Summit Therapeutics plc Summit Therapeutics Launches Online Resource For Patients With C. Difficile Infection
January 07 2020 - 7:00AM
UK Regulatory
TIDMSUMM
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
https://www.globenewswire.com/Tracker?data=H3o-7345yUftArfiSpcy2yCxNY2YRFZx4yAKaHegSsJwrkjo3ahHpNi_vI85FRAJGXBhtFqWP64uZH7k7_P8Fw==
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
https://www.globenewswire.com/Tracker?data=H3o-7345yUftArfiSpcy23mXaStfwvmoP8F8CEbHBwFY66dETrNuKyUbhBz9jDeuBPMIdGAD755fmd8w_yUSLA==
www.ricodify.com.
About Ridinilazole
Ridinilazole 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 Infection
C. 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
Glyn Edwards / Richard Pye (UK office) Tel: 44 (0)1235 443 951
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 / George Tzimas, Corporate
Finance
Tom Salvesen, Corporate Broking
Bryan Garnier & Co Limited (Joint Broker) Tel: +44 (0)20 7332 2500
Phil Walker / Dominic Wilson
MSL Group (US) Tel: +1 781 684 6652
mailto:summit@mslgroup.com
Erin Anthoine summit@mslgroup.com
---------------------------------
Consilium Strategic Communications (UK) Tel: +44 (0)20 3709 5700
Mary-Jane Elliott / Sue Stuart / Sukaina mailto:summit@consilium-comms.com
Virji summit@consilium-comms.com
---------------------------------
Lindsey Neville
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-
(END) Dow Jones Newswires
January 07, 2020 07:00 ET (12:00 GMT)
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