JNJ-2113 Advances in Clinical Development Programs for Plaque Psoriasis, Ulcerative Colitis

Protagonist Therapeutics, Inc., has announced¹ that JNJ-2113 (formerly PN-235) will be eligible to advance into multiple clinical development programs for indications such as plaque psoriasis and ulcerative colitis.

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In the fourth quarter of this year, Protagonist will be eligible to receive approximately $60 million in milestone payments for clinical development programs from Janssen Biotech, Inc. Janssen has been a partner of Protagonist in the development of the novel, first, and only oral IL-23 receptor antagonist peptide for moderate to severe plaque psoriasis.²

In July, Janssen announced2 positive top-line results for the drug in its phase 2b FRONTIER 1 clinical trial evaluating JNJ-2113's efficacy in patients with moderate to severe plaque psoriasis. JNJ-2113 met all established primary and secondary endpoints, including Psoriasis Area and Severity Index markers and was generally well-tolerated in patients.

Read the Dermatology Times reporting on the FRONTIER 1 trial here (March 2023) and here (July 2023).

In November, 2 phase 3 trials that will be part of the clinical development program, ICONIC-LEAD and ICONIC-TOTAL, will commence for adults with moderate to severe plaque psoriasis. ICONIC-TOTAL will evaluate JNJ-2113's efficacy in plaque psoriasis affecting special areas of the body, including the scalp, palms of the hands or soles of the feet, or genital areas.

ANTHEM-UC, a phase 2b trial of the drug in an ulcerative colitis indication, will also commence during this quarter. In the first quarter of 2024, additional studies making up the broader psoriasis ICONIC program will also commence.

A $50 million milestone payment will be made upon dosing of the third patient in the ICONIC trials, with a $10 million milestone payment to be made at the same milestone in the ANTHEM trial.

"The robust and expanding clinical development program for JNJ-2113, the first and only targeted oral peptide designed to block the IL-23 receptor, reflects the tremendous level of commitment and confidence for this drug candidate, and its potential to have a positive impact in the lives of patients who can benefit from an oral treatment option," said Dinesh V. Patel, PhD, in a press release.¹ Patel is the president and CEO of Protagonist.

"The success of the IL-23 receptor antagonist peptide program from de novo discovery through initiation of multiple Phase 3 studies in psoriasis and expansion into inflammatory bowel disease and other potential indications reflects the innovative power of Protagonist's peptide technology platform and the strength of a synergistic partnership between Protagonist and Janssen," he said.

References

1. Protagonist Therapeutics Inc. Protagonist announces advancement of JNJ-2113 across multiple indications. ACCESSWIRE News Room. October 9, 2023. Accessed October 9, 2023. https://www.accesswire.com/791174/protagonist-announces-advancement-of-jnj-2113-across-multiple-indications.
2. Janssen announces positive topline results for JNJ-2113 - a novel, first and only oral IL-23 receptor antagonist peptide in development for moderate-to-severe plaque psoriasis. Content Lab U.S. July 4, 2023. Accessed October 9, 2023. https://www.jnj.com/janssen%20announces%20positive%20topline%20results%20for%20jnj-2113%E2%80%94a%20novel,%20first%20and%20only%20oral%20il-23%20receptor%20antagonist%20peptide%20in%20development%20for%20moderate-to-severe%20plaque%20psoriasis.