Summit Therapeutics Recognises C. difficile Awareness Month
04 November 2019 - 11:00PM
Summit Therapeutics plc (‘Summit’ or the
‘Company’)
Summit Therapeutics Recognises C. difficile Awareness
Month
- Company to Highlight Potential of Phase 3 Precision
Antibiotic Ridinilazole at the 7th Annual C. diff. Conference and
Health EXPO
Oxford, UK, and Cambridge, MA, US, 4 November
2019 – Summit Therapeutics plc (NASDAQ: SMMT, AIM:
SUMM) recognises C. difficile Awareness Month. Each year,
more than one million patients in the US and Europe are diagnosed
with C. difficile infection (‘CDI’), and yet general awareness of
CDI is lacking.
“C. difficile is a common, yet largely unknown
infection and its Awareness Month provides an opportunity to
educate on this illness and bring the focus to the unacceptably
high numbers of patients that current CDI treatments fail. The
treatment failures are driven by the negative impact of current
antibiotic treatments on the healthy bacteria of the gut
microbiome,” commented Dr David Roblin, President of R&D of
Summit. “By being targeted to C. difficile, our precision
antibiotic ridinilazole has the potential to preserve patients’
microbiomes and improve outcomes for patients with CDI.”
As part of its activities for CDI awareness
month, Summit will be presenting at the 7th Annual C. diff.
Conference and Health EXPO in St. Louis, Missouri. The presentation
will review data from the Phase 2 clinical trial of ridinilazole
compared to vancomycin. In this clinical trial, ridinilazole
achieved statistical superiority over vancomycin in the measure of
sustained clinical response (‘SCR’), which captured whether
patients were cured of CDI and remained cured for 30 days after
treatment. In addition, an exploratory endpoint in the trial showed
patients treated with ridinilazole had significantly preserved gut
microbiomes compared to vancomycin.
Ridinilazole is currently being evaluated in two
global Phase 3 clinical trials for superiority over vancomycin in
SCR. Data are expected from the trials in the second half of
2021.
For more information on CDI, visit the Peggy
Lillis Foundation at www.peggyfoundation.org and www.cdiff.org, and
the C. diff Foundation at www.cdifffoundation.org.
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. The vast
majority of patients are treated with 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. A study estimated that the total costs
attributable to the management of CDI were approximately $6.3
billion per year in the United States.
About RidinilazoleRidinilazole is an oral
small molecule new mechanism antibiotic that is designed to
selectively kill C. difficile, thereby preserving patients’
protective gut microbiome and leading to sustained CDI cures. In a
Phase 2 proof of concept trial in CDI patients, ridinilazole showed
statistical superiority in sustained clinical response ('SCR')
rates compared to 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 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.
The clinical and regulatory development of
ridinilazole is being funded in part with Federal funds from the US
Department of Health and Human Services, Office of the Assistant
Secretary for Preparedness and Response, Biomedical Advanced
Research and Development Authority (‘BARDA’), under Contract No.
HHS0100201700014C.
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 infections caused by C. difficile, N. gonorrhoeae
and Enterobacteriaceae 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 |
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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N+1 Singer (Joint Broker) |
Tel: |
+44 (0)20 7496 3000 |
Aubrey Powell / Jen Boorer, Corporate FinanceTom Salvesen,
Corporate Broking |
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Bryan Garnier & Co Limited (Joint Broker) |
Tel: |
+44 (0)20 7332 2500 |
Phil Walker / Dominic Wilson |
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MSL Group (US) |
Tel: |
+1 781 684 6652 |
Erin Anthoine |
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summit@mslgroup.com |
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Consilium Strategic Communications (UK) |
Tel: |
+44 (0)20 3709 5700 |
Mary-Jane Elliott / Sue Stuart / Sukaina Virji |
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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 2019. 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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