NEWARK, Calif., Nov. 27, 2018 /PRNewswire/ -- Protagonist
Therapeutics, Inc. (Nasdaq:PTGX) today announced that the Company
plans to begin clinical development of PN-10943, an oral,
gut-restricted alpha-4-beta-7 integrin antagonist peptide for the
treatment of inflammatory bowel disease (IBD). In preclinical
studies, PN-10943 has demonstrated superior properties to PTG-100
as measured by in vitro potency, target engagement based on
in vivo pharmacodynamic (PD) readouts of blood receptor
occupancy (%RO) and effects on T cell trafficking, and efficacy in
disease models of colitis. The Company is replacing PTG-100 with
PN-10943 as a development candidate for the treatment of IBD based
on an assessment of preclinical data from PN-10943 and recent
feedback from global regulatory authorities on
further development of PTG-100.
"Because of the strength of our peptide technology platform, we
have had the flexibility to discover and evaluate PN-10943 as a
backup peptide with improved drug characteristics over PTG-100,"
commented Dinesh V. Patel, Ph.D.,
Protagonist President and Chief Executive Officer. "Based on the
superiority of PN-10943 in preclinical studies and recent feedback
from the FDA requesting an additional Phase 2 dose range finding
study with PTG-100, advancing PN-10943 into clinical development as
a replacement for PTG-100 is the most efficient allocation of
resources for the Company with minimal impact on overall
development timelines. We expect to begin a Phase 1 study of
PN-10943 in healthy volunteers by the end of 2018, with results of
the study expected in the first half of 2019. The safety,
pharmacokinetic (PK) and PD data from this study will be used to
design a Phase 2a study for PN-10943 in patients with ulcerative
colitis."
"Development of PN-10943 will enable us to incorporate knowledge
and experience acquired from our prior studies with PTG-100, which
has provided early evidence of safety and preliminary efficacy with
an oral, gut-restricted alpha-4-beta-7 integrin antagonist peptide
approach in patients with ulcerative colitis. Having achieved this
clinical proof-of-concept with PTG-100, we are now able to execute
on this validated approach with the more potent peptide PN-10943.
In addition, replacing PTG-100 in our pipeline provides greater
financial flexibility by now extending our cash runway to fund
operations by an additional six months to the end of 2020. This
projection assumes the receipt of a potential $25M milestone payment from Janssen and does not
include other potential milestone payments. From an overall
portfolio perspective, with our other assets besides PN-10943, we
expect to advance PTG-200 in a Phase 2 Crohn's study with Janssen,
and to obtain POC data in patients with PTG-300 before the end of
2020."
The planned PN-10943 Phase 1 study will be a randomized,
double-blind, placebo-controlled, dose escalation (100, 300, 1000
and 1400 mg) trial in 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 the administration of
PN-10943 over 14 consecutive days in escalating dose cohorts.
Primary endpoints for the study are safety and tolerability of
PN-10943. Secondary endpoints include evaluation of PK and PD
parameters of %RO.
A corporate update including a brief summary of preclinical data
of PN-10943 in comparison to PTG-100 and key milestones for all
development assets in the pipeline (PN-10943, PTG-200 and PTG-300)
will be provided on a conference call hosted by Protagonist.
Additional details from preclinical studies of PN-10943 will be
presented at a future medical conference.
Conference Call and Webcast Information
Protagonist executives will host a conference call and webcast
with slides available at 4:30 p.m.
ET/1:30 p.m. PT today. To
access the live call, dial 1-844-515-9178 (U.S./Canada) or 1-614-999-9313 (international) and
refer to conference ID number 1173975. The call will also be
webcast and will be accessible from "Events & Presentations" in
the Investors section of the company's website at
www.protagonist-inc.com. A replay will be available on the
company's website approximately two hours after the call and will
remain available for 60 days.
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-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 that is under development for treatment of
ulcerative colitis. 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. A global Phase 2 trial in
beta-thalassemia patients will be initiated by the end of 2018.
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, the timing of the initiation and availability
of results of our clinical trials and our potential milestone
payment receipt and cash runway. 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 to download
multimedia:http://www.prnewswire.com/news-releases/protagonist-therapeutics-announces-new-development-candidate-pn-10943-for-the-treatment-of-inflammatory-bowel-disease-300756297.html
SOURCE Protagonist Therapeutics, Inc.