NEWARK, Calif., Dec. 13, 2018 /PRNewswire/ -- Protagonist
Therapeutics, Inc. (Nasdaq:PTGX) today announced the initiation of
dosing in the Phase 1 study of PN-10943, an oral, gut-restricted
alpha-4-beta-7 integrin antagonist peptide in development for the
potential treatment of inflammatory bowel disease. The study is
designed to evaluate safety, tolerability, pharmacokinetics and
pharmacodynamic parameters of PN-10943.
"This study builds on our previous clinical studies that
investigated an oral, gut-restricted approach for the treatment of
inflammatory bowel disease," commented Dinesh V. Patel, Ph.D., Protagonist President
and Chief Executive Officer. "PN-10943 has been designed with
superior potency and preclinical properties and applies the same
oral, gut-restricted approach to treatment that has been validated
previously by Protagonist in clinical studies in ulcerative colitis
patients. We expect to report top-line results from this Phase 1
study in the first half of 2019 which will include safety,
pharmacokinetic and pharmacodynamic readouts of target engagement
as measured by blood receptor occupancy. The Phase 1 data will be
used to design a Phase 2a study in ulcerative colitis patients
expected to begin in the second half of 2019."
The Phase 1 study is a randomized, double-blind,
placebo-controlled, dose escalation (100, 300, 1000 and 1400 mg)
trial in up to 80 normal healthy volunteers. The first part of the
study consists of single ascending doses of PN-10943. The second
part of the study will involve once daily administration of
PN-10943 over 14 consecutive days in escalating dose cohorts.
Primary endpoints for the study are safety and tolerability.
Secondary endpoints include evaluation of pharmacokinetic
properties and pharmacodynamic parameters of blood receptor
occupancy.
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-300 is an injectable hepcidin mimetic for the potential
treatment of anemia and iron overload related to rare blood
diseases with an initial focus on beta thalassemia. PTG-200 is an
oral peptide interleukin-23 receptor antagonist in development for
the treatment of Crohn's disease, and it has completed Phase 1
studies in healthy volunteers. The company has entered into a
worldwide license and collaboration agreement with Janssen Biotech
for the clinical development of PTG-200. PN-10943 is an oral,
gut-restricted alpha-4-beta-7 integrin antagonist peptide in
development for the treatment of inflammatory bowel disease.
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,
including PN-10943, and the timing of the initiation and
availability of results of our clinical trials. In some cases, you
can identify these statements by forward-looking words such as
"anticipate," "believe," "may," "will," "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 earn milestone
payments under our collaboration agreement with Janssen, 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 September 30, 2018, 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.
View original
content:http://www.prnewswire.com/news-releases/protagonist-therapeutics-initiates-phase-1-trial-of-oral-gut-restricted-alpha-4-beta-7-integrin-antagonist-pn-10943-300764794.html
SOURCE Protagonist Therapeutics, Inc.