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
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,
'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
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
About Protagonist
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
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