ICONIC Phase 3 clinical program initiation in adults with moderate to severe plaque psoriasis

ANTHEM Phase 2b initiation in ulcerative colitis

Company is eligible to receive next two milestone payments for a total of $60M

NEWARK, CA / ACCESSWIRE / October 9, 2023 / Protagonist Therapeutics, Inc. ("Protagonist" or the "Company") (NASDAQ:PTGX) today announced that the company will be eligible to receive $60M in milestone payments in the fourth quarter for the advancement of JNJ-2113 into multiple clinical development programs led by Janssen Biotech, Inc., a Johnson & Johnson company (Janssen), the Company's partner in the development of JNJ-2113. The ICONIC clinical development program in adult patients with moderate to severe psoriasis (PsO) is advancing to Phase 3 with two studies starting in November, and the ANTHEM-UC Phase 2b study in adults with moderately to severely active ulcerative colitis (UC) will begin this month.

The three JNJ-2113 studies that are commencing this quarter include:

• ICONIC-LEAD - A randomized controlled Phase 3 trial to evaluate the safety and efficacy of JNJ-2113 compared with placebo in participants with moderate to severe plaque psoriasis, with PASI-90 and IGA score of 0 or 1 as co-primary endpoints;
• ICONIC-TOTAL - A randomized controlled Phase 3 trial to evaluate the efficacy and safety of JNJ-2113 compared with placebo for the treatment of plaque psoriasis in participants with at least moderate severity affecting special areas (scalp, genital, and/or palms of the hands and the soles of the feet) with overall IGA score of 0 or 1 as the primary end point; and
• ANTHEM-UC - A Phase 2b randomized controlled trial to evaluate the safety and effectiveness of JNJ-77242113 compared with placebo in participants with moderately to severely active ulcerative colitis.

Additional Phase 3 studies will be initiated in the first quarter of 2024 as part of the broader psoriasis ICONIC clinical program. All the studies in the ICONIC program will use the once daily, immediate release formulation from the previously completed FRONTIER 1 study.

"The robust and expanding clinical development program for JNJ-2113, the first and only targeted oral peptide designed to block the IL-23 receptor, reflects the tremendous level of commitment and confidence for this drug candidate, and its potential to have a positive impact in the lives of patients who can benefit from an oral treatment option," said Dinesh V. Patel, Ph.D., President and CEO of Protagonist.

"The success of the IL-23 receptor antagonist peptide program from de novo discovery through initiation of multiple Phase 3 studies in psoriasis and expansion into inflammatory bowel disease and other potential indications reflects the innovative power of Protagonist's peptide technology platform and the strength of a synergistic partnership between Protagonist and Janssen."

Protagonist will earn a $50 million milestone payment upon dosing of the third patient in the ICONIC Phase 3 program-whichever study meets that milestone first-and a $10 million milestone payment upon dosing of the third patient in the ANTHEM-UC Phase 2b study, and remains eligible for up to an additional $795 million in other development and sales milestone payments with respect to JNJ-2113. The Company will also earn upward tiering royalties of 6%-10%, with the 10% tier applicable for net sales of greater than $4 billion.

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., a Johnson & Johnson company. Protagonist completed a Phase 1 study of JNJ-2113 in healthy volunteers in October of 2021 and Johnson & Johnson 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 (NCEs) rusfertide and JNJ-2113 (formerly PN-235) in advanced stages of clinical development, both derived from the Company's proprietary technology platform. Protagonist scientists jointly discovered PN-235 (now known as JNJ-2113) as part of Protagonist's Interleukin-23 receptor (IL-23R) collaboration with Janssen and followed it through IND-enabling pre-clinical and Phase 1 studies, with Janssen assuming responsibility for further clinical development. Rusfertide, a mimetic of the natural hormone hepcidin, is the Company's lead drug candidate currently in a global Phase 3 development program for polycythemia vera. The Phase 2 REVIVE study is now complete, with an open-label extension underway. The global Phase 3 VERIFY study is ongoing. Protagonist retains all worldwide development and commercialization rights to rusfertide.

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 the potential benefits of JNJ-2113, our expectations regarding the clinical development of JNJ-2113, our potential receipt of milestone and royalty payments under our collaboration agreement with Janssen, our forecasted cash runway and our expectations regarding enrollment in the REVIVE Phase 3 trial. 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, 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.

Contact

Jami Taylor
Email: j.taylor@ptgx-inc.com

SOURCE: Protagonist Therapeutics, Inc.