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Summit’s DDS-04 Enterobacteriaceae Programme Demonstrates In Vivo Efficacy in Sepsis and Pneumonia

9 Jul 2019 12:00



Summit’s DDS-04 Enterobacteriaceae Programme Demonstrates In Vivo Efficacy in Sepsis and Pneumonia

Summit Therapeutics plc (‘Summit’ or the ‘Company’)

Summit’s DDS-04 Enterobacteriaceae Programme Demonstrates In Vivo Efficacy in Sepsis and Pneumonia

Proof of Concept Now Established in Animal Models Across Key Enterobacteriaceae IndicationsPathogen-Targeted Approach Seeks to Preserve Patients’ Microbiomes

Oxford, UK, and Cambridge, MA, US, 9 July 2019 – Summit Therapeutics plc (NASDAQ: SMMT, AIM: SUMM) today announces that it has demonstrated the potential of its DDS-04 series of new class antibiotics as an Enterobacteriaceae-targeted treatment through in vivo proof of concept data in sepsis and pneumonia animal models. These data build on the previously published proof of concept preclinical study for DDS-04 in urinary tract infections. Enterobacteriaceae are a family of Gram-negative bacteria that cause severe and often deadly infections.

“There is a great need to advance truly differentiated treatments for Gram-negative bacteria, where there have been no new classes of antibiotics discovered since the last century. In particular, the rise of untreatable and hard to treat Enterobacteriaceae infections is a frightening prospect,” said Dr David Roblin, President of R&D of Summit. “Our potential solution is DDS-04, a series of Enterobacteriaceae-targeted antibiotics for the treatment of resistant and non-resistant bacteria.”

In the sepsis infection model, mice were infected with E. coli. Intravenous treatment with a representative compound of the DDS-04 series cured the infection. For the pneumonia infection model, mice were infected with K. pneumoniae. Intravenous treatment with a representative compound of the DDS-04 series resulted in a significant reduction in bacterial burden in the lungs. Summit’s preclinical data indicate that DDS-04 compounds have the potential to treat Enterobacteriaceae infections in all three key infection sites of urinary tract, bloodstream and lung. However, it is the latter two where there is the greatest unmet patient need. Further details are expected to be published at an upcoming scientific meeting.

Dr Roblin added, “DDS-04 aligns with our strategy of targeting pathogenic bacteria and seeking to preserve patients’ good bacteria known to play an important role in overall patient health. Importantly, pathogen-targeted antibiotics could be a new front-line treatment to support good stewardship with broad-spectrum antibiotics being reserved.”

Today, Enterobacteriaceae infections are treated with a range of broad-spectrum antibiotics, where there is a high risk of treatment failure due to antibiotic resistance. Further, multi-drug resistance occurs in many of the severe hospital-acquired Enterobacteriaceae infections. Patients who receive multiple rounds of broad-spectrum antibiotics to treat these infections have increased risk for added complications, including C. difficile infection. A targeted, new class of antibiotics could have the benefit of not only being able to kill all strains of Enterobacteriaceae, regardless of resistance, but also could have the potential to preserve patients’ microbiomes.

The DDS-04 series is undergoing lead optimisation.

About DDS-04The DDS-04 series are 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 also showed low propensity for resistance development and did not show cross-resistance with existing classes of antibiotics, suggesting that DDS-04 compounds have 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 EnterobacteriaceaeEnterobacteriaceae 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) +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 FinanceTom 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
Jon Siegal summit@mslgroup.com
   
Consilium Strategic Communications (UK)Tel:+44 (0)20 3709 5700
Mary-Jane Elliott / Sue Stuart / Sukaina 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-


Date   Source Headline
3rd Apr 201912:00 pmGNWSummit’s Pipeline Expands with Series of New Mechanism Antibiotics Targeting Enterobacteriaceae
2nd Apr 201912:00 pmGNWSummit Therapeutics to Present at H. C. Wainwright & Co. Global Life Sciences Conference
29th Mar 20195:45 pmGNWAward of Share Options
29th Mar 201911:15 amGNWFiling of Annual Report on Form 20-F
27th Mar 201911:00 amGNWFinal Results
25th Mar 201911:00 amGNWNotice of Results
18th Mar 201911:00 amGNWSummit Therapeutics to Present at Upcoming Conferences
14th Mar 201911:00 amGNWSummit Highlights Use of Discuva Platform in Identifying New Mechanism Antibiotics against Neisseria Gonorrhoeae and ESKAPE Pathogens at Novel Antimicrobials and AMR Diagnostics 2019 Conference
25th Feb 201912:00 pmGNWSummit’s SMT-571 Potent Against Over 200 Clinical Isolates of Neisseria Gonorrhoeae, Including Numerous Multi- and Extensively-Drug Resistant Strains, in Published Preclinical Data
13th Feb 201912:00 pmGNWSummit Doses First Patient in Phase 3 Clinical Trials of Precision Antibiotic Ridinilazole for C. Difficile Infection
8th Feb 201912:00 pmGNWSummit Therapeutics to Present at the BIO CEO & Investor Conference
15th Jan 20195:45 pmGNWHolding(s) in Company
14th Jan 201912:00 pmGNWAward of Restricted Stock Units
10th Jan 20194:15 pmGNWHolding(s) in Company
10th Jan 201911:30 amGNWHolding(s) in Company
10th Jan 20197:00 amGNWCompletion of $25 million Subscription
9th Jan 20194:45 pmGNWHolding(s) in Company
8th Jan 20197:00 amGNWUpdate on Admission
4th Jan 201912:30 pmGNWResult of General Meeting
2nd Jan 20199:40 amGNWHolding(s) in Company
18th Dec 201812:15 pmGNWHolding(s) in Company
17th Dec 20187:05 amGNWProposed Subscription to Raise $25m and Notice of General Meeting
17th Dec 20187:00 amGNWSummit Therapeutics Announces Departure of Chief Financial Officer
11th Dec 201812:00 pmGNW3rd Quarter Results
6th Dec 201812:00 pmGNWSummit Therapeutics to Report Financial Results for the Third Quarter and Nine Months Ended 31 October 2018 on 11 December 2018
30th Nov 20181:30 pmGNWHolding(s) in Company
12th Nov 201812:00 pmGNWSummit Highlights Importance of Innovation in Fight Against Antibiotic Resistance During Antibiotics Awareness Week
12th Nov 20187:00 amGNWAppointment of Joint Broker
7th Nov 201812:00 pmGNWSummit Therapeutics to Participate in Jefferies 2018 London Healthcare Conference
1st Nov 20184:34 pmGNWHolding(s) in Company
1st Nov 201811:00 amGNWSummit Recognises C. difficile Awareness Month
24th Oct 20184:15 pmGNWDirector/PDMR Shareholding
22nd Oct 20187:00 amGNWAward of Share Options
20th Sep 201812:00 pmGNWSummit Reports Financial Results for the Second Quarter Ended 31 July 2018 and Operational Progress
27th Dec 20177:00 amRNSAcquisition of Discuva Ltd
10th May 20122:04 pmRNSGrant of Options
30th Dec 200911:07 amRNSResult of GM
30th Dec 20097:00 amRNSResult of Placing and Open Offer
11th Dec 200912:53 pmRNSPlacing and Open Offer and Appointment of NOMAD
11th Dec 200912:40 pmRNSWellcome Trust Grant
31st Jan 20087:00 amRNSTrading Statement
16th Jan 20087:01 amRNSStart of Ph II clinical trial
6th Dec 20077:00 amRNSChange of Adviser
5th Nov 200711:18 amRNSDirector/PDMR Shareholding
30th Oct 20077:02 amRNSRe Agreement
30th Oct 20077:01 amRNSInterim Results
25th Oct 20074:07 pmRNSHolding in Company
23rd Oct 20077:02 amRNSClinical Update
12th Oct 20079:00 amRNSNotice of Results
2nd Oct 20077:01 amRNSResearch Donation

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