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The results, which included the successful completion of the study extension to include two additional dose cohorts, confirm the previously announced preliminary data showing the ability of PTG-300 to achieve a dose-related and sustained effect on iron distribution based on reduction in serum iron and transferrin saturation. PTG-300 treatment was well-tolerated, with no serious adverse events or dose-limiting toxicities reported. The most common adverse events were localized and transient injection site reactions in some subjects.
"We are very pleased with the positive results from this initial safety, pharmacokinetic and pharmacodynamic (PD) study of PTG-300 in normal healthy volunteers," said
About Hepcidin and Anemia/Iron Overload Diseases
PTG-300, an injectable hepcidin mimetic, is currently in clinical development for the potential treatment of beta-thalassemia and MDS, rare diseases characterized by chronic anemia and iron overload. PTG-300 therapy may also be beneficial in other diseases such as hereditary hemochromatosis, polycythemia vera, siderophilic infections, and liver fibrosis which provide opportunities for further development. Hepcidin is a peptide hormone that is the main regulatory hormone governing iron absorption, recycling and utilization by the body. Iron plays an essential role in various body functions, especially blood formation, but too much iron is toxic and causes organ damage over time. Abnormally low hepcidin levels, caused by genetic mutations or secondary pathology, can result in the body absorbing and storing more iron than is needed, leading to iron overload.
PTG-100, a potential first-in-class oral peptide alpha-4-beta-7 integrin antagonist, is currently in a global Phase 2B clinical trial for the treatment of moderate-to-severe ulcerative colitis. PTG-200, a potential first-in-class oral Interleukin-23 receptor antagonist in development for the treatment of IBD, initially Crohn's disease, has entered a Phase 1 clinical trial. Protagonist has entered into a worldwide agreement with
In addition to PTG-100 and PTG-200, the company is developing an injectable hepcidin mimetic PTG-300 for the potential treatment of anemia and iron overload disorders, including rare diseases such as beta-thalassemia and MDS. PTG-300 has now completed a Phase 1 clinical trial.
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, our collaborations, the initiation and availability of results of our clinical trials, research and development and capital resources. 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 history of net operating losses, our reliance on third parties and uncertainty regarding our ability to achieve profitability, 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 quarter ended
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