NEWARK, Calif., May 24, 2017 /PRNewswire/ -- Protagonist
Therapeutics, Inc. (Nasdaq: PTGX) today announced the receipt of a
Phase 2 Small Business Innovation Research (SBIR) Grant from the
National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) of the National Institutes of Health (NIH). This
award, Number 2R44DK104445-02, provides up to $1.34 million over two years to support research
aimed at developing biomarkers that define IL-23 receptor (IL-23R)
target engagement by oral peptide antagonists and the effects of
that engagement on downstream signaling. Such biomarkers can be
used for demonstrating early pharmacodynamics clinical
proof-of-concept and estimating effective dose range for the
treatment of inflammatory bowel diseases (IBD) with anti-IL-23R
agents, including Protagonist's oral peptide drug candidate,
PTG-200. The company expects to initiate human clinical testing of
PTG-200 in the second half of 2017.
Protagonist's research has shown that oral treatment with
PTG-200 significantly improves disease outcomes in an animal model
of colitis through specific inhibition of the IL-23R signaling
pathway. Moreover, treatment-related responses from biomarkers
profiled in this research, including biomarkers identified and
tracked in blood, feces, and/or colon biopsies, provide a
potentially valuable way of assessing mechanism-specific and
disease-related parameters, as well as demonstrating clinical
effect in human trials.
"We are very pleased to receive this grant, which recognizes the
considerable benefit that could be provided by biomarkers of IL-23R
signaling activity in IBD," said Dinesh
Patel, Ph.D., Protagonist Therapeutics' President and Chief
Executive Officer. "The SBIR program at NIH plays a vital role in
helping companies develop new technology and products that serve
important U.S. health care needs, and we sincerely thank them for
their support."
"This award will help us further develop accessible and
measurable biomarkers that are useful for understanding the ability
of our oral peptide agents to target and modulate the activity of
IL-23 receptors in the gastrointestinal tract, for demonstrating
early pharmacodynamic activity in human trials, and for choosing
the appropriate dose ranges of such agents for clinical development
in IBD," said David Y. Liu, Ph.D.,
Protagonist's Chief Scientific Officer.
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 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 in pre-clinical development and is expected to
enter Phase 1 clinical studies in the second quarter of 2017.
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.
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, the
timing of the initiation of our clinical trials, the possibility of
obtaining orphan drug designation for our product candidates and
our potential receipt of funding under the SBIR grant. In some
cases, you can identify these statements by forward-looking words
such as "anticipate," "believe," "may," "will," "continue,"
"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 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 March 31, 2017, filed with the Securities and
Exchange Commission on May 10, 2017.
Forward-looking statements are not guarantees of future
performance, and our actual results of operations, financial
condition and liquidity, and the development of the industry in
which we operate, may differ materially from the forward-looking
statements contained in this press release. 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.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/protagonist-therapeutics-receives-134-million-sbir-funding-for-development-of-biomarkers-of-il-23-receptor-antagonist-activity-300463036.html
SOURCE Protagonist Therapeutics, Inc.