Protagonist Therapeutics Announces Advancement of Oral IL-23 Receptor Antagonists Program in Collaboration with Janssen

NEWARK, CA, USA I October 29, 2020 I Protagonist Therapeutics, Inc. (NASDAQ:PTGX) today announced that two additional oral peptide IL-23 receptor antagonist candidates from its collaboration agreement with Janssen Biotech, Inc., have been selected for advancement into clinical development. The two new candidates, PN-235 (JNJ-77242113) and PN-232 (JNJ-75105186), are being developed as part of a portfolio strategy of discovering and developing oral IL-23 receptor antagonists. The initial oral candidate in the collaboration agreement, PTG-200 (JNJ-67864238), is currently in a Phase 2 proof-of-concept study in patients with moderate to severe Crohn's disease.

"Nominating two additional oral, IL-23 receptor antagonists for clinical development from the ongoing research collaboration with Janssen demonstrates our continued success, commitment to the IL-23 pathway franchise, and the versatility of our peptide engineering platform," commented Dinesh V. Patel, Ph.D., Protagonist President and Chief Executive Officer. "The IL-23 pathway is a validated therapeutic mechanism, but orally delivered therapeutics for this class have not been available. The advancement of three different oral co-development candidates provides us with several strategic options for development in multiple indications. We look forward to the initiation of a Phase 1 study of PN-235 in the fourth quarter of 2020."

Protagonist Therapeutics and Janssen are jointly conducting the development of PTG-200 through completion of Phase 2 clinical proof of concept in the treatment of Crohn's disease. Protagonist and Janssen have established a co-development and commercialization agreement for IL-23 receptor targeted therapeutics with applications in various disease areas. According to the terms of the agreement, Janssen will be responsible for further development and commercialization activities of candidates beyond Phase 2 development. Protagonist is eligible to receive research, development, regulatory and sales milestone payments and has an option to co-detail products in the U.S. market.

About PTG-200 (JNJ-67864238)

PTG-200 is an oral peptide interleukin-23 receptor (IL-23R) antagonist being co-developed with Janssen for the treatment of inflammatory bowel disease and is initially in development for the treatment of patients with Crohn's disease. PTG-200 is designed to provide the potential for improved safety and tolerability and better compliance compared to therapeutics administered by injection. Results from a Phase 1 randomized, double blind, placebo-controlled, single- and multiple-dose escalation trial in healthy volunteers demonstrated that PTG-200 was well tolerated, with pharmacokinetic measures consistent with the gut-restricted design of PTG-200.

PTG-200 is in Phase 2 development for the treatment of Crohn's disease. Information on the study is available at https://clinicaltrials.gov/ct2/show/NCT04102111.

About Protagonist Therapeutics, Inc.

Protagonist Therapeutics is a clinical stage biopharmaceutical company that utilizes a proprietary technology platform to discover and develop novel peptide-based therapeutics to address significant unmet medical needs and transform existing treatment paradigms for patients. PTG-300 is an injectable hepcidin mimetic in development for the treatment of polycythemia vera and other blood disorders. PTG-200 is an orally delivered, gut-restricted, interleukin-23 receptor specific antagonist peptide in development for the treatment of inflammatory bowel disease, with Crohn's disease as the initial indication. The Company has a worldwide license and collaboration agreement with Janssen Biotech, Inc., for the development of oral peptide IL-23 receptor antagonists. PN-943 is an orally delivered, gut-restricted alpha-4-beta-7 integrin specific antagonist peptide in development for the treatment of inflammatory bowel disease, with ulcerative colitis as the initial targeted indication.

Protagonist is headquartered in Newark, California. For further information, please visit http://www.protagonist-inc.com.

SOURCE: Protagonist Therapeutics

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