NEWARK, Calif., Oct. 11, 2021 /PRNewswire/ -- Protagonist
Therapeutics, Inc. (Nasdaq: PTGX) ("Protagonist" or "the Company")
today announced that the U.S. Food and Drug Administration (FDA)
has removed the full clinical hold on the Company's rusfertide
clinical studies, announced on September 17,
2021. Per the FDA, dosing in all clinical studies of
rusfertide may be resumed.
The Company provided the FDA with all requested information as
the basis for a Complete Response and subsequent removal of the
clinical hold. In particular, the Company provided the requested
individual patient clinical safety reports, updated the
investigator brochure and patient informed consent forms, performed
a comprehensive review of the most recent safety database, and
included new safety and stopping rules in the study protocols. The
Company is working closely with study investigators and clinical
trial sites to resume dosing of patients in ongoing clinical trials
with rusfertide after patients have been reconsented.
The clinical hold was initially triggered by a recent
non-clinical finding in a 26-week rasH2 transgenic mouse model
indicating benign and malignant subcutaneous skin tumors. The rasH2
signal also prompted a re-examination of the four cases of cancer
observed across all rusfertide clinical trials involving over 160
patients, and a comprehensive review of the safety database,
including cases of suspected unexpected serious adverse reactions
(SUSAR). No additional cancer cases, and no other unexpected safety
signals, surfaced in this process.
"We are extremely pleased that the FDA has acted so quickly in
lifting the clinical hold on the rusfertide development program,
allowing us to resume patient dosing in our clinical studies," said
Dinesh Patel, Ph.D., President and Chief Executive Officer
of Protagonist. "Patient safety continues to be our topmost
priority. We believe that the cumulative evidence regarding the
safety and clinical risk-benefit of rusfertide is supportive of
expedited clinical development. We are actively preparing to
initiate the phase 3 registrational study for polycythemia vera in
the first quarter of 2022. Protagonist will continue to work
closely with the FDA to ensure patient safety with amendments to
current and planned future studies with rusfertide. We remain
optimistic about the future potential of rusfertide to address
unmet medical needs in excessive erythrocytosis and iron overload
related diseases like polycythemia vera and hereditary
hemochromatosis, respectively."
Conference Call and Webcast Information
A conference call will take place today, October 11, 2021, at 8:00
a.m. ET.
Live audio of the conference call will be simultaneously
broadcast over the internet. The call will be available to
investors, members of the news media, and the general public.
To access the live call, dial (877) 870-4263 (U.S./Canada) or (412) 317-0790 (international) five
minutes prior to the call and ask to be joined to the Protagonist
Therapeutics call. A live and archived webcast will be accessible
in the Investors section of the Company's website at
www.protagonist-inc.com.
About Protagonist Therapeutics
Protagonist Therapeutics is a biopharmaceutical company
with multiple peptide-based investigational new chemical entities
in different stages of development, all derived from the Company's
proprietary technology platform. Protagonist's pipeline includes
rusfertide (PTG-300), an investigational, injectable hepcidin
mimetic in a Phase 2 proof-of-concept clinical trial for
polycythemia vera (PV), a Phase 2 study in PV subjects with high
hematocrit levels, and a Phase 2 study for hereditary
hemochromatosis.
The Company is also evaluating an orally delivered,
gut-restricted alpha-4-beta-7 integrin specific antagonist peptide
(PN-943) currently in a Phase 2 study in adults with moderate to
severe active ulcerative colitis (UC). The Company is targeting
ulcerative colitis as the initial indication.
The Company has a worldwide license and collaboration agreement
with Janssen Biotech, Inc., for the development of oral peptide
IL-23 receptor antagonists. Compounds included in this agreement
are PTG-200, PN-235 and PN-232. PTG-200 is an orally delivered
interleukin-23 receptor specific antagonist peptide in a Phase 2
clinical trial for Crohn's disease. PN-235 and PN-232, both
second-generation oral interleukin-23 receptor antagonist
candidates, are currently in Phase 1 studies.
Protagonist is headquartered in Newark, California.
For further information, please
visit 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 Company's clinical development
program for rusfertide. 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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SOURCE Protagonist Therapeutics, Inc.