The ICONIC program now includes four Phase 3 studies evaluating JNJ-2113;
Co-primary endpoints for all four studies are PASI-90 and/or IGA 0 or 1
Protagonist eligible to receive $115 million milestone upon achieving the co-primary endpoints in any one of the studies
NEWARK, CA / ACCESSWIRE / November 27, 2023 / Protagonist Therapeutics, Inc. ("Protagonist" or the "Company") today announced two additional Phase 3 studies, ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2, evaluating JNJ-2113 (formerly PN-235) in head-to-head comparisons against deucravacitinib, an oral TYK2 inhibitor, in patients with moderate-to-severe psoriasis. Details regarding ADVANCE 1 are available on clinicaltrials.gov. The ICONIC program now includes four Phase 3 studies: ADVANCE 1, ADVANCE 2 and as previously announced, LEAD and TOTAL. Protagonist is eligible to receive a $115 million milestone payment upon achieving the co-primary endpoints in any one of the studies.
ICONIC-ADVANCE 1 is a Phase 3 trial evaluating the safety and efficacy of JNJ-2113 compared to both placebo and deucravacitinib. The trial's co-primary endpoints are PASI-90 and IGA score of 0 or 1. The trial, which is expected to begin enrolling patients in the first quarter of 2024, is led by the Company's collaboration partner, Janssen Biotech, Inc., a Johnson & Johnson company (Janssen). ICONIC-ADVANCE 2, a similarly designed study, is expected to start enrolling patients later in 2024.
"We are very pleased with the rapid progression of the ICONIC Phase 3 psoriasis program, and in particular with the design of the ICONIC-ADVANCE trials. JNJ-2113 is the only targeted oral peptide in late-stage development that is designed to selectively block the IL-23 receptor, and we believe the ICONIC studies have the potential to establish JNJ-2113 as the preferred oral treatment option for psoriasis patients," said Dinesh V. Patel, Ph.D., President and CEO of Protagonist. "The strength of the FRONTIER 1 Phase 2b data reported in July and the robust designs for the Phase 3 program give us renewed confidence that JNJ-2113 will meet all of our objectives under the terms of our partnership with Janssen."
Details regarding the two previously announced ICONIC Phase 3 psoriasis trials as well as the ANTHEM-UC Phase 2b study evaluating JNJ-2113 in ulcerative colitis, can be found at the following links on clinicaltrials.gov: ICONIC-LEAD, ICONIC-TOTAL and ANTHEM-UC. All of the clinical studies utilize the same once-daily, immediate-release formulation of JNJ-2113 as was used in the successful FRONTIER 1 Phase 2b study.
License and Collaboration Agreement
JNJ-2113 is a first and only targeted oral peptide that is designed to selectively block the IL-23 receptor that was jointly discovered and is being developed pursuant to the license and collaboration agreement between Protagonist and Janssen. Protagonist completed a Phase 1 study of JNJ-2113 in 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 which covers a broad range of indications.
In October 2023, Protagonist earned a $50 million milestone payment related to initiation of the ICONIC Phase 3 program. In addition, Protagonist will earn 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. This includes a $115 million milestone to be paid upon successfully achieving the co-primary endpoints in any of the Phase 3 psoriasis clinical trials, a $50 million milestone upon NDA submission and a $35 million milestone upon NDA approval. The Company is also eligible to earn upward tiering royalties of 6%-10%, with the 10% tier applicable for net sales of greater than $4 billion.
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 and Janssen scientists jointly discovered 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. The randomized portion of the Phase 2 REVIVE study showed positive results and 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.
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 clinical profile of JNJ-2113, our expectations regarding the potential receipt of additional milestone and royalty payments under our collaboration agreement with Janssen. 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.
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LifeSci Advisors
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SOURCE: Protagonist Therapeutics, Inc.