b ANTHEM-UC study
Clinical response and remission rates continued to improve
through Week 28, building on strong data recently reported for the
plaque psoriasis Phase 3 program
Icotrokinra demonstrates potential to offer therapeutic
benefit and tolerability with a once daily oral treatment
SPRING
HOUSE, Pa., March 10,
2025 /PRNewswire/ -- Johnson & Johnson
(NYSE: JNJ) today announced positive topline results from
ANTHEM-UC, a Phase 2b study of
icotrokinra (JNJ-2113), the first investigational targeted oral
peptide that selectively blocks the IL-23 receptor, in adults with
moderately to severely active ulcerative colitis (UC). The study
met its primary endpoint of clinical responsea in all
icotrokinra dose groups evaluated and demonstrated clinically
meaningful differences versus placebo in key secondary endpoints of
clinical remissionb, symptomatic remission and
endoscopic improvement at Week 12.
In the ANTHEM-UC study (n=252), three doses of once daily
icotrokinra were tested with all meeting the primary endpoint of
clinical response at Week 12. A response rate of 63.5% for patients
treated with the highest dose of icotrokinra was achieved at Week
12 versus 27% for placebo (p<0.001). Further, 30.2% of patients
treated with the highest dose of icotrokinra demonstrated clinical
remission at Week 12 versus 11.1% of patients who received placebo
(p<0.001). Remission and response rates continued to improve
through Week 28.1
Icotrokinra was well tolerated with proportions of participants
reporting one or more adverse events (AEs) being similar between
the icotrokinra dose groups and the placebo group.1
"These impressive findings show the potential of icotrokinra to
transform the treatment paradigm for people living with ulcerative
colitis by offering a distinctive combination of therapeutic
benefit, tolerability, and convenience with a once-daily oral
treatment," said Esi Lamousé-Smith, M.D., Ph.D., Vice President,
Gastroenterology Disease Area Lead, Immunology, Johnson &
Johnson. "With over a quarter century of innovation in inflammatory
bowel disease, coupled with our deep expertise in the IL-23
pathway, we are excited about these results and the groundbreaking
potential of icotrokinra in the treatment of immune-mediated
diseases."
Comprehensive results from the ANTHEM-UC study are being
prepared for presentation at upcoming medical congresses.
Editor's notes:
a. Clinical response is defined as decrease from baseline in the
modified Mayo score by greater than or equal to (>=) 30 percent
(%) and >=2 points, with either a >=1-point decrease from
baseline in the rectal bleeding subscore or a rectal bleeding
subscore of 0 or 1.
b. Clinical remission is defined as a Mayo stool
frequency subscore of 0 or 1 and not increased from induction
baseline, a Mayo rectal bleeding subscore of 0, and a Mayo
endoscopy subscore of 0 or 1 with no friability present on the
endoscopy.
About ANTHEM-UC
ANTHEM-UC (NCT06049017) is a Phase 2b multicenter, randomized, placebo-controlled,
dose-ranging study to evaluate the efficacy and safety of
icotrokinra (JNJ-77242113, JNJ-2113) in patients with moderately to
severely active ulcerative colitis who had an inadequate response
or intolerance to conventional therapy (e.g., thiopurines or
corticosteroids), prior biologics (TNF antagonists or vedolizumab)
and/or ozanimod or approved JAK inhibitors. The study is
evaluating three once-daily dosages of icotrokinra taken
orally.2
About Ulcerative Colitis
Ulcerative colitis (UC) is a chronic disease of the large
intestine, also known as the colon, in which the lining of the
colon becomes inflamed and develops tiny open sores, or ulcers,
that produce pus and mucus. It is the result of the immune system's
overactive response. Symptoms vary but may typically include
loose and more urgent bowel movements, rectal bleeding or bloody
stool, persistent diarrhea, abdominal pain, loss of appetite,
weight loss, and fatigue.3
About Icotrokinra (JNJ-77242113, JNJ-2113)
Investigational icotrokinra is the first targeted oral peptide
designed to selectively block the IL-23 receptor,4 which
underpins the inflammatory response in moderate-to-severe plaque
psoriasis, ulcerative colitis and offers potential in other
IL-23-mediated diseases.5,6 Icotrokinra binds to
the IL-23 receptor with single-digit picomolar affinity and
demonstrated potent, selective inhibition of IL-23 signalling in
human T cells.7 The license and collaboration agreement
established between Protagonist Therapeutics, Inc. and Janssen
Biotech, Inc., a Johnson & Johnson company, in 2017 enabled the
companies to work together to discover and develop next-generation
compounds that ultimately led to
icotrokinra.8 Icotrokinra was jointly discovered
and is being developed pursuant to the license and collaboration
agreement between Protagonist and Johnson &
Johnson. Johnson & Johnson retains exclusive
worldwide rights to develop icotrokinra in Phase 2 clinical trials
and beyond, and to commercialize compounds derived from the
research conducted pursuant to the agreement against a broad range
of indications.9,10,11
Icotrokinra is being studied in the pivotal Phase 3 ICONIC
clinical development program in moderate-to-severe plaque psoriasis
and active psoriatic arthritis and the Phase 2b ANTHEM-UC study in moderately to severely
active ulcerative colitis.
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our
strength in healthcare innovation empowers us to build a world
where complex diseases are prevented, treated, and cured, where
treatments are smarter and less invasive, and solutions are
personal. Through our expertise in Innovative Medicine and MedTech,
we are uniquely positioned to innovate across the full spectrum of
healthcare solutions today to deliver the breakthroughs of tomorrow
and profoundly impact health for humanity.
Learn more at https://www.jnj.com/ or at
www.innovativemedicine.jnj.com.
Follow us at @JNJInnovMed.
Janssen Research & Development, LLC and Janssen Biotech,
Inc. are Johnson & Johnson companies.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as
defined in the Private Securities Litigation Reform Act of 1995
regarding icotrokinra (JNJ-2113). The reader is cautioned not to
rely on these forward-looking statements. These statements are
based on current expectations of future events. If underlying
assumptions prove inaccurate or known or unknown risks or
uncertainties materialize, actual results could vary materially
from the expectations and projections of Janssen Research &
Development, LLC, Janssen Biotech, Inc. and/or Johnson &
Johnson. Risks and uncertainties include, but are not limited to:
challenges and uncertainties inherent in product research and
development, including the uncertainty of clinical success and of
obtaining regulatory approvals; uncertainty of commercial success;
manufacturing difficulties and delays; competition, including
technological advances, new products and patents attained by
competitors; challenges to patents; product efficacy or safety
concerns resulting in product recalls or regulatory action; changes
in behavior and spending patterns of purchasers of health care
products and services; changes to applicable laws and regulations,
including global health care reforms; and trends toward health care
cost containment. A further list and descriptions of these risks,
uncertainties and other factors can be found in Johnson &
Johnson's most recent Annual Report on Form 10-K, including in the
sections captioned "Cautionary Note Regarding Forward-Looking
Statements" and "Item 1A. Risk Factors," and in Johnson &
Johnson's subsequent Quarterly Reports on Form 10-Q and other
filings with the Securities and Exchange Commission. Copies of
these filings are available online at www.sec.gov, www.jnj.com or
on request from Johnson & Johnson. None of Janssen Research
& Development, LLC, Janssen Biotech, Inc. nor Johnson &
Johnson undertakes to update any forward-looking statement as a
result of new information or future events or
developments.
1Data on file.
2Clinicaltrials.gov. A Study of JNJ-77242113 in
Participants With Moderately to Severely Active Ulcerative Colitis
(ANTHEM-UC). Identifier NCT06049017.
https://clinicaltrials.gov/study/NCT06049017?term=ANTHEM-UC&rank=1.
Accessed February 2025.
3Crohn's & Colitis Foundation. What is ulcerative
colitis? Available at:
https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis.
Accessed April 2024.
4Bissonnette R, et al. Data presentation. A phase 2,
randomized, placebo-controlled, dose-ranging study of oral
JNJ-77242113 for the treatment of moderate-to-severe plaque
psoriasis: FRONTIER 1. Presented at WCD 2023, July 3-8.
5Razawy W, et al. The role of IL‐23 receptor
signaling in inflammation‐mediated erosive autoimmune arthritis and
bone remodeling. Eur J Immunol. 2018 Feb; 48(2):
220–229.
6Tang C, et al. Interleukin-23: as a drug target for
autoimmune inflammatory diseases. Immunology. 2012 Feb;
135(2): 112–124.
7Pinter A, et al. Data Presentation. JNJ-77242113
Treatment Induces a Strong Systemic Pharmacodynamic Response Versus
Placebo in Serum Samples of Patients with Plaque Psoriasis: Results
from the Phase 2, FRONTIER 1 Study. Presented at EADV 2023,
October 11-14.
8Johnson & Johnson. Press release. Janssen enters
into worldwide exclusive license and collaboration agreement with
Protagonist Therapeutics, Inc. for the oral Interlukin-23 receptor
antagonist drug candidate for the treatment of Inflammatory Bowel
Disease. Available at:
https://www.jnj.com/media-center/press-releases/janssen-enters-into-worldwide-exclusive-license-and-collaboration-agreement-with-protagonist-therapeutics-inc-for-the-oral-interlukin-23-receptor-antagonist-drug-candidate-for-the-treatment-of-inflammatory-bowel-disease.
Accessed November 2024.
9Protagonist Therapeutics. Press release. Protagonist
Therapeutics announces amendment of agreement with Janssen Biotech
for the continued development and commercialization of IL-23
antagonists. Available at:
https://www.prnewswire.com/news-releases/protagonist-therapeutics-announces-amendment-of-agreement-with-janssen-biotech-for-the-continued-development-and-commercialization-of-il-23-antagonists-301343621.html.
Accessed November 2024.
10Protagonist Therapeutics. Press release.
Protagonist Reports positive results from Phase 1 and pre-clinical
studies of oral Interleukin-23 receptor antagonist JNJ-2113.
Available at:
https://www.prnewswire.com/news-releases/protagonist-reports-positive-results-from-phase-1-and-pre-clinical-studies-of-oral-interleukin-23-receptor-antagonist-jnj-2113-301823039.html.
Accessed November 2024.
11Protagonist Therapeutics. Press release.
Protagonist Therapeutics announces positive topline results for
Phase 2b FRONTIER 1 clinical trial of
oral IL-23 receptor antagonist JNJ-2113 (PN-235) in psoriasis.
Available at:
https://www.prnewswire.com/news-releases/protagonist-therapeutics-announces-positive-topline-results-for-phase-2b-frontier-1-clinical-trial-of-oral-il-23-receptor-antagonist-jnj-2113-pn-235-in-psoriasis-301764181.html.
Accessed November 2024.
Media contact:
Craig Stoltz
cstoltz@its.jnj.com
Investor contact:
Lauren Johnson
investor-relations@its.jnj.com
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SOURCE Johnson & Johnson
