Iterum Therapeutics Receives Complete Response Letter from U.S. Food and Drug Administration for Oral Sulopenem
July 26 2021 - 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 it received a Complete Response
Letter (CRL) from the U.S. Food and Drug
Administration (FDA) for its New Drug Application (NDA) for
sulopenem etzadroxil/probenecid (oral sulopenem) on July 23,
2021. The CRL provided that the FDA has completed its review of the
NDA and has determined that it cannot approve the NDA in its
present form.
In the CRL, the FDA acknowledged that the Phase
3 SURE-1 clinical trial demonstrated statistical significance in
difference in overall response rate of oral sulopenem compared to
ciprofloxacin in the ciprofloxacin-resistant population. However,
the FDA determined that additional data are necessary to support
approval for the treatment of adult women with uncomplicated
urinary tract infections caused by designated susceptible
microorganisms proven or strongly suspected to be non-susceptible
to a quinolone. The FDA recommended that Iterum conduct at least
one additional adequate and well-controlled clinical trial,
potentially using a different comparator drug. Additionally, the
FDA recommended that Iterum conduct further nonclinical
investigation to determine the optimal dosing regimen, although the
FDA stated that this recommendation does not raise an approvability
issue. The FDA indicated its willingness to work with Iterum on the
design of the clinical trial(s) to address the deficiencies
noted.
There were no chemistry, manufacturing or
controls (CMC) issues identified in the CRL, nor were there any
safety issues found in over 1,800 patients treated with sulopenem
across the Company’s clinical development program.
“We are disappointed in this outcome and
believe that the data package submitted was adequate for
the approval of oral sulopenem,” said Corey Fishman, Chief
Executive Officer. “Regardless, we will evaluate the points
raised in the CRL for discussion with the FDA to determine an
expeditious path forward. We remain confident in the value of, and
unmet medical need for, oral sulopenem to treat multi-drug
resistant infections, including fast-growing quinolone
non-susceptible pathogens.”
Iterum intends to review the CRL with its
advisors and plans to request a Type A meeting in the coming weeks.
Following the Type A meeting, anticipated to be late in the third
quarter, Iterum expects to provide an update on next
steps as to the potential additional clinical and non-clinical work
to be done prior to a resubmission of the NDA for approval of oral
sulopenem.
Iterum notes that cash, cash equivalents
and short-term investments were $100.5 million at the end
of the first 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, 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 future clinical and potential 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 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 May 14, 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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