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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SOURCE Protagonist Therapeutics, Inc.