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 sulopenem did not achieve statistical
non-inferiority relative to ertapenem in its
SUlopenem for
Resistant
Enterobacteriaceae (SURE) 2 clinical trial in
complicated urinary tract infection (cUTI).
The primary U.S. Food and Drug Administration (FDA) endpoint was
overall clinical and microbiologic response on Day 21 in the
micro-MITT population as evaluated using a 10% non-inferiority
margin.
The randomized, multi-center, double-blind SURE 2 clinical trial
enrolled 1,395 patients to measure the efficacy, tolerability, and
safety of IV and oral sulopenem for the treatment of cUTI in
adults. Patients were randomized to receive either IV sulopenem
once daily for a minimum of five days followed by oral sulopenem
twice daily to complete seven to ten days of treatment, or IV
ertapenem once daily for a minimum of five days followed by either
oral ciprofloxacin or, for quinolone resistant isolates,
amoxicillin-clavulanate twice daily. Responder rates at the test of
cure visit for sulopenem were 67.8% (301 of 444 patients) and for
ertapenem were 73.9% (325 of 440 patients) with a difference of
-6.1% (95% confidence interval (CI): -12.0%, - 0.1%). The
difference in response rates was driven almost entirely by higher
rates of asymptomatic bacteriuria on sulopenem relative to
ertapenem, only evident at the test of cure visit; the rates of
patients receiving additional antibiotics or with residual cUTI
symptoms was similar. Clinical response at the test of cure in the
Modified Intent to Treat patient population (sulopenem vs
ertapenem: 2.0% (95% CI: -1.5, 5.4%) and Clinically Evaluable
patient population (sulopenem vs ertapenem: 0.4% (95% CI: -2.6%,
3.5%) was similar. The outcome at other secondary endpoints was
also similar, including the overall response at the end of therapy
visit at Day 10, (sulopenem: 385 of 444 patients (86.7%);
ertapenem: 391 of 440 patients (88.9%).
“We are very disappointed by the outcome in the cUTI study,
although sulopenem was well tolerated and demonstrated a safety
profile consistent with previous studies and the penem class in
general,” said Corey Fishman, Chief Executive Officer of Iterum
Therapeutics. Based on these trial results, Iterum Therapeutics is
evaluating its corporate, strategic and financial alternatives with
the goal of maximizing value for its stakeholders while prudently
managing its remaining resources. These alternatives could
potentially include the licensing, sale or divestiture of the
company’s assets or proprietary technologies, a sale of the
company, a merger or other business combination, another strategic
transaction involving the company, restructuring activities,
winding down of operations, dissolving and liquidating assets or
seeking protection under bankruptcy laws. The evaluation of
corporate, strategic and financial alternatives may not result in
any particular action or any transaction being pursued, entered
into or consummated, and there is no assurance as to the timing,
sequence or outcome of any action or transaction or series of
actions or transactions.
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. The safety profile of IV sulopenem has been documented
in a Phase 2 program. Given these results, Iterum Therapeutics
initiated three pivotal Phase 3 clinical trials of oral and IV
sulopenem for uncomplicated urinary tract infections, complicated
urinary tract infections and complicated intra-abdominal
infections.
The 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 allow for 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. 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 contains forward-looking statements. These
forward-looking statements include, without limitation, statements
regarding the development, therapeutic and market potential of
sulopenem and our evaluation of corporate, strategic and financial
alternatives. 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,
commercialization plans and timelines, if approved, the actions of
third-party clinical research organizations, suppliers and
manufacturers, 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, the impact of COVID-19 and related responsive
measures thereto, risks and uncertainties concerning the outcome,
impact, effects and results of our evaluation of corporate,
strategic and financial alternatives, including the terms, timing,
structure, value, benefits and costs of any corporate, strategic or
financial alternative and our ability to complete one at all, risks
and uncertainties related to the impact of this announcement on our
business, financial condition, results of operations and the price
of our securities and other factors discussed under the caption
“Risk Factors” in its most recently filed Quarterly Report on Form
10-Q, 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
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