Summit Therapeutics plc Summit Recognises C. Difficile Awareness Month

 
TIDMSUMM 
 
   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 6(th) 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 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. 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 Ridinilazole 
 
   Ridinilazole 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 
Glyn Edwards / Richard Pye (UK 
 office)                                Tel:                  44 (0)1235 443 951 
Erik Ostrowski / Michelle Avery 
 (US office)                                                     [phone] 
 
Cairn Financial Advisers LLP 
 (Nominated Adviser)                    Tel:                 [phone] 
Liam Murray / Tony Rawlinson 
 
N+1 Singer (Joint Broker)               Tel:                 [phone] 
Aubrey Powell / Jen Boorer, Corporate 
 Finance 
 Tom Salvesen, Corporate Broking 
 
Panmure Gordon (Joint Broker)           Tel:                 [phone] 
Freddy Crossley, Corporate Finance 
 James Stearns, Corporate Broking 
 
MSL Group (US)                          Tel:                     [phone] 
                                                      mailto:[e-mail] 
Jon Siegal                                                   [e-mail] 
                                               --------------------------------- 
 
Consilium Strategic Communications 
 (UK)                                   Tel:                 [phone] 
Mary-Jane Elliott / Jessica Hodgson            mailto:[e-mail] 
 / Sue Stuart /                                 [e-mail] 
                                               --------------------------------- 
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 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. 
 
   -END- 
 
 
 
 

(END) Dow Jones Newswires

November 01, 2018 07:00 ET (11:00 GMT)

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