Protagonist Announces Icotrokinra Phase 2b ANTHEM-UC Trial Data to be Presented at the United European Gastroenterology Week Berlin 2025

Rhea-AI Summary

Protagonist Therapeutics (NASDAQ:PTGX) announced an upcoming presentation of Phase 2b ANTHEM-UC trial data for icotrokinra in ulcerative colitis at the United European Gastroenterology Week (UEGW) 2025 in Berlin. The presentation will focus on the 12-week results of this randomized, double-blind, placebo-controlled study.

Dr. Maria Abreu from Cedars-Sinai Medical Center will present findings on this targeted oral peptide that selectively blocks IL-23 receptor activation in moderately to severely active ulcerative colitis. The presentation is scheduled for October 7, 2025, at 3:06 PM CET in the Helsinki Room during the Advanced Therapies in Ulcerative Colitis session.

NEWARK, CALIFORNIA / ACCESS Newswire / September 15, 2025 / Protagonist Therapeutics, Inc. ("Protagonist" or the "Company") announced that data from the Phase 2b ANTHEM-UC study with icotrokinra in ulcerative colitis will be the focus of a brief oral presentation at the United European Gastroenterology Week 2025 being held in Berlin, Germany from October 4^th through June 7^th, 2025.

Presentation Details:

Presenting author: Maria Abreu, MD (Cedars-Sinai Medical Center)

Title: Icotrokinra, a Targeted Oral Peptide that Selectively Blocks Il-23 Receptor Activation, in Moderately to Severely Active Ulcerative Colitis: Week 12 Results from the Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Treat-Through, Dose-Ranging Anthem-UC Trial

Session Name: Advanced Therapies in Ulcerative Colitis
Session Date: Tuesday, October 7, 2025
Presentation Time: 3:06 PM - 3:18 PM CET
Location: Helsinki Room

UEGW abstracts are now available on the UEGW website and the presentation itself will provide a complete data update.

About Protagonist

Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company. Two novel peptides derived from Protagonist's proprietary discovery platform are currently in advanced Phase 3 clinical development, with New Drug Application (NDA) for icotrokinra submitted to the FDA in July and in the NDA submission for rusfertide expected by end of 2025. Icotrokinra (formerly, JNJ-2113), a first-in-class investigational targeted oral peptide that selectively blocks the Interleukin-23 receptor ("IL-23R") is licensed to J&J Innovative Medicines ("JNJ"), formerly Janssen Biotech, Inc. Following icotrokinra's joint discovery by Protagonist and JNJ scientists pursuant to the companies' IL-23R collaboration, Protagonist was primarily responsible for development of icotrokinra through Phase 1, with JNJ assuming responsibility for development in Phase 2 and beyond. Rusfertide, a mimetic of the natural hormone hepcidin, is currently in Phase 3 development for the rare blood disorder polycythemia vera (PV). Rusfertide is being co-developed and will be co-commercialized with Takeda Pharmaceuticals pursuant to a worldwide collaboration and license agreement entered in 2024 under which the Company remains primarily responsible for development through NDA filing. The Company also has a number of pre-clinical stage drug discovery programs addressing clinically and commercially validated targets, including IL-17 oral peptide antagonist PN-881, obesity triple agonist peptide PN-477, and the oral hepcidin program.

More information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at https://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 the potential benefits of icotrokinra, and expectations regarding the icotrokinra development program. 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 with Janssen and Takeda, 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.

Investor Relations Contact

Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com

Media Contact

Virginia Amann, Founder/CEO
+1 833 500 0061 ext 1
ENTENTE Network of Companies
virginiaamann@ententeinc.com

SOURCE: Protagonist Therapeutics

View the original press release on ACCESS Newswire

FAQ

When will Protagonist Therapeutics (PTGX) present the ANTHEM-UC trial data at UEGW 2025?

Protagonist will present the data on Tuesday, October 7, 2025, from 3:06 PM to 3:18 PM CET in the Helsinki Room.

What is icotrokinra and what is being studied in the PTGX ANTHEM-UC trial?

Icotrokinra is a targeted oral peptide that selectively blocks IL-23 receptor activation, being studied in patients with moderately to severely active ulcerative colitis.

Who will present the Protagonist Therapeutics Phase 2b trial results at UEGW 2025?

Dr. Maria Abreu from Cedars-Sinai Medical Center will present the Phase 2b ANTHEM-UC trial results.

What type of study is the PTGX ANTHEM-UC trial?

It is a Phase 2b, randomized, double-blind, placebo-controlled, treat-through, dose-ranging trial studying icotrokinra in ulcerative colitis.

Where can investors find the PTGX ANTHEM-UC trial abstract?

The abstracts are currently available on the UEGW website, with complete data to be presented during the conference.