Iterum Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for Oral Sulopenem
November 30 2020 - 9:15AM
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 that it has submitted its New Drug
Application (NDA) to the U.S. Food and Drug Administration (FDA)
for sulopenem etzadroxil/probenecid (oral sulopenem) for the
treatment of uncomplicated urinary tract infections (uUTIs) in
patients with a quinolone non-susceptible pathogen.
“The submission of the NDA filing for oral sulopenem is a
significant step forward in bringing new antibiotics to patients to
help address the challenge of antibiotic resistance,” said Corey
Fishman, Chief Executive Officer. “Oral sulopenem, if approved,
would mean that physicians and patients have the opportunity to
benefit from the proven efficacy and safety of penem antibiotics
that, to date in the U.S., have only been available in IV
formulations. We are now one step closer to realizing the goal of
bringing this much needed medicine to the over six million patients
with cipro-resistant UTIs each year in the U.S.”
The NDA submission includes data from the SURE-1, SURE-2 and
SURE-3 phase 3 clinical trials, in which oral sulopenem was well
tolerated with no significant drug related adverse events. The
SURE-1 clinical trial (uUTIs) demonstrated statistical superiority
of oral sulopenem to the widely used comparator, ciprofloxacin, for
the primary efficacy endpoint of clinical and microbiologic
response at the test-of-cure visit for patients with a quinolone
non-susceptible pathogen.
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, among other things, timing of the
review of regulatory filings and the market opportunity for, and
potential market acceptance of, oral sulopenem for uUTIs, and the
Company’s plans, strategies and prospects for its business. 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
the Company’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 the
Company’s control, including the uncertainties inherent in the
initiation and conduct of clinical trials, availability and timing
of data from clinical trials, changes in regulatory requirements or
decisions of regulatory authorities, the timing of approval of any
submission, 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 the
Company’s expectations regarding how far into the future the
Company’s cash on hand will fund the Company’s ongoing operations,
the sufficiency of the Company’s cash resources and the Company’s
ability to continue as a going concern, the impact of COVID-19 and
related responsive measures thereto, the Company’s ability to
maintain listing on the Nasdaq Stock Market, risks and
uncertainties concerning the outcome, impact, effects and results
of the Company’s evaluation of corporate, organizational,
strategic, financial and financing alternatives, including the
terms, timing, structure, value, benefits and costs of any
corporate, organizational, strategic, financial or financing
alternative and the Company’s ability to complete one at all, the
price of the Company’s securities and other factors discussed under
the caption “Risk Factors” in its most recently filed Quarterly
Report on Form 10-Q, and other documents filed with the SEC from
time to time. Forward-looking statements represent the Company’s
beliefs and assumptions only as of the date of this press release.
Except as required by law, the Company 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 Officer312-778-6073IR@iterumtx.com
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