Protagonist Therapeutics Initiates Phase 1 Trial of Oral, Gut-Restricted, Alpha-4-Beta-7 Integrin Antagonist PN-10943
"This study builds on our previous clinical studies that investigated an oral, gut-restricted approach for the treatment of inflammatory bowel disease," commented
The Phase 1 study is a randomized, double-blind, placebo-controlled, dose escalation (100, 300, 1000 and 1400 mg) trial in up to 80 normal healthy volunteers. The first part of the study consists of single ascending doses of PN-10943. The second part of the study will involve once daily administration of PN-10943 over 14 consecutive days in escalating dose cohorts. Primary endpoints for the study are safety and tolerability. Secondary endpoints include evaluation of pharmacokinetic properties and pharmacodynamic parameters of blood receptor occupancy.
Protagonist is headquartered in
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 for our programs, including PN-10943, and the timing of the initiation and availability of results of our 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, 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. We discuss many of these risks in greater detail under the heading "Risk Factors" contained in our quarterly report on Form 10-Q for the three months ended
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