Summit Highlights Phase 3-Ready Precision Antibiotic Ridinilazole at IDWeek 2018
October 03 2018 - 3:00AM
Summit Therapeutics plc (‘Summit’ or the
’Company’)
Summit Highlights Phase 3-Ready Precision Antibiotic
Ridinilazole at IDWeek 2018
- Ridinilazole in Development to Treat C. difficile
Infection and Reduce Recurrent Disease
Oxford, UK, and Cambridge, MA, US, 3
October 2018 – Summit Therapeutics plc (NASDAQ: SMMT, AIM:
SUMM), a leader in new mechanism antibiotic innovation, is
highlighting ridinilazole’s potential as a front-line treatment for
C. difficile infection (‘CDI’) in a series of oral and poster
presentations at the infectious disease conference IDWeek 2018 in
San Francisco, CA. Ridinilazole is the Company’s most advanced new
mechanism antibiotic, which is expected to enter Phase 3 clinical
trials in the first quarter of 2019.
As are being outlined at IDWeek, the Phase 3
clinical trials of ridinilazole are designed not only to evaluate
ridinilazole in the treatment of CDI but also to show its impact on
reducing disease recurrence and in preserving the gut microbiome,
important determinants of public health impact. The effectiveness
of ridinilazole in the treatment of CDI and CDI recurrence will be
evaluated by measuring sustained clinical response (‘SCR’), which
is the primary endpoint for both of the two planned Phase 3
clinical trials.
“We believe that to have success in antibiotics,
we need to be bold and think differently. This is highlighted by
our Phase 3 clinical trial design for ridinilazole that aims to
show superiority of ridinilazole over vancomycin, the current
standard of care. The primary endpoint will measure how
ridinilazole can treat CDI and reduce recurrent CDI, the major
unmet need in this disease. Finally, we are incorporating health
economic outcomes measures that we believe will help support
premium pricing,” commented Dr David Roblin, President of
R&D of Summit. “If the Phase 3 clinical trial results
are positive, we believe these measures would differentiate
ridinilazole in CDI and support its front-line use.”
A summary of the information being presented at
IDWeek includes:
- Ridinilazole achieving statistical superiority over vancomycin
in the primary endpoint of SCR in a Phase 2 clinical trial called
CoDIFy; this superiority was driven by a large reduction in CDI
recurrence.
- Ridinilazole significantly preserved the gut microbiome of
patients with CDI in CoDIFy, which Summit believes led to the
reduction in recurrent CDI.
- The design of the ridinilazole Phase 3 clinical trials called
Ri-CoDIFy which will use the same primary endpoint of SCR.
- Ridinilazole’s activity is targeted to the site of infection.
Preclinical studies and Phase 1 and 2 clinical trials of
ridinilazole have shown negligible systemic exposure and levels of
drug in the colon and/or faeces significantly above the minimum
inhibitory concentration.
- A good safety profile with ridinilazole, being generally well
tolerated in prior clinical trials and non-clinical studies.
- Ridinilazole was significantly more potent against over 500
recent clinical isolates of C. difficile than vancomycin and
metronidazole, another commonly used CDI treatment, regardless of
ribotype or antibiotic resistance profile.
- Diagnostics are important for selective antibiotics, such as
ridinilazole, to ensure patients are treated with the right drug
for their infection. As was used in CoDIFy, a test for the toxins
produced by C. difficile will also be used in the Phase 3 clinical
trials to confirm that patients have CDI.
Copies of the presentations are available under
the Publications section of Summit’s website,
www.summitplc.com.
About C.
difficile InfectionC. difficile infection is a
serious healthcare threat in hospitals, long-term care homes and
increasingly in the wider community with over one million estimated
cases of CDI annually in the United
States and Europe. CDI is caused by an infection of the
colon by the bacterium C. difficile, which produces toxins
that cause inflammation and severe diarrhoea, and in the most
serious cases can be fatal. Patients typically develop CDI
following the use of broad-spectrum antibiotics that can cause
widespread damage to the natural gastrointestinal (gut) flora and
allow overgrowth of C. difficile bacteria. Existing CDI
treatments are predominantly broad-spectrum antibiotics, which
cause further damage to the gut flora and are associated with high
rates of recurrent disease. Reducing disease recurrence is the key
clinical issue in CDI as repeat episodes are typically more severe
and associated with an increase in mortality rates and healthcare
costs. The economic impact of CDI is significant with one study
estimating annual acute care costs at $4.8 billion in the
US.
About RidinilazoleRidinilazole
is a small molecule antibiotic that Summit is developing for the
treatment of CDI. In preclinical efficacy studies, ridinilazole
exhibited a targeted spectrum of activity that combined a potent
bactericidal effect against all clinical isolates of C.
difficile tested with minimal impact on other bacteria that
are typically found in the gut microbiome. In a Phase 2 proof of
concept trial in CDI patients, ridinilazole showed statistical
superiority in sustained clinical response ('SCR') rates compared
to the standard of care, vancomycin. In that trial, SCR was defined
as clinical cure at end of treatment and no recurrence of CDI
within 30 days of the end of therapy. Ridinilazole was also shown
to be highly preserving of the gut microbiome in the Phase 2 proof
of concept trial, which was believed to be the reason for the
improved clinical outcome for the ridinilazole-treated patients. In
addition, ridinilazole preserved the gut microbiome to a greater
extent than the marketed narrow-spectrum antibiotic fidaxomicin in
an exploratory Phase 2 clinical trial. Ridinilazole, an orally
administered small molecule, has received Qualified Infectious
Disease Product ('QIDP') designation and has been granted Fast
Track designation by the US Food and Drug Administration. The QIDP
incentives are provided through the US GAIN Act and include a
potential extension of marketing exclusivity for an additional five
years upon FDA approval.
About Summit Therapeutics
Summit Therapeutics is a leader in antibiotic innovation. Our new
mechanism antibiotics are designed to become the new standards of
care for the benefit of patients, and create value for payors and
healthcare providers. We are currently developing new mechanism
antibiotics for C. difficile infection and gonorrhoea and are using
our proprietary Discuva Platform to expand our pipeline. For more
information, visit www.summitplc.com and follow us on Twitter
@summitplc.
Contacts
Summit |
|
|
Glyn
Edwards / Richard Pye (UK office) |
Tel: |
44
(0)1235 443 951 |
Erik
Ostrowski / Michelle Avery (US office) |
|
+1
617 225 4455 |
|
|
|
Cairn Financial Advisers LLP (Nominated
Adviser) |
Tel: |
+44
(0)20 7213 0880 |
Liam
Murray / Tony Rawlinson |
|
|
|
|
|
N+1 Singer (Joint Broker) |
Tel: |
+44
(0)20 7496 3000 |
Aubrey Powell / Jen Boorer, Corporate FinanceTom Salvesen,
Corporate Broking |
|
|
|
|
|
Panmure Gordon (Joint Broker) |
Tel: |
+44
(0)20 7886 2500 |
Freddy Crossley, Corporate FinanceJames Stearns, Corporate
Broking |
|
|
|
|
|
MSL Group (US) |
Tel: |
+1
781 684 6557 |
Jon
Siegal |
|
summit@mslgroup.com |
|
|
|
Consilium Strategic Communications (UK) |
Tel: |
+44
(0)20 3709 5700 |
Mary-Jane Elliott / Jessica Hodgson / |
|
summit@consilium-comms.com |
Lindsey Neville |
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Summit Forward-looking Statements
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Company’s future expectations, plans and prospects, including but
not limited to, statements about the clinical and preclinical
development of the Company’s product candidates, the therapeutic
potential of the Company’s product candidates, the potential
commercialisation of the Company’s product candidates, the
sufficiency of the Company’s cash resources, the timing of
initiation, completion and availability of data from clinical
trials, the potential submission of applications for marketing
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materially from those indicated by such forward-looking statements
as a result of various important factors, including: the
uncertainties inherent in the initiation of future clinical trials,
availability and timing of data from ongoing and future clinical
trials and the results of such trials, whether preliminary results
from a clinical trial will be predictive of the final results of
that trial or whether results of early clinical trials or
preclinical studies will be indicative of the results of later
clinical trials, expectations for regulatory approvals, laws and
regulations affecting government contracts and funding awards,
availability of funding sufficient for the Company’s foreseeable
and unforeseeable operating expenses and capital expenditure
requirements and other factors discussed in the "Risk Factors"
section of filings that the Company makes with the Securities and
Exchange Commission, including the Company’s Annual Report on Form
20-F for the fiscal year ended 31 January 2018. Accordingly,
readers should not place undue reliance on forward-looking
statements or information. In addition, any forward-looking
statements included in this press release represent the Company’s
views only as of the date of this release and should not be relied
upon as representing the Company’s views as of any subsequent date.
The Company specifically disclaims any obligation to update any
forward-looking statements included in this press release.
-END-
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