MILPITAS, Calif., Jan. 17, 2017 /PRNewswire/ -- Protagonist
Therapeutics, Inc. (NASDAQ: PTGX) today announced that it has
initiated a global Phase 2b induction study in ulcerative colitis
with PTG-100, an oral peptide that targets alpha4beta7 integrin.
The aim of this randomized, double-blind, placebo-controlled,
adaptive design study is to evaluate the safety/tolerability and
efficacy of PTG-100 in approximately 240 adult ulcerative colitis
patients with moderate to severe active disease.
"We are very pleased to advance our oral, alpha4beta7
integrin-specific antagonist peptide candidate, PTG-100, into this
clinical proof-of-concept and dose optimization study," said
Richard Shames, M.D., Chief Medical
Officer at Protagonist. "We expect to complete the study and report
top-line data in second half of 2018."
Patients will be randomized to one of four dose arms
(150mg/300mg/900mg PTG-100 or placebo) for 12 weeks of once-daily
oral dosing, followed by four weeks of safety follow-up. An interim
futility analysis is expected to be performed in the second half of
2017, and if futility criteria are not met, one or two PTG-100
optimal doses will be selected for continued randomization of the
remaining patients.
The primary efficacy endpoint of the study is clinical remission
(as defined by rectal bleeding, stool frequency, and endoscopic
subscores of the Mayo Score). Secondary endpoints include
additional clinical and safety assessments, as well as
pharmacokinetic, pharmacodynamic and other biomarker measurements
of disease activity.
"PTG-100 is the most advanced asset to have emerged from our
proprietary oral peptide technology platform that enables de
novo discovery and optimization of novel peptides for
protein:protein interaction (PPI) targets," said Dinesh Patel, Ph.D., Protagonist Therapeutics
President and Chief Executive Officer. "Since these PPI targets
have typically been approached by injectable antibody drugs, our
platform offers the distinct advantage of generating oral
therapeutic assets against the same PPI targets utilized by
approved antibody drugs. We look forward to advancing PTG-100 to
clinical proof-of-concept in patients with ulcerative colitis and
applying our technology platform to discovering other novel
peptidic assets to address unmet medical needs."
Approximately 100 sites in the United
States, Canada,
Europe (Western, Central and
Eastern), Asia, Australia, and New
Zealand will participate in the study. For more information
about the study, please
visit https://clinicaltrials.gov/ct2/show/NCT02895100.
About PTG-100
PTG-100 is a potential first-in-class
product candidate that is being developed initially for the
potential treatment of moderate-to-severe active ulcerative
colitis. Alpha4beta7 integrin is considered to be one of the most
gastrointestinal-specific biological targets for inflammatory bowel
disease due to its binding to MAdCAM-1, a cell membrane
protein that resides mostly in the gastrointestinal (GI)
vasculature.
About Protagonist Therapeutics
Protagonist
Therapeutics is a clinical-stage biopharmaceutical company with a
proprietary technology platform focused on discovering and
developing peptide-based new chemical entities to address
significant unmet medical needs. Its primary focus is on developing
first-in-class oral peptide drugs that specifically target the same
biological pathways for which there are marketed injectable
antibody drugs. Compared to injectable antibody drugs,
Protagonist's oral peptides offer preferential drug exposure in the
GI tissue compartment, the potential for improved safety due to
minimal exposure in the blood, improved convenience and compliance,
and potentially an opportunity for the earlier introduction of
targeted therapy for inflammatory bowel disease (IBD).
Protagonist's oral peptide product candidates, PTG-100 and PTG-200,
are based on this approach with the potential to transform the
existing treatment paradigm for IBD, that includes both ulcerative
colitis and Crohn's disease.
PTG-100, a potential first-in-class oral alpha4beta7 integrin
antagonist is being developed initially for moderate-to-severe
active ulcerative colitis. PTG-200, a potential first-in-class oral
Interleukin-23 receptor antagonist is being developed initially for
moderate-to-severe Crohn's disease and is currently in IND-enabling
studies.
The company has a peptide technology platform that enables the
discovery of oral and injectable peptides that can be utilized
against a diverse set of targets and diseases including, but not
confined to the GI. In addition to PTG-100 and PTG-200, the company
is also engaged in the discovery and development of an injectable
hepcidin mimetic, PTG-300, which is currently in IND-enabling
studies. PTG-300 has potential utility for the treatment of iron
overload disorders, such as beta-thalassemia and hereditary
hemochromatosis, each of which may qualify PTG-300 for orphan drug
designation.
Protagonist is headquartered in Milpitas, California with its pre-clinical and
clinical development 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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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, plans, timing and the
availability of results of our clinical trials and the potential
for eventual regulatory approval of our product candidates. In some
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such as "may," "will," "continue," or the negative or plural of
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events to differ materially from those anticipated, including, but
not limited to, our history of net operating losses 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 inability to operate in a
competitive industry and compete successfully against competitors
that have greater resources than we do, our reliance on third
parties, and our ability to obtain and adequately protect
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SOURCE Protagonist Therapeutics, Inc.