Phase 2b
clinical trial of PN-235, an oral IL-23 receptor antagonist, has
launched with a target enrollment of 240 patients
NEWARK, Calif., March 16, 2022 /PRNewswire/ -- Protagonist
Therapeutics (Nasdaq: PTGX) ("Protagonist" or "the Company")
announced today earning a $25 million
milestone payment from its collaboration with Janssen Biotech, Inc.
(Janssen), following dosing of the third patient in the Phase
2b FRONTIER 1 clinical trial of
PN-235 (JNJ-77242113).
"The start of this Phase 2b study
in moderate-to-severe plaque psoriasis marks an exciting moment
along the development pathway for this promising drug candidate,
discovered through Protagonist's proprietary technology platform,"
said Dinesh V. Patel, Ph.D.,
President and CEO of Protagonist. "Advancing PN-235 aligns with our
shared goal with Janssen to develop new therapies with
transformational potential for patients in need."
FRONTIER 1 is a Phase 2b
multicenter, randomized, placebo controlled, dose-ranging study to
evaluate the safety and efficacy of PN-235 for the treatment of
moderate-to-severe plaque psoriasis. This study commenced on
February 3, 2022 and is expected to
enroll 240 participants. More information on FRONTIER 1 can be
found at clinicaltrials.gov.
Protagonist has granted Janssen an exclusive worldwide license
to research, develop and commercialize oral IL-23 receptor
antagonists based on the Company's intellectual property. Current
development efforts are centered on PN-235, discovered by
Protagonist and further developed in collaboration with
Janssen.
Protagonist is eligible for up to approximately $850 million in development-related milestone
payments, in addition to $112.5M in
milestones already earned. Under terms of the collaboration,
Janssen will conduct all future clinical studies, inclusive of
Phase 2 and 3 studies. Janssen will be financially responsible for
such studies.
About Protagonist
Protagonist Therapeutics is a biopharmaceutical company with
multiple peptide-based new chemical entities in different stages of
clinical development, all derived from the Company's proprietary
technology platform.
Protagonist's pipeline includes rusfertide, an investigational,
injectable hepcidin mimetic currently in the REVIVE Phase 2
proof-of-concept clinical trial for polycythemia vera (PV), the
PACIFIC Phase 2 study in PV subjects with high hematocrit levels,
and a recently completed Phase 2a study for hereditary
hemochromatosis. The Company is actively initiating VERIFY, a
single, global Phase 3 randomized, placebo-controlled trial
evaluating the efficacy and safety of a once weekly, subcutaneously
self-administered dose of rusfertide.
The Company is also evaluating an orally delivered,
gut-restricted alpha-4-beta-7 integrin specific antagonist peptide
(PN-943), currently in the IDEAL Phase 2 study in adults with
moderate to severe active ulcerative colitis. The Company is
targeting ulcerative colitis as the initial indication.
Protagonist has granted Janssen an exclusive worldwide license
to research, develop and commercialize oral IL-23 receptor
antagonists based on the Company's intellectual property. Current
development efforts are centered on PN-235, discovered by
Protagonist and further developed in collaboration with
Janssen.
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, future PN-235 clinical studies and
the potential for drug candidates developed in our Janssen
collaboration. 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 agreements, the
impact of the current COVID-19 pandemic on our discovery and
development efforts, 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. Additional information
concerning these and other risk factors affecting our business can
be found in our periodic filings with the Securities and Exchange
Commission, including under the heading "Risk Factors" contained in
our most recently filed periodic reports on Form 10-K and Form 10-Q
filed with the Securities and Exchange Commission. 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.
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