SUMM Summit Therapeutics Plc

 
TIDMSUMM 
 
   Summit Therapeutics plc 
 
   ('Summit' or the 'Company') 
 
   Summit Therapeutics Recognises C. difficile Awareness Month 
 
 
   -- Company to Highlight Potential of Phase 3 Precision Antibiotic 
      Ridinilazole at the 7th Annual C. diff. Conference and Health EXPO 
 
 
   Oxford, UK, and Cambridge, MA, US, 4 November 2019 -- Summit 
Therapeutics plc (NASDAQ: SMMT, AIM: SUMM) recognises C. difficile 
Awareness Month. Each year, more than one million patients in the US and 
Europe are diagnosed with C. difficile infection ('CDI'), and yet 
general awareness of CDI is lacking. 
 
   "C. difficile is a common, yet largely unknown infection and its 
Awareness Month provides an opportunity to educate on this illness and 
bring the focus to the unacceptably high numbers of patients that 
current CDI treatments fail. The treatment failures are driven by the 
negative impact of current antibiotic treatments on the healthy bacteria 
of the gut microbiome," commented Dr David Roblin, President of R&D of 
Summit. "By being targeted to C. difficile, our precision antibiotic 
ridinilazole has the potential to preserve patients' microbiomes and 
improve outcomes for patients with CDI." 
 
   As part of its activities for CDI awareness month, Summit will be 
presenting at the 7(th) Annual C. diff. Conference and Health EXPO in 
St. Louis, Missouri. The presentation will review data from the Phase 2 
clinical trial of ridinilazole compared to vancomycin. In this clinical 
trial, ridinilazole achieved statistical superiority over vancomycin in 
the measure of sustained clinical response ('SCR'), which captured 
whether patients were cured of CDI and remained cured for 30 days after 
treatment. In addition, an exploratory endpoint in the trial showed 
patients treated with ridinilazole had significantly preserved gut 
microbiomes compared to vancomycin. 
 
   Ridinilazole is currently being evaluated in two global Phase 3 clinical 
trials for superiority over vancomycin in SCR. Data are expected from 
the trials in the second half of 2021. 
 
   For more information on CDI, visit the Peggy Lillis Foundation at 
https://www.globenewswire.com/Tracker?data=w6CxG950MmrmUWac6onN4H-fF061UPN6ubrE9Gf0mdtONXPBNTrlM2Sv2UYB797EGdpbqD9iubf-IEOKQoEPQD40uc7ZdGDO2-CdoJT-64U= 
www.peggyfoundation.org and 
https://www.globenewswire.com/Tracker?data=w6CxG950MmrmUWac6onN4G6LuFOGQvmD84L-UoS_Qznzq1J8PFXLOs4HX-RtLkxCUt4-gnnKja5qMUFc-KqJlQ== 
www.cdiff.org, and the C. diff Foundation at 
https://www.globenewswire.com/Tracker?data=w6CxG950MmrmUWac6onN4I98OGNOI8-LKdrKfqlhYulGtzT-q7vRap4f1j4c-xIEqe-GJ9u67oV5QFbnj7z3eYTuoigFFH4aF_0fm2njzu0= 
www.cdifffoundation.org. 
 
   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 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. 
 
   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. 
 
   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

November 04, 2019 07:00 ET (12:00 GMT)

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