SUMM Summit Therapeutics Plc

 
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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