The study is designed to determine the safety, tolerability and pharmacokinetics of PN-235 in approximately 100 healthy volunteers. PN-235 is being developed as part of a portfolio strategy of discovering and developing oral IL-23 receptor antagonists as part of an ongoing collaboration with
'PN-235 is the first second-generation, oral, IL-23 receptor antagonist candidate as part of our research collaboration with Janssen to enter clinical development and was discovered through the application of the Protagonist peptide technology platform,' commented
The PN-235 Phase 1 study will be conducted in three parts: a single ascending dose, a multiple ascending dose, and a randomized, crossover solid dose comparison part. The primary endpoint is safety as measured by number and severity of adverse events. Secondary outcomes include pharmacokinetics measurements of peak concentration (Cmax) of and area under the curve (AUC).
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
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 our product candidates to improve standards of care, our ability to fund operations into future periods, 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, 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
Contact:
Tel: +1 646-378-2958
Email: rallan@soleburytrout.com
(C) 2020 Electronic News Publishing, source