Summit Therapeutics Launches Online Resource for Patients with C. difficile Infection
January 07 2020 - 6:00AM
Summit Therapeutics plc (‘Summit’ or the
‘Company’)
Summit Therapeutics Launches Online Resource for Patients
with C. difficile Infection
Oxford, UK, and Cambridge, MA, US, 7 January
2020 – Summit Therapeutics plc (NASDAQ: SMMT, AIM: SUMM) today
launched www.ricodify.com, an online resource for patients with C.
difficile infection (‘CDI’) and their caregivers. The site provides
information about CDI, the role of the microbiome in CDI and
Summit’s ongoing Phase 3 clinical trials of its investigational
precision antibiotic, ridinilazole.
“CDI is underserved by today’s available
treatments, making it an urgent public health threat,” commented
Mr Glyn Edwards, CEO of Summit. “With this online resource, we
hope to provide those diagnosed with CDI and their caregivers with
an understanding of factors pertinent to the choice of therapy, as
well as information about the opportunity to be involved in our
Ri-CoDIFy clinical trials evaluating ridinilazole for CDI.”
The Ri-CoDIFy clinical trials are expected to
enrol up to 1360 patients across sites in North America, South
America, Europe, Australia and Asia. Patients in the trial receive
either ridinilazole or vancomycin, an antibiotic currently used to
treat CDI, for ten days and are followed for a further 90 days to
assess various efficacy and safety measures. For more information,
visit www.ricodify.com.
About RidinilazoleRidinilazole is an
investigational oral small molecule new mechanism antibiotic that
is designed to selectively kill C. difficile, thereby preserving
patients’ protective gut microbiome. In a Phase 2 proof of concept
trial in CDI patients, ridinilazole showed statistical superiority
in sustained clinical response ('SCR') rates. 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. The gut microbiome is known to be important
in protecting against CDI. 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 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 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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|
|
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N+1 Singer (Joint Broker) |
Tel: |
+44 (0)20 7496 3000 |
Aubrey Powell / George Tzimas, Corporate FinanceTom Salvesen,
Corporate Broking |
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|
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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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|
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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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