Protagonist Therapeutics Announces New Development Candidate PN-10943 for the Treatment of Inflammatory Bowel Disease
"Because of the strength of our peptide technology platform, we have had the flexibility to discover and evaluate PN-10943 as a backup peptide with improved drug characteristics over PTG-100," commented
"Development of PN-10943 will enable us to incorporate knowledge and experience acquired from our prior studies with PTG-100, which has provided early evidence of safety and preliminary efficacy with an oral, gut-restricted alpha-4-beta-7 integrin antagonist peptide approach in patients with ulcerative colitis. Having achieved this clinical proof-of-concept with PTG-100, we are now able to execute on this validated approach with the more potent peptide PN-10943. In addition, replacing PTG-100 in our pipeline provides greater financial flexibility by now extending our cash runway to fund operations by an additional six months to the end of 2020. This projection assumes the receipt of a potential
The planned PN-10943 Phase 1 study will be a randomized, double-blind, placebo-controlled, dose escalation (100, 300, 1000 and 1400 mg) trial in 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 the administration of PN-10943 over 14 consecutive days in escalating dose cohorts. Primary endpoints for the study are safety and tolerability of PN-10943. Secondary endpoints include evaluation of PK and PD parameters of %RO.
A corporate update including a brief summary of preclinical data of PN-10943 in comparison to PTG-100 and key milestones for all development assets in the pipeline (PN-10943, PTG-200 and PTG-300) will be provided on a conference call hosted by Protagonist. Additional details from preclinical studies of PN-10943 will be presented at a future medical conference.
Conference Call and Webcast Information
Protagonist executives will host a conference call and webcast with slides available at
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, the timing of the initiation and availability of results of our clinical trials and our potential milestone payment receipt and cash runway. 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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