Summit Therapeutics plc Summit Therapeutics Reports Ridinilazole Significantly Improved Short And Longer-Term Quality Of Life...

 
TIDMSUMM 
 
   Summit Therapeutics plc 
 
   ('Summit' or the 'Company') 
 
   Summit Therapeutics Reports Ridinilazole Significantly Improved Short 
and Longer-Term Quality of Life Measures in Patients with C. difficile 
Infection Compared to Standard of Care 
 
 
   -- Statistically Significant Improvements in Physical and Mental Health 
      Measures 
 
   -- Benefit of Ridinilazole Treatment Seen as Early as Day Five 
 
   -- Data from Phase 2 Clinical Trial Presented at ID Week 2019 
 
 
   Oxford, UK, and Cambridge, MA, US, 3 October 2019 -- Summit Therapeutics 
plc (NASDAQ: SMMT, AIM: SUMM) today announced that it presented results 
from the Phase 2 clinical trial of ridinilazole in C. difficile 
infection ('CDI') detailing improvements in patient quality of life 
following antibiotic treatment for CDI. These results were presented in 
a poster session at ID Week 2019 being held in Washington, DC between 
2-6 October. 
 
   "CDI is debilitating for patients, both physically and mentally. Our 
Phase 2 clinical trial documented significant early and longer-term 
improvements in patient quality of life over the current standard of 
care," commented Dr David Roblin, President of R&D of Summit. "These 
findings suggest the benefits of treatment with ridinilazole goes beyond 
the clinical benefits seen in the Phase 2 clinical trial, with our 
precision antibiotic also improving the overall wellbeing of the 
patient." 
 
   The Phase 2 clinical trial called CoDIFy evaluated ridinilazole compared 
to vancomycin in 100 patients with CDI. As part of the trial, patients 
completed the EuroQol 5-Dimension questionnaire three level version 
(EQ-5D-3L) at baseline, day 5, 10, 12 (test of clinical cure at end of 
treatment) and 40 (test of sustained clinical response). The EQ-5D-3L is 
a standard measure of health status which evaluates five dimensions: 
mobility, self-care, usual activities, pain/discomfort and 
anxiety/depression. 
 
   "The patient is at the centre of our drug development universe. Global 
regulatory authorities and payors recognise that the value of treatments 
encompasses more than just clinical results and are placing increasing 
importance on patient reported outcomes, such as the EQ-5D index, in 
assessing new therapies," said Dr Daniel Elger, Chief Commercial 
Officer. "We are highly encouraged by the early and significant changes 
seen in the Phase 2 trial for patients on ridinilazole compared to the 
current standard of care, vancomycin, and look forward to the data from 
patient reported outcomes in our ongoing Phase 3 clinical trials of 
ridinilazole." 
 
   Overall, fewer patients treated with ridinilazole than patients treated 
with vancomycin reported any problems over the time points in four of 
the five domains: mobility, self-care, usual activities and 
pain/discomfort. Patients in both arms reported problems with anxiety 
and depression at baseline, however, the number of patients treated with 
ridinilazole reporting problems in this measure decreased throughout the 
timepoints. In contrast, the number of patients treated with vancomycin 
reporting problems with anxiety and depression increased at Day ten and 
remained high through the end of the study. By Day 40, patients treated 
with ridinilazole had improved significantly more than vancomycin in 
anxiety and depression. As early as Day five, patients treated with 
ridinilazole reported significant improvements in index scores (p=0.008), 
a measure which combines scores from the five domains, and visual 
analogue scale (VAS) scores (p=0.01), which is a self-reported score of 
overall health. While both treatment arms showed significant 
improvements in pain and discomfort with treatment, by Day ten, 
numerically fewer patients treated with ridinilazole reported issues 
than those treated with vancomycin. These results, along with the 
statistical superiority achieved in the primary clinical endpoint of 
sustained clinical response, support the continued development of 
ridinilazole. 
 
   A copy of the presentation is available in the Publications section of 
Summit's website, 
https://www.globenewswire.com/Tracker?data=GXaTsxjSkxrDi3AlyGlT3cnVkKy4n_25tGCufEhxZnhVALJ_B0Gi0CMjPNpnOBHvaOS0l_o9XZ3BCagG9K8w0ubnROsUfB3-aQv1LzyLEsI= 
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. 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 Ridinilazole 
 
   Ridinilazole is an oral small molecule new mechanism antibiotic that is 
designed to selectively kill C. difficile, thereby preserving patients' 
protective gut microbiome and leading to sustained CDI cures. 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 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 
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 / Jen Boorer, 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

October 03, 2019 07:00 ET (11:00 GMT)

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