Summit Therapeutics plc Summit Presented In Vivo Proof Of Concept Data For Targeted Enterobacteriaceae Antibiotics At Asm/Esc...

 
TIDMSUMM 
 
   Summit Therapeutics plc 
 
   ('Summit' or the 'Company') 
 
   Summit Presents In Vivo Proof of Concept Data for Targeted 
Enterobacteriaceae Antibiotic at ASM/ESCMID Conference 
 
 
   -- New Mechanism Antibiotic has Potential to Overcome Known Resistance 
      Mechanisms 
 
 
   Oxford, UK, and Cambridge, MA, US, 5 September 2019 -- Summit 
Therapeutics plc (NASDAQ: SMMT, AIM: SUMM) presented in vivo proof of 
concept data for its targeted Enterobacteriaceae antibiotics in animal 
models of sepsis, pneumonia and urinary tract infection ('UTI'). 
Efficacy data of Summit's DDS-04 series of antibiotics was comparable to 
marketed antibiotics in all three disease models. These data were 
presented in a poster session at the ASM/ESCMID Conference on Drug 
Development to Meet the Challenge of Antimicrobial Resistance held in 
Boston, MA, September 3-6, 2019. The findings build on previously 
reported in vitro studies that showed this new antibiotic class had high 
potency and specificity for multiple resistant and non-resistant 
Enterobacteriaceae strains. 
 
   "Currently marketed broad-spectrum antibiotics for Enterobacteriaceae 
infections are failing patients at an increasingly alarming rate due to 
rising antibiotic resistance," said Dr David Roblin, President of R&D of 
Summit. "Our DDS-04 series works via a new mechanism which has the 
potential to successfully cure patients by overcoming all known 
bacterial resistance mechanisms. The data presented at ASM/ESCMID show 
the promise of our DDS-04 series in combatting Enterobacteriaceae 
infections that we estimate cause more than one million infections 
annually in the US alone." 
 
   Increasing resistance has rendered many marketed antibiotics ineffective 
against Enterobacteriaceae. Two Enterobacteriaceae resistance trends 
seen in the clinic are on the US Centers for Disease Control and 
Prevention's list of urgent and serious bacterial threats. Against the 
backdrop of increasing resistance to current antibiotics, there is a 
clear need for the development of a new class of antibiotics that could 
overcome all known resistance liabilities. 
 
   Dr Roblin added, "We designed our DDS-04 series of new class antibiotics 
with the aim of treating infections at all sites where resistance is a 
clinical issue. That way, we have the chance to make the greatest 
positive impact on patients. We are extremely excited by the initial 
proof of concept data our DDS-04 series has shown across sepsis, 
pneumonia and UTI, and the prospect of moving this series forward." 
 
   The DDS-04 series is undergoing lead optimisation. 
 
   Details from the poster presentation: 
 
   Sepsis Model 
 
 
   -- Non-neutropenic mouse model (CD-1 mice) infected with E. coli 
 
   -- Mice dosed intravenously with DDS-04 series representative three times 
      once every three hours, starting one hour post-infection 
 
   -- Tigecycline used as reference, dosed 40mg/kg, two times, once at each of 
      one and six hours post-infection 
 
   -- After nine hours, bacterial burden was below the limit of detection in 
      the blood, kidneys, liver, lungs and spleen for both the DDS-04 compound 
      and tigecycline 
 
 
   Pneumonia Model 
 
 
   -- CD-1 mice infected with K. pneumoniae 
 
   -- Mice dosed intravenously with DDS-04 series representative three times, 
      once every eight hours, starting two hours post-infection 
 
   -- Tigecycline used as reference, dosed 40mg/kg, three times daily every 
      eight hours subcutaneously 
 
   -- After 26 hours, a 4.5 log10 reduction in bacterial burden was observed in 
      the lungs for the DDS-04 compound and a similar reduction was observed 
      with tigecycline 
 
 
   UTI Model 
 
 
   -- C3H/HeN female mice were infected with E. coli 
 
   -- Mice dosed intravenously with DDS-04 series representative three times 
      daily every eight hours over three days 
 
   -- Ciprofloxacin used as reference, dosed 10mg/kg, three times daily every 
      eight hours over three days 
 
   -- On day four, a significant reduction in bacterial burden was observed in 
      the urine, bladder and kidneys for both the DDS-04 compound and 
      ciprofloxacin 
 
   About DDS-04 
 
   The DDS-04 series comprises targeted-spectrum compounds that act via a 
novel bacterial target, LolCDE. With its new mechanism of action, the 
DDS-04 series was rapidly bactericidal and highly potent across globally 
diverse Enterobacteriaceae strains in research studies, which included 
multi-drug resistant isolates. Importantly, the DDS-04 series has also 
shown a low propensity for resistance development and did not show 
cross-resistance with existing classes of antibiotics, suggesting the 
DDS-04 series has the potential to overcome known resistance mechanisms. 
This profile makes the DDS-04 series attractive for further development 
for the treatment of Enterobacteriaceae infections. 
 
   About Enterobacteriaceae 
 
   Enterobacteriaceae are a family of Gram-negative bacteria responsible 
for severe and often deadly infections. They account for a significant 
fraction of cases across conditions, including bloodstream infections, 
hospital-acquired pneumonias and complicated urinary tract infections. 
Summit estimates there are more than 1 million infections in the US 
annually caused by Enterobacteriaceae across these three settings. 
Increasing resistance of Enterobacteriaceae has rendered many marketed 
antibiotics ineffective against these bacteria. Two of the most alarming 
antibiotic resistance trends are extended-spectrum beta-lactamase 
(ESBL)-producing Enterobacteriaceae and carbapenem-resistant 
Enterobacteriaceae (CRE). ESBL is an enzyme that allows bacteria to 
become resistant to a wide variety of penicillin and cephalosporin 
antibiotics. CRE are resistant to nearly all existing antibiotics, 
including carbapenems which are considered the antibiotics of last 
resort. 
 
   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. 
 
   Contacts 
 
 
 
 
Summit 
Glyn Edwards / Richard Pye (UK office)     Tel:                  44 (0)1235 443 951 
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 
 
Bryan Garnier & Co Limited (Joint Broker)  Tel:                 [phone] 
Phil Walker / Dominic Wilson 
MSL Group (US)                             Tel:                     [phone] 
                                                         mailto:[e-mail] 
Jon Siegal                                                      [e-mail] 
                                                  --------------------------------- 
 
Consilium Strategic Communications (UK)    Tel:                 [phone] 
Mary-Jane Elliott / Sue Stuart / Sukaina          mailto:[e-mail] 
 Virji /                                           [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 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

September 05, 2019 07:00 ET (11:00 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.