Iterum Therapeutics Provides Update from FDA Type A Meeting Regarding Oral Sulopenem
September 28 2021 - 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 that the Company held a Type A meeting
with the U.S. Food and Drug Administration (FDA) during the third
quarter of 2021 to discuss the steps required for potential
resubmission of the New Drug Application (NDA) for sulopenem
etzadroxil/probenecid (oral sulopenem) for the treatment of
uncomplicated urinary tract infections (uUTI).
In July, the Company announced that it had
received a Complete Response Letter (CRL) from the FDA requesting
additional data to support approval of oral sulopenem for the
treatment of adult women with a uUTI.
“We had a successful meeting with the FDA and
have established various potential paths forward to address the
request in the CRL for additional data in support of our NDA,” said
Corey Fishman, Chief Executive Officer. “We are currently
evaluating the optimal design for an additional Phase 3 uUTI study
to be conducted prior to the potential resubmission of the NDA. We
continue to believe in the ability of sulopenem to treat the
growing problem of multi-drug resistant UTIs in the community.”
Iterum notes that cash, cash equivalents
and short-term investments were $91.5 million at the end
of the second quarter of 2021. Based on the current operating plan
and subject to final determination of the design and planned
conduct of additional clinical and potential nonclinical
development for sulopenem, the Company believes that it is well
positioned financially to fund its operations into the second half
of 2023.
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 the Company’s plans, strategies
and prospects for its business, including with respect to planned
interactions and communications with the FDA and the ability to
reach agreement with the FDA on the design of any potential future
clinical trials, the Company’s expectations with regard to its
ability to resolve the matters set forth in the CRL and obtain
approval for oral sulopenem, the conduct of potential future
clinical and nonclinical development of sulopenem and the
sufficiency of the Company’s cash resources. 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 uncertainties inherent in the
initiation and conduct of clinical and nonclinical development,
including any additional trials that may be conducted in response
to the CRL, availability and timing of data from such clinical and
nonclinical 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, 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 impact of COVID-19 and related responsive measures thereto,
risks and uncertainties concerning the outcome, impact, effects and
results of the Company’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 the Company’s ability to
complete one at all and other factors discussed under the caption
“Risk Factors” in its Quarterly Report on Form 10- Q filed with the
Securities and Exchange Commission (the “SEC”) on August 13, 2021,
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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