Iterum Therapeutics Provides Regulatory Update
May 11 2022 - 8:00AM
Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company”), a
clinical-stage pharmaceutical company focused on developing next
generation oral and IV antibiotics to treat infections caused by
multi-drug resistant pathogens in both community and hospital
settings, today announced it met with the US Food and Drug
Administration (“FDA”) on May 5, 2022, to discuss its proposed plan
to conduct one additional Phase 3 clinical trial to support the
potential resubmission of the Company’s new drug application
(“NDA") for oral sulopenem etzadroxil-probenecid (“oral sulopenem”)
for the treatment of uncomplicated urinary tract infections
(“uUTI”).
“We are pleased to announce that we have reached general
alignment with the FDA on key aspects of our proposed trial design
to support the potential resubmission of the NDA for uUTI,” said
Corey Fishman, Chief Executive Officer. “We are designing this
additional Phase 3 clinical trial as a non-inferiority trial
comparing oral sulopenem and Augmentin® (amoxicillin/clavulanate)
for the treatment of uUTI in adult women. We intend to request an
agreement with the FDA regarding the proposed protocol under the
special protocol assessment (“SPA”) process in the coming weeks and
subject to finalization and receipt of the SPA agreement, we plan
to initiate enrollment in the second half of 2022.”
A SPA agreement reflects the FDA’s concurrence with critical
design elements in a protocol but does not guarantee that the FDA
will file or approve an application that is supported by a clinical
trial that is conducted in accordance with such protocol received
from a sponsor.
About Iterum Therapeutics
plc
Iterum Therapeutics plc is a clinical-stage
pharmaceutical company dedicated to developing differentiated
anti-infectives aimed at combatting the global crisis of multi-drug
resistant pathogens to significantly improve the lives of people
affected by serious and life-threatening diseases around the world.
Iterum Therapeutics is advancing its first compound, sulopenem, a
novel penem anti-infective compound, in Phase 3 clinical
development with an oral formulation and IV formulation. Sulopenem
has demonstrated potent in vitro activity against a wide variety of
gram-negative, gram-positive and anaerobic bacteria resistant to
other antibiotics. Iterum Therapeutics has received Qualified
Infectious Disease Product (QIDP) and Fast Track designations for
its oral and IV formulations of sulopenem in seven indications.
Forward-Looking Statements
This press release contains forward-looking statements. These
forward-looking statements include, without limitation, statements
regarding Iterum’s plans, strategies and prospects for its
business, including with respect to planned interactions with the
FDA and Iterum’s ability to finalize a SPA agreement with the FDA,
Iterum’s expectations with regard to its ability to resolve the
matters set forth in the complete response letter (CRL) received by
Iterum in July 2021 and obtain approval for oral sulopenem, and the
design, timing and conduct of future clinical and non-clinical
development of sulopenem to support a potential resubmission of the
NDA for oral sulopenem. In some cases, forward-looking statements
can be identified by words such as “may,” “believes,” “intends,”
“seeks,” “anticipates,” “plans,” “estimates,” “expects,” “should,”
“assumes,” “continues,” “could,” “would,” “will,” “future,”
“potential” or the negative of these or similar terms and phrases.
Forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause Iterum’s actual
results, performance or achievements to be materially different
from any future results, performance or achievements expressed or
implied by the forward-looking statements. Forward-looking
statements include all matters that are not historical facts.
Actual future results may be materially different from what is
expected due to factors largely outside Iterum’s control, including
uncertainties inherent in the design, initiation and conduct of
clinical and non-clinical development, including any additional
clinical trials and non-clinical development conducted in response
to the CRL, availability and timing of data from such potential
clinical and non-clinical development, changes in regulatory
requirements or decisions of regulatory authorities, the timing or
likelihood of regulatory filings and approvals, including any
potential resubmission of the NDA for oral sulopenem, changes in
public policy or legislation, commercialization plans and
timelines, if oral sulopenem is approved, the actions of
third-party clinical research organizations, suppliers and
manufacturers, the accuracy of Iterum’s expectations regarding how
far into the future Iterum’s cash on hand will fund Iterum’s
ongoing operations including completing potential additional
clinical and non-clinical development of oral sulopenem, the impact
of COVID-19 and related responsive measures thereto, Iterum’s
ability to maintain its listing on the Nasdaq Stock Market, risks
and uncertainties concerning the outcome, impact, effects and
results of Iterum’s evaluation of corporate, strategic, financial
and financing alternatives, including the terms, timing, structure,
value, benefits and costs of any corporate, strategic, financial or
financing alternative and Iterum’s ability to complete one at all
and other factors discussed under the caption “Risk Factors” in its
Annual Report on Form 10-K filed with the Securities and Exchange
Commission (the “SEC”) on March 28, 2022, and other documents filed
with the SEC from time to time. Forward-looking statements
represent Iterum’s beliefs and assumptions only as of the date of
this press release. Except as required by law, Iterum assumes no
obligation to update these forward-looking statements publicly, or
to update the reasons actual results could differ materially from
those anticipated in the forward-looking statements, even if new
information becomes available in the future.
Investor Contact:Judy
MatthewsChief Financial Officer 312-778-6073IR@iterumtx.com
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