Protagonist Announces Achievement of $50M Milestone Event After Third Patient is Dosed in Phase 3 Study of JNJ-2113 in Moderate-to-Severe Psoriasis

NEWARK, CA / ACCESSWIRE / November 1, 2023 / Protagonist Therapeutics, Inc. ("Protagonist" or the "Company") today announced the achievement of a $50 million milestone event under its license and collaboration agreement with Janssen Biotech, Inc., a Johnson & Johnson company ("Janssen"). The milestone was earned when the third patient was dosed in the ICONIC TOTAL Phase 3 clinical study of JNJ-2113 in patients with moderate-to-severe psoriasis.

"We are very pleased to see the ICONIC Phase 3 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 3 psoriasis studies planned for JNJ-2113 as part of the broader ICONIC clinical program, and patient enrollment in the ANTHEM UC Phase 2b 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 2b randomized control trial to evaluate the safety and effectiveness of JNJ-2113 compared with placebo in participants with moderate-to-severe active ulcerative colitis.

More information about each of the active JNJ-2113 trials can be found at the following links on clinicaltrials.gov: ICONIC-LEAD, ICONIC-TOTAL, and ANTHEM-UC; and a prior Protagonist press release.

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 2 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 2b 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.