Summit Therapeutics plc Summit Highlights Phase 3-Ready Precision Antibiotic Ridinilazole At Idweek 2018

 
TIDMSUMM 
 
   Summit Therapeutics plc 
 
   ('Summit' or the 'Company') 
 
   Summit Highlights Phase 3-Ready Precision Antibiotic Ridinilazole at 
IDWeek 2018 
 
 
   -- Ridinilazole in Development to Treat C. difficile Infection and Reduce 
      Recurrent Disease 
 
 
   Oxford, UK, and Cambridge, MA, US, 3 October 2018 -- Summit Therapeutics 
plc (NASDAQ: SMMT, AIM: SUMM), a leader in new mechanism antibiotic 
innovation, is highlighting ridinilazole's potential as a front-line 
treatment for C. difficile infection ('CDI') in a series of oral and 
poster presentations at the infectious disease conference IDWeek 2018 in 
San Francisco, CA. Ridinilazole is the Company's most advanced new 
mechanism antibiotic, which is expected to enter Phase 3 clinical trials 
in the first quarter of 2019. 
 
   As are being outlined at IDWeek, the Phase 3 clinical trials of 
ridinilazole are designed not only to evaluate ridinilazole in the 
treatment of CDI but also to show its impact on reducing disease 
recurrence and in preserving the gut microbiome, important determinants 
of public health impact. The effectiveness of ridinilazole in the 
treatment of CDI and CDI recurrence will be evaluated by measuring 
sustained clinical response ('SCR'), which is the primary endpoint for 
both of the two planned Phase 3 clinical trials. 
 
   "We believe that to have success in antibiotics, we need to be bold and 
think differently. This is highlighted by our Phase 3 clinical trial 
design for ridinilazole that aims to show superiority of ridinilazole 
over vancomycin, the current standard of care. The primary endpoint will 
measure how ridinilazole can treat CDI and reduce recurrent CDI, the 
major unmet need in this disease. Finally, we are incorporating health 
economic outcomes measures that we believe will help support premium 
pricing," commented Dr David Roblin, President of R&D of Summit. "If the 
Phase 3 clinical trial results are positive, we believe these measures 
would differentiate ridinilazole in CDI and support its front-line use." 
 
   A summary of the information being presented at IDWeek includes: 
 
 
   -- Ridinilazole achieving statistical superiority over vancomycin in the 
      primary endpoint of SCR in a Phase 2 clinical trial called CoDIFy; this 
      superiority was driven by a large reduction in CDI recurrence. 
 
   -- Ridinilazole significantly preserved the gut microbiome of patients with 
      CDI in CoDIFy, which Summit believes led to the reduction in recurrent 
      CDI. 
 
   -- The design of the ridinilazole Phase 3 clinical trials called Ri-CoDIFy 
      which will use the same primary endpoint of SCR. 
 
   -- Ridinilazole's activity is targeted to the site of infection. Preclinical 
      studies and Phase 1 and 2 clinical trials of ridinilazole have shown 
      negligible systemic exposure and levels of drug in the colon and/or 
      faeces significantly above the minimum inhibitory concentration. 
 
   -- A good safety profile with ridinilazole, being generally well tolerated 
      in prior clinical trials and non-clinical studies. 
 
   -- Ridinilazole was significantly more potent against over 500 recent 
      clinical isolates of C. difficile than vancomycin and metronidazole, 
      another commonly used CDI treatment, regardless of ribotype or antibiotic 
      resistance profile. 
 
   -- Diagnostics are important for selective antibiotics, such as ridinilazole, 
      to ensure patients are treated with the right drug for their infection. 
      As was used in CoDIFy, a test for the toxins produced by C. difficile 
      will also be used in the Phase 3 clinical trials to confirm that patients 
      have CDI. 
 
 
   Copies of the presentations are available under the Publications section 
of Summit's website, 
https://www.globenewswire.com/Tracker?data=dDhW-iqCY8MGLzkWz8QeIba3HMJ7ibk-lDuBlGyjONgwdb7P7YiUCGZ8hrOtGMbZuUUla6IG0CSNOrm4uFjnigCdjgv59vwdeJ0EfIKThKA= 
www.summitplc.com. 
 
   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:summit@consilium-comms. 
                                                       com 
                                                       [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

October 03, 2018 07:00 ET (11:00 GMT)

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