Protagonist Therapeutics announced two additional oral peptide IL-23 receptor antagonist candidates from its collaboration agreement with Janssen Biotech 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.
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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.