Iterum Therapeutics Announces Completion of Enrollment in its REASSURE Phase 3 Clinical Trial of Oral Sulopenem in Uncomplicated Urinary Tract Infections
October 24 2023 - 7:00AM
Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), 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 the completion of patient enrollment in its REASSURE
(
REnewed
ASsessment of
Sulopenem in u
UTI caused by
Resistant
Enterobacterales)
clinical trial comparing oral sulopenem (sulopenem etzadroxil
combined with probenecid in a bilayer tablet) to oral Augmentin®
(amoxicillin/clavulanate) in adult women with uncomplicated urinary
tract infections (uUTI).
“We are extremely pleased to have completed enrollment in our
REASSURE trial well ahead of schedule. We now expect topline
results early in the first quarter of 2024, and subject to our
analysis of the data, plan to resubmit our NDA to the FDA in the
second quarter of 2024,” said Corey Fishman, Chief Executive
Officer. “This significant milestone represents another exciting
step forward in the development of oral sulopenem and potentially
bringing to market the first antibiotic approved for the treatment
of uUTIs in over 25 years, as well as the first oral penem, in the
U.S.”
Iterum expects to report topline data early in the first quarter
of 2024 and, subject to its analysis of the data, to resubmit its
New Drug Application (NDA) for oral sulopenem for the treatment of
uUTIs to the U.S. Food and Drug Administration (FDA) in the second
quarter of 2024. Provided that the resubmitted NDA addresses all of
the deficiencies identified in the complete response letter Iterum
received from the FDA in July 2021, Iterum expects that the FDA
will complete its review and take action six months from the date
the FDA receives the resubmitted NDA (or during the second half of
2024).
About REASSURE
The REASSURE trial is designed as a non-inferiority trial
comparing oral sulopenem and Augmentin® in the Augmentin
susceptible population and is entitled “A prospective, Phase 3,
randomized, multi-center, double-blind study of the efficacy,
tolerability, and safety of oral sulopenem etzadroxil/probenecid
versus oral amoxicillin/clavulanate for treatment of uncomplicated
urinary tract infections (uUTI) in adult women.” Patients were
randomized to receive either oral sulopenem twice daily for 5 days
or Augmentin® twice daily for 5 days. The primary endpoint is the
overall response (clinical and microbiologic combined response) at
the test of cure visit. The trial enrolled approximately 2,230
patients and is being conducted under a special protocol assessment
(SPA) agreement with the FDA.
For more information on REASSURE, please refer to
www.clinicaltrials.gov using the identifier NCT05584657.
About Urinary Tract Infections (UTIs)
UTIs are among the most common bacterial infections encountered
in the community. There are approximately 15 million emergency
room and office visits for symptoms of urinary tract infections and
approximately 33 million uUTIs treated in the United States
annually, with approximately 30% of those infections caused by a
quinolone non-susceptible organism, and approximately 1% of those
infections caused by pathogens that are resistant to all commonly
available classes of oral antibiotics. As a result, the treatment
of UTIs has become more challenging because of the development of
resistance by pathogens responsible for these infections. uUTIs are
infections of the bladder occurring mainly in women. 50% of all
women experience at least one UTI at some point in their lives.
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 is
currently advancing its first compound, sulopenem, a novel penem
anti-infective compound, in Phase 3 clinical development with an
oral formulation. Sulopenem also has an 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 has received Qualified Infectious Disease
Product (QIDP) and Fast Track designations for its oral and IV
formulations of sulopenem in seven indications, including uUTI. For
more information, please visit http://www.iterumtx.com.
Special Note Regarding Forward Looking
Statements
This press release contains forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995. These forward-looking statements include, without limitation,
statements regarding the development, therapeutic and market
potential of sulopenem, the timing and results of topline data from
the REASSURE clinical trial, our ability to address the
deficiencies set out in the complete response letter received in
July 2021 and the expected timing of resubmission of the NDA. 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 conduct
of clinical and non-clinical development, including the REASSURE
clinical trial, availability and timing of data from the REASSURE
clinical trial, changes in regulatory requirements or decisions of
regulatory authorities, the timing or likelihood of regulatory
filings and approvals, including the 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, Iterum’s
ability to maintain its listing on the Nasdaq Capital 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
Quarterly Report on Form 10-Q filed with the SEC on August 11,
2023, 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
Officer312-778-6073IR@iterumtx.com
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