Summit Therapeutics plc Summit Therapeutics Plc: Phase 2 Codify Trial Results Published In Lancet Infectious Diseases

 
TIDMSUMM 
 
 
   Summit Therapeutics plc 
 
   ('Summit', or the 'Company') 
 
   PHASE 2 CoDIFy TRIAL RESULTS PUBLISHED IN LANCET INFECTIOUS DISEASES 
WITH DATA SHOWING SUMMIT'S RIDINILAZOLE ACHIEVED STATISTICAL SUPERIORITY 
OVER VANCOMYCIN IN THE TREATMENT OF C. DIFFICILE INFECTION 
 
   Oxford, UK, 2 May 2017 - Summit Therapeutics plc (AIM: SUMM, NASDAQ: 
SMMT), the drug discovery and development company advancing therapies 
for Duchenne muscular dystrophy and C. difficile infection ('CDI'), 
announces the online publication of results from the Company's Phase 2 
clinical trial, called CoDIFy, in The Lancet Infectious Diseases. CoDIFy 
evaluated the Company's novel antibiotic for the treatment of CDI, 
ridinilazole, against standard of care, vancomycin. The results showed 
ridinilazole demonstrated substantial clinical benefit over vancomycin. 
This included ridinilazole achieving statistical superiority over 
vancomycin in sustained clinical response ('SCR'), a composite endpoint 
of cure at the end of treatment and no recurrence 30 days after 
treatment, a result which was driven by a large numerical reduction in 
infection recurrence. 
 
   "CDI is a serious disease that is a major healthcare challenge due to 
the high recurrence rates which are believed to be exacerbated by the 
broad spectrum antibiotics we use to treat CDI today," Professor Mark 
Wilcox, University of Leeds and Principal Investigator in CoDIFy 
commented. "A highly selective antibiotic has the potential to transform 
the current treatment paradigm and keep recurrent CDI at bay. The 
ability of ridinilazole to provide a significant increase in sustained 
clinical responses compared with the standard of care in CoDIFy provides 
evidence that ridinilazole is highly selective and warrants its 
continued clinical development." 
 
   Key results from CoDIFy published in The Lancet Infectious Diseases: 
 
 
   -- Ridinilazole achieved statistical superiority in sustained clinical 
      response ('SCR') with rates of 66.7% compared with 42.4% for vancomycin. 
 
   -- Ridinilazole achieved a large numerical reduction in recurrent disease 
      over vancomycin (14.3% recurrence with ridinilazole vs. 34.8% recurrence 
      with vancomycin). 
 
   -- Ridinilazole met the pre-specified endpoint of non-inferiority on cure 
      rates at the end of treatment (77.8% for ridinilazole vs. 69.7% for 
      vancomycin). 
 
   -- Median time to resolution of diarrhoea favoured ridinilazole (four days 
      on ridinilazole vs. five days on vancomycin) and numerically more 
      subjects on ridinilazole had resolution of diarrhoea compared with 
      vancomycin by day six (77.8% vs. 63.6%). 
 
   -- Median time to hospital discharge was five days for ridinilazole-treated 
      subjects versus seven days for vancomycin-treated subjects. 
 
   -- Ridinilazole was retained in the gut, the site of infection, with 
      negligible systemic exposure observed. 
 
   -- Adverse event profiles were similar between ridinilazole-treated and 
      vancomycin-treated subjects, with no safety signals being identified with 
      ridinilazole. 
 
 
   Mr Glyn Edwards, Chief Executive Officer of Summit, added: "The results 
of our CoDIFy trial provided further evidence of ridinilazole's ability 
to address the key clinical issue of recurrence, which could lead to 
improved patient care and reduced economic burden of CDI. We are 
therefore planning to progress this novel programme into Phase 3 
clinical trials. With ridinilazole, we believe we have a promising 
potential treatment option for this potentially fatal infectious 
disease." 
 
   Ridinilazole is now being prepared for entry into a Phase 3 clinical 
programme that is expected to comprise two Phase 3 trials evaluating 
ridinilazole compared to vancomycin. The primary endpoint of the Phase 3 
clinical trials is expected to be testing for superiority on sustained 
clinical response. The Phase 3 clinical trials are planned to start in 
the first half of 2018. 
 
   The publication reference is Lancet Infect Dis 2017; published online 
Apr 28: 
http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(17)30235-9/fulltext?elsca1=tlxpr. 
 
 
   About CoDIFy 
 
   CoDIFy was a double blind, randomized, active controlled, multi-centre, 
Phase 2 clinical trial that evaluated the efficacy of ridinilazole 
against vancomycin in a total of 100 patients. Half of the patients 
received ridinilazole for ten days (200 mg, twice a day), and the 
remaining half received vancomycin for ten days (125 mg, four times a 
day). In addition to the results described above, ridinilazole was found 
to be highly preserving of the gut microbiome. Ridinilazole treated 
patients in CoDIFy exhibited no further damage to their microbiome 
during therapy with a proportion of patients showing initial evidence of 
recovery of key bacterial groups with roles in protecting from CDI. In 
contrast, vancomycin treated patients suffered substantial damage to 
their gut microbiome during treatment and this persisted in many 
patients during the 30-day post treatment period. 
 
   About C. difficile Infection 
 
   C. difficile infection is a serious healthcare threat in hospitals, 
long-term care homes and increasingly the wider community with over one 
million estimated cases of CDI each year in the United States and 
Europe. It 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, and these cause 
further damage to the gut flora and are associated with high rates of 
recurrent disease. Recurrent disease is the key clinical issue 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 an orally administered small molecule antibiotic that 
Summit is developing specifically for the treatment of CDI. In 
preclinical efficacy studies, ridinilazole exhibited a narrow spectrum 
of activity and had a potent bactericidal effect against all clinical 
isolates of C. difficile tested. 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 this 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 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 an extension of marketing exclusivity for an 
additional five years upon FDA approval. 
 
   About Summit Therapeutics 
 
   Summit is a biopharmaceutical company focused on the discovery, 
development and commercialization of novel medicines for indications for 
which there are no existing or only inadequate therapies. Summit is 
conducting clinical programs focused on the genetic disease Duchenne 
muscular dystrophy and the infectious disease C. difficile infection. 
Further information is available at www.summitplc.com and Summit can be 
followed on Twitter (@summitplc https://twitter.com/Summitplc ). 
 
   For more information, please contact: 
 
 
 
 
Summit Therapeutics 
 Glyn Edwards / Richard Pye (UK office)         Tel: [phone] 
 Erik Ostrowski / Michelle Avery (US office)    [phone] 
Cairn Financial Advisers LLP 
 (Nominated Adviser)                            Tel: [phone] 
 Liam Murray / Tony Rawlinson 
N+1 Singer 
 (Broker)                                       Tel: [phone] 
 Aubrey Powell / Lauren Kettle 
MacDougall Biomedical Communications 
 (US media contact)                            Tel: [phone] 
 Chris Erdman / Karen Sharma                   [e-mail] [e-mail] 
Consilium Strategic Communications 
 (Financial public relations, UK)              Tel: [phone] 
 Mary-Jane Elliott / Sue Stuart /              [e-mail] 
 Jessica Hodgson / Lindsey Neville 
 
 
 
   Forward Looking Statements 
 
   Any statements in this press release about our future expectations, 
plans and prospects, including statements about development and 
potential commercialisation of our product candidates, the therapeutic 
potential of our product candidates, the timing of initiation, 
completion and availability of data from clinical trials, any other 
potential third-party collaborations and expectations regarding the 
sufficiency of our cash balance to fund operating expenses and capital 
expenditures, 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 will be 
indicative of the results of later clinical trials, expectations for 
regulatory approvals, availability of funding sufficient for our 

foreseeable and unforeseeable operating expenses and capital expenditure 
requirements and other factors discussed in the "Risk Factors" section 
of filings that we make with the Securities and Exchange Commission, 
including our Annual Report on Form 20-F for the fiscal year ended 31 
January 2017. In addition, any forward-looking statements included in 
this press release represent our views only as of the date of this 
release and should not be relied upon as representing our views as of 
any subsequent date. We specifically disclaim any obligation to update 
any forward-looking statements included in this press release. 
 
   - END - 
 
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contained therein. 
 
   Source: Summit Therapeutics plc via Globenewswire 
 
 
  http://www.summitplc.com/ 
 

(END) Dow Jones Newswires

May 02, 2017 02:00 ET (06:00 GMT)

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