NEWARK, Calif., Oct. 29, 2020 /PRNewswire/ -- 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.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions or current expectations concerning, among other things, the potential of compounds selected for clinical development pursuant to our collaboration with Janssen Biotech, Inc., the potential activity and attributes of compounds developed pursuant to the collaboration, and our expectations regarding the timing of the initiation of clinical trials. In some cases, you can identify these statements by forward-looking words such as "anticipate," "believe," "may," "will," "expect," or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreement with Janssen, the impact of the current COVID-19 pandemic on our discovery and development efforts, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates. Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading "Risk Factors" contained in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, filed with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release.
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