Iterum Announces First Patient Dosed in REASSURE, a Phase 3 Clinical Trial of Oral Sulopenem in Uncomplicated Urinary Tract Infections
October 20 2022 - 7:30AM
Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), a clinical-stage
pharmaceutical company developing antibiotics to treat infections
caused by multi-drug resistant pathogens, today announced that the
first patient has been dosed in its Phase 3 clinical trial, known
as
REnewed
ASsessment of
Sulopenem in u
UTI caused by
Resistant
Enterobacterales
(REASSURE), 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 pleased to have successfully dosed our first patient in
our Phase 3 clinical trial for oral sulopenem for the treatment of
uUTI, which is being conducted under a Special Protocol Assessment
(SPA) agreement with the U.S. Food and Drug Administration (FDA),”
said Corey Fishman, Chief Executive Officer. “We anticipate
completing the trial in the first half of 2024 with our existing
cash resources. With positive results, we would resubmit our new
drug application (NDA) to the FDA in 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 will be
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
Day 12 of the trial. The trial is expected to enroll approximately
1,966 patients and is being conducted under a SPA agreement with
the FDA.
Iterum expects to complete enrollment in the first half of 2024
and, if the Phase 3 clinical trial is successful, resubmit its NDA
in the second half of 2024. If the resubmission addresses all
deficiencies in the complete response letter received in July 2021
from the FDA, then the FDA’s review and action will occur six
months from receipt of the resubmission.
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 antibiotics 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 advancing its
first compound, sulopenem, a novel penem antibiotic with oral and
IV formulations that 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.
Forward-looking Statements
This press release contains forward-looking
statements. These forward-looking statements include, without
limitation, statements regarding the development, therapeutic and
market potential of sulopenem, the timing, conduct, progress and
results of Iterum’s ongoing Phase 3 clinical trial, Iterum’s
expectations with regard to its ability to resolve matters set
forth in the complete response letter (CRL) received by Iterum in
July 2021 and obtain approval for oral sulopenem, the expected
timing of resubmission of the NDA, and the sufficiency of Iterum’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,” “will,” “would,” “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 the uncertainties inherent in the
initiation and conduct of clinical and non-clinical development,
including the Phase 3 clinical trial and non-clinical development
being conducted in response to the CRL, clinical trial patient
enrolment, availability and timing of data from the Phase 3
clinical trial and non-clinical development, changes in regulatory
requirements or decisions of regulatory authorities, the timing or
likelihood of regulatory filing 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, the impact of COVID-19 and related responsive
measures thereto, 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 financial alternatives 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, which was filed with the Securities and Exchange Commission
(SEC) on August 12, 2022, and other documents filed with the SEC
from time to time. Forward-looking statements represent Iterum
Therapeutics’ beliefs and assumptions only as of the date of this
press release. Except as required by law, Iterum Therapeutics
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.
Contact:
Contact:Judy MatthewsChief Financial
Officer312-778-6073IR@iterumtx.com
Iterum Therapeutics (NASDAQ:ITRM)
Historical Stock Chart
From Aug 2024 to Sep 2024
Iterum Therapeutics (NASDAQ:ITRM)
Historical Stock Chart
From Sep 2023 to Sep 2024