Protagonist announces achievement of $50 million milestone event after third patient is dosed in phase III study of JNJ 2113 in moderate-to-severe psoriasis.
Protagonist Therapeutics, Inc. announced the achievement of a $50 million milestone event under its license and collaboration agreement with Janssen Biotech, Inc., a Johnson & Johnson company
The milestone was earned when the third patient was dosed in the ICONIC TOTAL Phase III clinical study of JNJ 2113 in patients with moderate-to-severe psoriasis.
"We are very pleased to see the ICONIC Phase III program in psoriasis proceeding rapidly and view it as a clear reflection of both the confidence in and the commitment to the continued development of JNJ 2113," said Dinesh V. Patel, Ph.D., President and CEO of Protagonist. "We look forward to the initiation in 2024 of additional Phase III psoriasis studies planned for JNJ 2113 as part of the broader ICONIC clinical program, and patient enrollment in the ANTHEM UC Phase IIb study in ulcerative colitis in the near term. As the first- and only-in-class targeted oral peptide designed to block the IL-23 receptor, JNJ 2113 has the potential, in our view, to serve as a vitally important treatment option for patients with IL-23 pathway mediated diseases."
ANTHEM-UC is a Phase IIb randomized control trial to evaluate the safety and effectiveness of JNJ 2113 compared with placebo in participants with moderate-to-severe active ulcerative colitis.
License and Collaboration Agreement: JNJ 2113 (formerly known as PN 235) 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 healthy volunteers in October of 2021 and Janssen retains exclusive, worldwide rights to develop in Phase II and beyond, and to commercialize compounds derived from the research conducted pursuant to the agreement against a broad range of indications. Protagonist will earn a $10 million milestone payment upon dosing of the third patient in the ANTHEM-UC Phase IIb study, and remains eligible for up to an additional $795 million in further 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.
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