SUMM Summit Therapeutics Plc

 
TIDMSUMM 
 
   Summit Therapeutics plc 
 
   ('Summit' or the 'Company') 
 
   Summit Doses First Patient in Phase 3 Clinical Trials of Precision 
Antibiotic Ridinilazole for C. Difficile Infection 
 
 
   -- Trials Aim to Show Superiority of Ridinilazole Over Standard of Care 
      Treatment Vancomycin 
 
   -- Health Economic Outcomes Included to Support Commercialisation 
 
 
   Oxford, UK, and Cambridge, MA, US, 13 February 2019 -- Summit 
Therapeutics plc (NASDAQ: SMMT, AIM: SUMM), a leader in new mechanism 
antibiotic innovation, today announces it has dosed the first patient in 
the global Phase 3 clinical trials of its precision oral antibiotic, 
ridinilazole, for C. difficile infection ('CDI'). The trials aim to show 
superiority of ridinilazole over the standard of care, vancomycin, in a 
measure that combines CDI cure and recurrence called sustained clinical 
response ('SCR'). Ridinilazole achieved statistical superiority over 
vancomycin in SCR in a Phase 2 clinical trial. 
 
   "Starting our Phase 3 programme is an important milestone for Summit," 
commented Mr Glyn Edwards, Chief Executive Officer of Summit. "With 
positive results, we believe ridinilazole could be positioned as the 
drug of choice in the front-line treatment of CDI, which potentially 
provides patients with sustained cures and hospitals with compelling 
cost savings." 
 
   "Ridinilazole is the trail-blazer in our growing pipeline of innovative 
product candidates targeting serious infectious diseases," added Dr 
David Roblin, President of R&D of Summit. "Our Phase 3 programme 
exemplifies our broader strategy of demonstrating significant advantages 
over current standards of care by gathering a carefully considered 
package of clinical and economic data to address the needs of physicians, 
regulators, healthcare providers, payors and, above all, patients." 
 
   The Phase 3 clinical programme comprises two global, randomised, 
double-blind, active-controlled clinical trials called Ri-CoDIFy 1 and 
Ri-CoDIFy 2. The trials will be run concurrently with each expected to 
enrol approximately 680 patients at sites in North America, Latin 
America, Europe, Australia and Asia. Upon confirmation of a positive CDI 
toxin test, patients will be randomised to receive either ridinilazole 
(200mg twice a day) or vancomycin (125mg four times a day) for ten days. 
The primary endpoint of both clinical trials will test for superiority 
in SCR, defined as cure at the end of treatment and no recurrence of CDI 
within 30 days post-treatment. Secondary endpoints include cure at the 
end of treatment and SCR at 60 days and 90 days post-treatment. 
Additional endpoints will evaluate the impact of ridinilazole and 
vancomycin on the gut microbiome, which is known to protect against CDI. 
The Phase 3 clinical trials also include health economic outcome 
measures, such as readmission rates and length of hospital stay, to help 
support the commercialisation of ridinilazole, if approved. 
 
   Top-line data from the Phase 3 programme are expected to be reported in 
the second half of 2021. 
 
   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. Summit is eligible to 
receive up to $62 million in funding from BARDA to support the clinical 
and regulatory development of ridinilazole. 
 
   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. 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 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 ESKAPE pathogens 
and are using our proprietary Discuva Platform to expand our pipeline. 
For more information, visit www.summitplc.com and follow us on Twitter 
@summitplc. 
 
   This announcement contains inside information for the purposes of 
Article 7 of EU Regulation 596/2014 (MAR). The person responsible for 
arranging the release of this announcement on behalf of the Company is 
Richard Pye, Senior Director, Corporate Affairs and Communications. 
 
   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 6557 
                                                         mailto:summit@mslgroup.com 
Jon Siegal                                                      summit@mslgroup.com 
                                                  --------------------------------- 
 
Consilium Strategic Communications (UK)    Tel:                 +44 (0)20 3709 5700 
Mary-Jane Elliott / Sue Stuart / Jessica          mailto:summit@consilium-comms.com 
 Hodgson /                                         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 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

February 13, 2019 07:00 ET (12:00 GMT)

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