Iterum Therapeutics Provides Update on Phase 3 Clinical Trials of Sulopenem in Complicated Urinary Tract Infection (cUTI) and...
March 31 2020 - 7:00AM
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 that it anticipates reporting topline results from its
Sulopenem
for
Resistant
Enterobacteriaceae
(SURE) 1 clinical trial in uUTI and SURE 2 clinical trial in cUTI
in the early part of the second quarter of 2020.
As previously announced, patient enrollment and
treatment for SURE 1 and SURE 2 clinical trials were completed in
early 2020.
“Despite the COVID-19 pandemic, we are working
closely with our partners as they complete the processing of data
and wrap-up the final steps necessary to enable us to report
topline results from these clinical trials as close as possible to
our original timeline of around the end of the first quarter,” said
Corey Fishman, Chief Executive Officer of Iterum Therapeutics. “We
look forward to sharing results in the near-term and remain
confident in the potential of sulopenem to become the first and
only oral and IV penem antibiotic treatment option to help address
the ongoing, global threat caused by multi-drug resistant
infections impacting both hospital and community settings.”
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 for 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. 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 our 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 our control, including the uncertainties inherent in the
conduct of clinical trials, availability and timing of data from
clinical trials, changes in regulatory requirements or decisions of
regulatory authorities, changes in public policy or legislation,
the actions of third-party clinical research organizations,
suppliers and manufacturers, commercialization plans and timelines,
if approved, the accuracy of our expectations regarding how far
into the future our cash on hand will fund our ongoing operations,
the sufficiency of our cash resources and our ability to continue
as a going concern, risks related to political, economic or
business conditions, including risks related to health epidemics
and other widespread outbreaks of contagious disease, including the
novel coronavirus and other factors discussed under the caption
“Risk Factors” in our Annual Report on Form 10-K filed with the
Securities and Exchange Commission (the “SEC”), and other documents
filed with the SEC from time to time. Forward-looking statements
represent our beliefs and assumptions only as of the date of this
press release. Except as required by law, we assume 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 315-765-1462lacagnina@6degreespr.com
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