REG-Arix Bioscience plc: Iterum announces topline Phase 3 data

Arix BioscienceAnnouncement

11/12/2019 07:10

Arix Bioscience plc

Iterum announces topline Phase 3 data

LONDON, 11 December 2019: Arix Bioscience plc (“Arix”, LSE: ARIX), a
global venture capital company focused on investing in and building
breakthrough biotech companies, today notes that its portfolio company, Iterum
Therapeutics plc (Nasdaq: ITRM) (“Iterum”), announced topline results from
one of its three Phase 3 trials for sulopenem, Iterum’s lead compound and
novel antibiotic for the treatment of gram-negative, multi-drug resistant
infections.

The full body of evidence from the trial, known as Sulopenem for Resistant
Enterobacteriaceae (SURE) 3, confirms overall safety profile and suggests that
treatment with sulopenem may result in clinically important benefits in
complicated intra-abdominal infections, the second leading cause of
infection-related mortality in intensive care units. However, the trial
narrowly missed its primary endpoint of clinical response on Day 28 in the
micro-MITT 1  population, by one patient.

As reported by Iterum, results from its SURE 1 and SURE 2 Phase 3 trials for
complicated and uncomplicated urinary tract trials are expected to read out in
Q1 2020.

The announcement can be accessed on Iterum’s investor website at
https://ir.iterumtx.com/press-releases and full text of the announcement from
Iterum is contained below.

 ENDS 

Enquiries

For more information on Arix, please contact:

Arix Bioscience plc

Charlotte Parry, Head of Investor Relations

Tel: +44 (0)20 7290 1072

charlotte@arixbioscience.com  

Media Enquiries

Optimum Strategic Communications 

Mary Clark/ Supriya Mathur

 1  MicroMITT population: Microbiological modified intent-to-treat population

optimum.arix@optimumcomms.com

Tel: +44 (0) 203 950 9144

About Arix Bioscience plc

Arix Bioscience plc is a global venture capital company focused on investing
in and building breakthrough biotech companies around cutting edge advances in
life sciences. We collaborate with exceptional entrepreneurs and provide the
capital, expertise and global networks to help accelerate their ideas into
important new treatments for patients. As a listed company, we are able to
bring this exciting growth phase of our industry to a broader range of
investors. www.arixbioscience.com

Iterum Therapeutics Announces Topline Results from Phase 3 Clinical Trial of
Oral and IV Sulopenem for the Treatment of Complicated Intra-abdominal
Infections

DUBLIN, Ireland and CHICAGO; December 10, 2019 -- Iterum Therapeutics plc
(Nasdaq: ITRM), a clinical-stage pharmaceutical company focused on developing
an oral and IV penem antibiotic to treat infections caused by multi-drug
resistant pathogens in both community and hospital settings, today announced
topline results from its Sulopenem for Resistant Enterobacteriaceae (SURE) 3
clinical trial in complicated intra-abdominal infections (cIAI).

The primary U.S. Food and Drug Administration (FDA) endpoint was clinical
response on Day 28 in the micro-MITT population. In this population, the
difference in outcomes was 4.7% with a 95% confidence interval on that
difference of -10.3% to 1.0%. Non-inferiority required that the lower limit of
the difference in the outcome rates be >-10% for FDA.

                              Sulopenem  Ertapenem  Difference  (95% Confidence Interval)  
 Test of Cure                                                                              
                    microMITT   85.5%      90.2%              -4.7% (-10.3, 1.0)           
                         MITT   87.2%      90.0%              -2.9% (- 7.7, 2.0)           
         Clinically Evaluable   93.5%      95.7%              -2.0% (-5.7, 1.7)            
  Microbiologically Evaluable   92.5%      95.5%              -3.0% (-7.5, 1.4)            
 End of Treatment                                                                          
                    microMITT   83.5%      85.3%              -1.8% (- 8.1, 4.5)           
                         MITT   83.7%      85.4%              -1.7% (-7.1, 3.8)            
         Clinically Evaluable   89.4%      90.0%              -0.7% (-5.6, 4.3)            
  Microbiologically Evaluable   88.5%      88.9%              -0.4% (-6.3, 5.4)            

In a prespecified multiple imputation analysis designed to address any
imbalances in patients with indeterminate outcomes at the test of cure in the
microMITT population, the difference in outcomes was 4.7% with a 95%
confidence interval on that difference of -9.9% to 0.5%.

In the safety population of 668 patients, treatment related adverse events
were observed in 6.0% and 5.1% of patients on sulopenem and ertapenem,
respectively, with the most commonly reported drug-related adverse event being
diarrhea at 4.5% and 2.4%. Discontinuations were uncommon on both regimens
seen in 1.5% of patients on sulopenem and 2.1% of patients on ertapenem.
Serious adverse events unrelated to study treatment were seen in 7.5% of
patients on sulopenem and 3.6% of patients on ertapenem.

“While the difference in the primary outcome is one patient shy of the
target of -10%, imputing an outcome for the patients with missing data and the
secondary supporting analyses, both at the end of treatment as well as the
test of cure, provide support for the potential of sulopenem in the treatment
of multi-drug resistant infections,” said Michael Dunne, MD, Chief
Scientific Officer at Iterum Therapeutics. “Over 10% of the patients in this
study had a gram-negative pathogen that was resistant to both quinolones and
?-lactams, the two classes of oral agents that are most commonly used for step
down therapy for this indication. In this era of rapidly emerging multi-drug
resistance, we believe the availability of sulopenem in its oral and IV
formulations would provide the healthcare system with a much needed option for
step-down therapy from hospital to home.”

“We believe that these topline results, while narrowly missing the primary
endpoint, provide data that emphasize the potential for sulopenem to help
address the growing challenge of antibiotic resistance,” said Corey Fishman,
Chief Executive Officer of Iterum Therapeutics.  “If we obtain positive
results in Q1 2020 from our Phase 3 complicated and uncomplicated urinary
tract trials, we believe that the overall safety and efficacy results from
this cIAI trial would be supportive in an FDA filing for oral and IV sulopenem
and that sulopenem’s market potential remains robust.”

The multi-center, double-blind SURE 3 randomized patients with cIAI to receive
either IV sulopenem once daily for a minimum of five days followed by oral
sulopenem/probenecid twice daily to complete 7 to10 total days of treatment,
or IV ertapenem once daily for a minimum of five days followed by oral
ciprofloxacin twice daily along with oral metronidazole four times daily or,
for those patients with ciprofloxacin-resistant organism at baseline,
amoxicillin-clavulanate twice daily. The primary endpoint was based on
clinical response at Day 28 in patients with a positive intra-abdominal
culture at baseline, consistent with recent FDA Guidelines for Development of
Drugs for intra-abdominal infections. Clinical outcome at Day 28 was noted as
cure for those patients who were alive, had resolution in signs and symptoms
of the index infection and for whom no new antibiotics or interventions for
treatment failure were required.

About Complicated Intra-abdominal Infections

cIAIs are the second leading cause of infection-related mortality in intensive
care units.(1) IAI is a broad term that encompasses a number of infections,
including peritonitis, diverticulitis, cholecystitis, cholangitis, and
pancreatitis. These complicated infections extend from a gastrointestinal
source, such as the appendix or the colon, into the peritoneal space and can
be associated with abscess formation. Among approximately 350,000 cIAI
patients in the United States each year, broad spectrum antibiotics are
generally administered as first line treatment; treatment failure is more
common due to the serious nature of these infections. Carbapenems are
recommended by the Infectious Disease Society of America (IDSA) guidelines for
empiric treatment of intra-abdominal infections.

(1) https://www.uspharmacist.com/article/intraabdominal-infections-in-adults

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. Given these results, oral and IV
sulopenem are being evaluated in three pivotal Phase 3 clinical trials of
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 provides 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 Iterum
Therapeutics’ cash resources and its ability to continue as a going concern,
and other factors discussed under the caption “Risk Factors” in Iterum
Therapeutics’ most recently filed Quarterly Report on Form 10-Q filed with
the Securities and Exchange Commission (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
312-778-6073

IR@iterumtx.com     



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