Iterum Therapeutics Announces Positive Pre-NDA Meeting with FDA for Sulopenem for Treatment of Uncomplicated Urinary Tract In...
September 30 2020 - 7:00AM
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 that, based on discussions at a pre-NDA
meeting with the U.S. Food and Drug Administration ("FDA"), it
plans to proceed with an NDA submission for sulopenem
etzadroxil/probenecid, a bilayer tablet, for the treatment of
uncomplicated urinary tract infections (uUTI) in patients with a
quinolone-resistant pathogen.
“We are pleased with the collaborative tone of our meeting with
the FDA, and we believe that we now have a solid understanding of
the Agency's requirements for our submission and the focus of their
review,” said Corey Fishman, Chief Executive Officer. “Based on
feedback received during this meeting and from previous
correspondence, we have confidence in our decision to move forward
with our NDA package for sulopenem etzadroxil/probenecid for the
treatment of uUTI due to quinolone-resistant pathogens. We estimate
that there are over 6 million quinolone-resistant urinary tract
infections annually in the U.S., many of which are also multi-drug
resistant, and sulopenem has demonstrated superiority versus
ciprofloxacin in treating these infections.”
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, the Company’s
plans to move forward with its NDA package for sulopenem
etzadroxil/probenecid, the timing of preparation of such NDA
submission, the FDA requirements for such NDA submission 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 Company’s ability to apply
for regulatory approval and the timing of approval of any
submission, changes in public policy or legislation,
commercialization plans and timelines, if 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 Officer 312-778-6073IR@iterumtx.com
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