Protagonist Therapeutics (PTGX) Reports Positive Phase 1 Results for JNJ-2113

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.

Highlights of the data presented on JNJ-2113 include the following:

• JNJ-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 data demonstrated pre-clinical proof-of-concept in skin inflammation and colitis disease models, highlighting JNJ-2113's potential for therapeutic utility in both psoriasis and inflammatory bowel diseases implicated in the IL-23 pathway. We look forward to the presentation of the Phase 2b FRONTIER 1 study data in adults with moderate-to-severe plaque psoriasis later this year."

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