Summit Recognises C. difficile Awareness Month
01 November 2018 - 6:00PM
Summit Therapeutics plc (‘Summit’ or the
’Company’)
Summit Recognises C. difficile Awareness Month
Oxford, UK, and Cambridge, MA, US, 1 November
2018 – Summit Therapeutics plc (NASDAQ: SMMT, AIM: SUMM), a
leader in new mechanism antibiotic innovation, recognises C.
difficile Awareness Month, which highlights the common, but largely
unknown C. difficile infection (CDI) throughout the month of
November. C. difficile infects over one million patients in the US
and Europe each year, causing inflammation and severe diarrhoea
that can be fatal. Summit is developing the Phase 3-ready precision
antibiotic ridinilazole to address both the initial infection and
importantly the key unmet need of reducing recurrence of CDI.
As part of CDI Awareness Month, Summit is
presenting on ridinilazole and its Phase 3 clinical trial plans at
the 6th Annual International C. diff Conference and Health Expo
taking place 8-9 November 2018 in Philadelphia, PA.
“We lose over 40 patients a day to CDI in the
US. The current standard of care fails to fully address the major
burden CDI places on patients, their families and healthcare
systems, and new treatment options are desperately needed,” said
Nancy C. Caralla, Founding President and Executive Director of the
C Diff Foundation. “The biggest need in CDI is reducing
recurrence of the disease, as with each CDI episode, we see
increasing severity, morbidity and mortality. A targeted therapy
used upfront could help to reduce recurrence and provide a better
overall outcome for patients. We are excited to see Summit’s
ridinilazole advancing into Phase 3 clinical trials.”
“The landscape of infectious diseases is
shifting towards precision medicine – using a specific drug for a
specific infection. CDI is a textbook example whereby
broad-spectrum antibiotics exacerbate the problem both in causing
the initial disease and in driving recurrence,” said Dr David
Roblin, President of R&D of Summit. “We believe
ridinilazole has the potential to significantly improve the CDI
landscape as a front-line treatment and look forward to initiating
our planned Phase 3 clinical trials in the first quarter of
2019.”
The US Centers for Disease Control and
Prevention lists C. difficile as an urgent public health threat
that requires aggressive action. Most cases of CDI are directly
related to prior antibiotic use for unrelated infections, which
damages the gut microbiome that could otherwise protect against
CDI. The current standard of care, vancomycin, is a broad-spectrum
antibiotic, meaning that it indiscriminately kills bacteria,
including the protective bacteria in the gut microbiome, and leaves
patients susceptible to CDI recurrence. Ridinilazole is designed to
selectively kill C. difficile and preserve the protective gut
microbiome to reduce CDI recurrence and sustain cures. These
characteristics were observed in a Phase 2 clinical trial where
ridinilazole demonstrated statistical superiority over vancomycin
in sustained clinical response.
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 |
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Glyn Edwards / Richard Pye (UK
office) |
Tel: |
44 (0)1235 443 951 |
Erik Ostrowski / Michelle Avery (US
office) |
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+1 617 225 4455 |
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Cairn Financial Advisers LLP
(Nominated Adviser) |
Tel: |
+44 (0)20 7213 0880 |
Liam Murray / Tony Rawlinson |
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|
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N+1 Singer (Joint Broker) |
Tel: |
+44 (0)20 7496 3000 |
Aubrey Powell / Jen Boorer, Corporate
FinanceTom Salvesen, Corporate Broking |
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|
|
|
|
Panmure Gordon (Joint Broker) |
Tel: |
+44 (0)20 7886 2500 |
Freddy Crossley, Corporate FinanceJames
Stearns, Corporate Broking |
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|
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MSL Group (US) |
Tel: |
+1 781 684 6557 |
Jon Siegal |
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summit@mslgroup.com |
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Consilium Strategic Communications
(UK) |
Tel: |
+44 (0)20 3709 5700 |
Mary-Jane Elliott / Jessica Hodgson / Sue
Stuart / |
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summit@consilium-comms.com |
Lindsey Neville |
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Summit Forward-looking Statements
Any statements in this press release about the
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
approvals and other statements containing the words "anticipate,"
"believe," "continue," "could," "estimate," "expect," "intend,"
"may," "plan," "potential," "predict," "project," "should,"
"target," "would," and similar expressions, constitute
forward-looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995. Actual results may differ
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.
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