Protagonist Therapeutics Initiates Phase 3 Clinical Program for Psoriasis Treatment and Phase 2b Study for Ulcerative Colitis

Protagonist Therapeutics, a biopharmaceutical company, has announced the initiation of its Phase 3 clinical program for the treatment of moderate to severe plaque psoriasis in adults. The program, called ICONIC, will consist of two studies starting in November. Additionally, the company will begin the ANTHEM-UC Phase 2b study this month, focusing on adults with moderately to severely active ulcerative colitis.

The clinical development program for JNJ-2113, an oral peptide designed to block the IL-23 receptor, reflects Protagonist’s commitment to providing an effective oral treatment option for patients. The company’s partnership with Janssen Biotech, a subsidiary of Johnson & Johnson, has been instrumental in advancing the drug candidate.

Dinesh V. Patel, President and CEO of Protagonist, expressed confidence in the potential of JNJ-2113 and the strength of the partnership between Protagonist and Janssen. He highlighted the innovative power of Protagonist’s peptide technology platform and the commitment to improving the lives of patients.

As part of the collaboration agreement, Protagonist will be eligible to receive milestone payments totaling $60 million in the fourth quarter. This includes a $50 million milestone payment upon dosing of the third patient in the ICONIC Phase 3 program and a $10 million milestone payment upon dosing of the third patient in the ANTHEM-UC Phase 2b study. The company also remains eligible for additional milestone and royalty payments.

The Phase 3 studies in the ICONIC program will build upon the positive results from the previously completed FRONTIER 1 study, utilizing the once-daily, immediate-release formulation. Further Phase 3 studies will be initiated in the first quarter of 2024 as part of the broader psoriasis ICONIC clinical program.

Protagonist’s commitment to advancing JNJ-2113 demonstrates its dedication to developing innovative treatments for psoriasis and expanding into other potential indications, such as inflammatory bowel disease. With the support of Janssen Biotech, the company aims to address the unmet needs of patients and provide them with effective oral treatment options.

For more information about Protagonist Therapeutics, its pipeline drug candidates, and ongoing clinical studies, visit the company’s website at protagonist-inc.com.