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Protagonist Reports Positive Results from Phase 1 and Pre-clinical Studies of Oral Interleukin-23 Receptor Antagonist JNJ-2113

Data point to the potential of JNJ-2113 as a first-in-class drug candidate in multiple IL-23 driven-diseases NEWARK, Calif., May 12, 2023 /PRNewswire/ --

articleProtagonist Therapeutics, Inc.May 12, 20234/company/protagonist-therapeutics-inc/news/protagonist-reports-positive-results-from-phase-1-and-pre-clinical-studies-of-oral
Protagonist Reports Positive Results from Phase 1 and Pre-clinical Studies of Oral Interleukin-23 Receptor Antagonist JNJ-2113

About this update from Protagonist Therapeutics, Inc.

[{"type":"text","content":"Data point to the potential of JNJ-2113 as a first-in-class drug candidate in multiple IL-23 driven-diseases\nNEWARK, Calif., May 12, 2023 /PRNewswire/ -- Protagonist Therapeutics (Nasdaq: PTGX) (\"Protagonist\" or \"the Company\") reported data from its collaboration with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), on Phase 1 and preclinical studies of JNJ-2113 (formerly PN-235), presented by Janssen and co-authored with Protagonist, as an oral presentation at the International Societies for Investigative Dermatology (ISID) 2023 meeting in Tokyo, Japan. The presentation, \"First-in-class oral peptide systemically targeting the IL-23 pathway,\" is available online at isid2023.org for registered users.\n\n \n \n \n \n \n \n\n \nHighlights of the data presented on JNJ-2113 include the following:\nJNJ-2113 is a macrocyclic peptide that binds to the IL-23 receptor with single digit picomolar affinity and demonstrated potent, selective inhibition of IL-23 signaling in human T cells.Although peptides typically have low oral bioavailability, the high potency of JNJ-2113, along with its oral stability, indicated potential for systemic activity beyond the gastrointestinal tract in rat models of inflammation and colitis.In a rat trinitrobenzene sulfonic acid (TNBS)-induced colitis model, efficacy was observed as measured by attenuation of weight loss and colon inflammation with oral doses of JNJ-2113 as low as 0.3 mg/kg/day.In an IL-23-induced rat skin inflammation model, orally dosed JNJ-2113 achieved inhibition of inflammation equivalent to an IL-23 antibody, along with reduction of IL-17 and IL-22 cytokines.Oral treatment with JNJ-2113 provided selective systemic IL-23 pathway inhibition in pre-clinical models that successfully translated to systemic pharmacodynamics activity in healthy human volunteers, indicating potential for JNJ-2113 as a first-in-class oral therapy targeting IL-23-mediated diseases.\"JNJ-2113 is a potential first-in-class drug candidate in multiple aspects, such as with respect to its biological target, the IL-23 receptor; its oral mode of drug delivery; and its chemical modality as a peptide, representing a major breakthrough in the field of innovative oral peptide-based therapeutics,\" said Dinesh V. Patel, Ph.D., President and CEO of Protagonist. \"These da...

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