NEWARK, CA, USA I May 24, 2021 I Protagonist Therapeutics, Inc. (Nasdaq:PTGX) today announced that the first human subject has been dosed in a Phase 1 study of PN-232, a novel oral interleukin-23 receptor (IL-23R) antagonist peptide. This study is designed to determine the safety, tolerability, and pharmacokinetics of PN-232 in healthy volunteers. Recruitment for the study is ongoing.

“PN-232 is a second-generation, oral, IL-23 receptor antagonist candidate currently being developed in collaboration with Janssen Research & Development, LLC,” said Dinesh V. Patel, Ph.D., President and Chief Executive Officer at Protagonist. “Today’s announcement marks another step forward in our joint efforts to discover and develop novel oral treatment regimens for diseases that are moderated by intervention on the IL-23 pathway. Our joint efforts have now led to three different oral IL-23 antagonists: PTG-200, PN-235, and PN-232.” 

This Phase 1 study is designed to determine the safety, tolerability, and pharmacokinetics of PN-232 in healthy volunteers. It is a first-in-human study for PN-232 that will be conducted in three parts. Part 1 is a single ascending dose study, Part 2 is multiple ascending dose study, and Part 3 is crossover solid dose comparison and effect-of-food study. More complete information on the study is available at https://clinicaltrials.gov/ct2/show/NCT04819620.

Protagonist and Janssen Biotech, Inc., have a research, co-development and commercialization agreement for IL-23 receptor targeted therapeutics with applications in various disease areas. According to the agreement, Janssen will be responsible for development and commercialization activities of compound candidates beyond Phase 2. 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 Protagonist Therapeutics
Protagonist Therapeutics is a biopharmaceutical company with multiple peptide-based investigational new chemical entities in different stages of development, all derived from the Company’s proprietary technology platform.

Protagonist-developed compounds currently include rusfertide (PTG-300), an investigational, injectable hepcidin mimetic in a Phase 2 proof-of-concept clinical trial for polycythemia vera, and a separate Phase 2 clinical study for hereditary hemochromatosis. Based on the feedback provided by the FDA and EU regulatory authorities, the Company plans to initiate a single, global Phase 3 randomized, placebo-controlled trial evaluating the efficacy and safety of a once weekly, subcutaneously self-administered dose of rusfertide. Additionally, PN-943 is an investigational orally delivered, gut-restricted alpha-4-beta-7 integrin specific antagonist peptide currently in a Phase 2 study for the potential treatment of inflammatory bowel disease, with ulcerative colitis as the initial targeted indication.

The Company has a worldwide license and collaboration agreement with Janssen Biotech, Inc., for the development of oral peptide IL-23 receptor antagonists. Compounds included in this agreement are PTG-200, PN-235 and PN-232. PTG-200 is an orally delivered, gut-restricted, interleukin-23 receptor specific antagonist peptide in a Phase 2 clinical trial for Crohn’s disease. PN-235 and PN-232, both second-generation oral interleukin-23 receptor antagonist candidates, are in Phase 1 studies.

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

SOURCE: Protagonist Therapeutics