Iterum Therapeutics Announces Completion of Enrollment in Phase 3 Clinical Trial of Oral and IV Sulopenem in Complicated Urin...
November 18 2019 - 7:30AM
Iterum Therapeutics plc (Nasdaq: ITRM), 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
Sulopenem
for
Resistant
Enterobacteriaceae
(SURE) 2 clinical trial in complicated urinary tract infections
(cUTI).
“The completion of enrollment in our cUTI trial marks the
achievement of another critical milestone in our development
program,” said Corey Fishman, Chief Executive Officer of Iterum
Therapeutics. “Completing enrollment in this phase 3 trial brings
us another step closer to providing physicians and patients with
the first and only oral and intravenous (IV) penem antibiotic, if
approved. We look forward to sharing topline results from the SURE
2 trial in early 2020.”
This multi-center, double-blind clinical trial is measuring
efficacy, tolerability, and safety of IV and oral sulopenem for the
treatment of cUTI in adults. Patients are randomized to receive
either IV sulopenem once daily for a minimum of five days followed
by oral sulopenem/probenecid twice daily to complete 7-10 days of
treatment, or IV ertapenem once daily for a minimum of five days
followed by oral ciprofloxacin twice daily or, for those patients
with a baseline pathogen resistant to ciprofloxacin, to
amoxicillin/clavulanate twice daily.
About Complicated Urinary Tract Infections
There are approximately 3.6 million patients with cUTIs that
require antibiotic therapy every year in the United States. cUTIs,
including acute pyelonephritis, are defined as urinary tract
infections ascending from the bladder accompanied by local and
systemic signs and symptoms, including fever, chills, malaise,
flank pain, back pain, and/or costo-vertebral angle pain or
tenderness, that occur in the presence of a functional or
anatomical abnormality of the urinary tract or in the presence of
catheterization, with treatment typically initiated by IV therapy
in a hospital setting. The lack of effective oral step-down
options for many patients with cUTIs has meant the potential for
lengthy hospital stays or insertion of a peripherally inserted
central catheter (PICC) to facilitate administration of IV
antibiotics outside of the hospital.
About Sulopenem
Sulopenem, a novel penem anti-infective compound with oral and
IV formulations, has demonstrated potent in
vitro activity against a wide variety of gram-negative,
gram-positive and anaerobic bacteria resistant to other
antibiotics. If approved, sulopenem will help address the
significant clinical and economic need for new oral antibiotics
that enable the avoidance of hospitalization or facilitate early
hospital discharge by providing continuity-of-care step-down
therapy. The safety profile of IV sulopenem has been documented in
a Phase 2 program. Oral and IV sulopenem are being evaluated in
pivotal Phase 3 clinical trials of uncomplicated urinary tract
infections, complicated urinary tract infections and complicated
intra-abdominal infections.
The U.S. Food and Drug Administration (FDA) has granted Special
Protocol Agreements (SPA) and Qualified Infectious Disease Product
(QIDP) designations for oral and IV sulopenem in accordance with
the Generating Antibiotics Incentives Now (GAIN) Act, which will
provide five years of additional regulatory exclusivity and
expedited Fast Track FDA review.
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
oral and IV formulations. 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. For more
information, please visit http://www.iterumtx.com.
Forward-looking Statements
This press release may contain forward-looking statements. These
forward-looking statements include, without limitation, statements
regarding the development, therapeutic and market potential of
sulopenem and the timing, progress and results of clinical trials
and regulatory submissions. 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,” “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 Therapeutics’
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
Therapeutics’ control, including the uncertainties inherent in the
conduct of clinical trials, clinical trial patient enrollment,
availability and timing of data from clinical trials, changes in
regulatory requirements or decisions of regulatory authorities,
including uncertainties associated with regulatory review of
clinical trials and applications for marketing approval, changes in
public policy or legislation, the actions of third-party clinical
research organizations, suppliers and manufacturers,
commercialization plans and timelines, if approved, the sufficiency
of our cash resources and other factors discussed under the caption
“Risk Factors” in the Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commissions (SEC) on November 12, 2019, 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.
Investor Contact:Judy Matthews Chief
Financial Officer 312-778-6073IR@iterumtx.com
Media Contact:Claire LaCagnina 6 Degrees
315-765-1462 clacagnina@6degreespr.com
Iterum Therapeutics (NASDAQ:ITRM)
Historical Stock Chart
From Mar 2024 to Apr 2024
Iterum Therapeutics (NASDAQ:ITRM)
Historical Stock Chart
From Apr 2023 to Apr 2024