Iterum Therapeutics Announces Special Protocol Assessment (SPA) Agreement With the FDA
11 Julho 2022 - 8:30AM
Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company”), 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, announced today that it has reached an agreement with the
U.S. Food and Drug Administration (“FDA”) under the special
protocol assessment (“SPA”) process on the design, endpoints and
statistical analysis of a Phase 3 clinical trial for oral sulopenem
etzadroxil-probenecid (“oral sulopenem”) for the treatment of
uncomplicated urinary tract infections (“uUTI”). The SPA agreement
provides that the design and planned analysis of the trial, as set
out in the protocol submitted to the FDA, adequately addresses the
objectives necessary to support the potential resubmission of the
Company’s new drug application (“NDA") for oral sulopenem.
“We are pleased to have concluded discussions with the FDA and
reached agreement on key elements of the trial design to support
the potential resubmission of the NDA for oral sulopenem for uUTI
under the SPA process,” said Corey Fishman, Chief Executive
Officer. “The SPA underscores our alignment with the FDA on
important regulatory, clinical and scientific requirements for our
planned Phase 3 trial in uUTI and reflects our ongoing commitment
to bring this valuable therapy to market. We are excited about this
important milestone and are looking forward to starting recruitment
for this trial as soon as possible.”
The pivotal study to be conducted pursuant to the SPA agreement
is designed as a non-inferiority trial comparing oral sulopenem and
Augmentin® (amoxicillin/clavulanate) 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 study. The study
is expected to enroll approximately 1,966 patients and is
anticipated to start enrolling in the fourth quarter of 2022. Study
start-up activities have already been commenced by the Company to
enable timely initiation and recruitment.
About Special Protocol
Assessments
Under the SPA process, the FDA provides a clinical trial sponsor
with an official evaluation and written guidance on the design of a
proposed protocol intended to form the basis for an NDA. A SPA
agreement indicates concurrence by the FDA with the adequacy and
acceptability of specific critical elements of the overall protocol
design for a clinical trial intended to support a future marketing
application, but it does not indicate FDA concurrence on every
protocol detail. A SPA agreement also does not ensure the receipt
of marketing approval or that the approval process will be faster
than conventional procedures. A determination regarding marketing
approval is addressed during the review of a submitted NDA and
depends on efficacy and safety results and an evaluation of the
overall benefits and risks of treatment after review of the data
from the development program in its totality.
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 an oral formulation and 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 Therapeutics has received Qualified
Infectious Disease Product (QIDP) and Fast Track designations for
its oral and IV formulations of sulopenem in seven indications.
Forward-Looking Statements
This press release contains forward-looking statements. These
forward-looking statements include, without limitation, statements
regarding Iterum’s plans, strategies and prospects for its
business, including the timing and conduct of planned clinical and
non-clinical development of sulopenem to support a potential
resubmission of the NDA for oral sulopenem and Iterum’s
expectations with regard to its ability to resolve the matters set
forth in the complete response letter (CRL) received by Iterum in
July 2021 and obtain approval for oral sulopenem. 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 design,
initiation and conduct of clinical and non-clinical development,
including the planned additional clinical trial and non-clinical
development conducted in response to the CRL, availability and
timing of data from such clinical and non-clinical development,
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 including
completing potential additional clinical and non-clinical
development of oral sulopenem, the impact of COVID-19 and related
responsive measures thereto, 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
Annual Report on Form 10-Q filed with the Securities and Exchange
Commission (the “SEC”) on May 13, 2022, 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 Officer 312-778-6073IR@iterumtx.com
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