NEWARK, Calif., Sept. 6, 2018 /PRNewswire/ -- Protagonist
Therapeutics, Inc. (Nasdaq: PTGX) today announced the receipt of a
Phase 2 Small Business Innovation Research (SBIR) Grant from the
National Heart, Lung and Blood Institute of the National Institutes
of Health. This award, Number R44HL132702, provides up to
$1.45 million over two years to
support research aimed at developing the Company's novel hepcidin
mimetic clinical drug for the potential treatment of chronic anemia
and iron overload in rare blood disorders, including
beta-thalassemia.
"This grant recognizes the potential benefit of our hepcidin
mimetic PTG-300 in the treatment of blood disorders associated with
iron metabolism," said David Liu,
Ph.D., Protagonist Therapeutics' Head of R&D and Chief
Scientific Officer. "We expect that the results of the research
will lead to methods and biomarkers that could be useful in guiding
clinical trial design and evaluating clinical results as we explore
multiple opportunities to develop PTG-300 in multiple indications.
We look forward to the initiation of a global Phase 2 study of
PTG-300 in beta-thalassemia in the fourth quarter of the year."
The objective of the SBIR-funded research is to develop methods
for characterizing in vivo target engagement, including
pharmacokinetic and pharmacodynamic methods to characterize PTG-300
interactions, effects on pathway and disease biomarkers, and
effects in pre-clinical disease models.
The content of this press release is solely the views of its
authors and does not represent the official views of the National
Institutes of Health.
About Protagonist Therapeutics, Inc.
Protagonist Therapeutics is a clinical stage biopharmaceutical
company that utilizes a proprietary technology platform to discover
and develop novel peptide-based drugs to transform existing
treatment paradigms for patients with significant unmet medical
needs. PTG-100 is an oral alpha-4-beta-7 integrin antagonist
peptide that is under development for potential treatment of
inflammatory bowel diseases. PTG-200 is an oral peptide
interleukin-23 receptor antagonist in development for the treatment
of Crohn's disease. The company has entered into a worldwide
license and collaboration agreement with Janssen Biotech for the
clinical development of PTG-200. Protagonist is also developing an
injectable hepcidin mimetic, PTG-300, for the potential treatment
of anemia and iron overload related to rare blood diseases with an
initial focus on beta-thalassemia. The company has completed a
Phase 1 clinical trial of PTG-300, which established
pharmacodynamic-based clinical proof-of-concept in normal healthy
volunteers. The U.S. Food and Drug Administration has granted
Orphan Drug Designation to PTG-300 for beta-thalassemia for which a
global Phase 2 trial is to be initiated in the fourth quarter of
2018. Treatment of patients with myelodysplastic syndromes,
hereditary hemochromatosis and polycythemia vera represent
additional opportunities for future development of PTG-300.
Protagonist is headquartered in Newark, California, with pre-clinical and
clinical staff in California and
discovery operations in both California and Brisbane, Queensland, Australia. For further
information, please visit http://www.protagonist-inc.com.
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
research and development plans, the utility of our intellectual
property, and the adequacy of our capital resources. In some cases,
you can identify these statements by forward-looking words such as
"anticipate," "believe," "may," "will," "would," or "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 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 June 30, 2018
as filed with the Securities and Exchange Commission. Any
forward-looking statements that we make in this press release speak
only as of the date of this press release. We assume no obligation
to update our forward-looking statements, whether as a result of
new information, future events or otherwise, after the date of this
press release.
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SOURCE Protagonist Therapeutics, Inc.