NEWARK, Calif., May 25, 2017 /PRNewswire/ -- Protagonist
Therapeutics, Inc. (Nasdaq: PTGX) today announced that the company has initiated a Phase 1 clinical study of PTG-300 in normal
healthy volunteers. PTG-300 is an injectable hepcidin mimetic peptide discovered using the company's proprietary technology
platform, and it is being developed as a potential treatment for patients with chronic iron overload in rare diseases such as
beta-thalassemia.
Hepcidin is a principal regulator of iron homeostasis in humans, and low levels of hepcidin may be associated with iron
overload-related diseases such as thalassemia, myelodysplastic syndrome, and hereditary hemochromatosis. Iron overload can damage
target organs and tissues including the bone marrow, liver, and heart leading to increased risks of anemia, liver disease, heart
attack, heart failure, diabetes, and premature death. Beta-thalassemia is a rare, inherited blood disorder characterized by an
underproduction of hemoglobin that affects nearly 15,000 people in the United States with
greater prevalence in the rest of the world.
"We are pleased with the pre-clinical data for PTG-300, which has showed efficacy in a beta-thalassemia mouse model and
demonstrated a dose-dependent reduction in serum iron levels across three different healthy animal species," stated Dinesh V. Patel, Ph.D., President and Chief Executive Officer, Protagonist Therapeutics. "The initiation of
this study marks the progression of Protagonist's second drug candidate into clinical development, and we remain on track to have
three different assets in our clinical pipeline by the end of 2017."
The Phase 1 single ascending dose study will evaluate the safety, tolerability, and pharmacokinetics of PTG-300 in normal
healthy volunteers. In addition, the effect of PTG-300 on baseline serum iron levels will be analyzed to evaluate
pharmacodynamics-based clinical proof-of-concept. The company expects to report results from this trial in the fourth quarter of
2017.
About Protagonist Therapeutics
Protagonist Therapeutics is a clinical-stage biopharmaceutical company with a proprietary technology platform which is
utilized to discover and develop novel peptide-based drugs to address significant unmet medical needs. Its primary focus is on
developing potential first-in-class oral targeted therapy-based peptide drugs that work by blocking biological pathways that are
currently targeted by marketed injectable antibody drugs. Protagonist's initial lead peptide product candidates, PTG-100 and
PTG-200, are based on this approach, and the company believes these candidates have the potential to transform the existing
treatment paradigm for inflammatory bowel disease (IBD), chronic gastrointestinal diseases consisting primarily of ulcerative
colitis and Crohn's disease.
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 moderate-to-severe ulcerative colitis. PTG-200, a potential first-in-class oral Interleukin-23 receptor
antagonist for potential treatment of IBD, initially Crohn's disease, is currently in pre-clinical development and is expected to
enter Phase 1 clinical studies in the second half of 2017.
In addition to PTG-100 and PTG-200, the company is developing an injectable hepcidin mimetic PTG-300 as a potential orphan
drug for the treatment of rare diseases such as beta-thalassemia. PTG-300 is currently being studied in a Phase 1 clinical
trial.
Protagonist is headquartered in Newark, California with its pre-clinical and clinical staff in California, and
discovery operations both in California and in Brisbane, Queensland, Australia. For further information, please visit http://www.protagonist-inc.com.
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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, the timing of initiation and availability of results of our
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SOURCE Protagonist Therapeutics, Inc.