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Summit Therapeutics Announces Publication of Preclinical Data Showing Ridinilazole Outperformed Standard of Care in Reducing C. Difficile Toxins That Drive Disease Symptoms

OXFORD, United Kingdom, Feb. 24, 2016 (GLOBE NEWSWIRE) -- Summit Therapeutics plc (NASDAQ:SMMT) (AIM:SUMM), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy and Clostridium difficile infection (‘CDI’), announces the online publication of preclinical data in the Journal of Antimicrobial Chemotherapy supporting ridinilazole as a novel and potent antibiotic against CDI. The peer-reviewed paper reports ridinilazole outperformed the current standards of care, vancomycin and metronidazole, in preclinical studies by having a robust killing effect on C. difficile that significantly reduced the level of toxins produced by the bacteria that play a major role in driving the symptoms and severity of the disease. The study, funded by Summit, was conducted as part of a collaboration with researchers at the University of Houston College of Pharmacy.

“Ridinilazole is truly a differentiated antibiotic, driven by its exquisite selectivity and potency against C. difficile in preclinical studies, with the potential to treat CDI and reduce recurrent disease,” commented Kevin W. Garey, PharmD, MS, FASHP, Chair, Department of Pharmacy Practice and Translational Research Professor of Pharmacy Practice at the University of Houston College of Pharmacy and Principal Investigator in the study. “The data presented in this paper highlight some of ridinilazole’s potential advantages over the current standard of care antibiotics for CDI in the key virulence factor, toxin production. Based on all of the preclinical and recent positive Phase 2 clinical data, I believe ridinilazole has a promising future in the treatment of CDI.”

The research was published in the paper entitled, “Impact on toxin production and cell morphology in Clostridium difficile by ridinilazole (SMT19969), a novel treatment for C. difficile infection.” Progression of CDI most commonly involves production of toxin A and B by C. difficile to elicit an inflammatory response, including IL-8 release, which results in symptoms of disease including severe diarrhoea. In the study, in vitro treatment of C. difficile isolates with ridinilazole resulted in a significant reduction in toxin A and B levels and subsequent IL-8 release. These data were in contrast to treatment with vancomycin and metronidazole that were both comparable to control. Insights into the mechanism of ridinilazole revealed that it halts cell division, characterised by a significant increase in the length of C. difficile cells and an absence of division septum formation.

This publication is in addition to other recent peer-reviewed literature publications, which in aggregate bolster the preclinical data that highlight ridinilazole’s potential advantages over the current standard of care antibiotics for CDI. Links to the Journal of Antimicrobial Chemotherapy paper, along with the other publications, are available from the programmes section of the Summit website.

About C. difficile Infection
C. difficile infection is a serious healthcare threat in hospitals, long-term care homes and increasingly the wider community with between 450,000 and 700,000 cases of CDI in the US annually. It is caused by an infection of the colon by the bacterium C. difficile, which produces toxins that cause inflammation, 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. Existing CDI treatments are predominantly broad spectrum antibiotics, and these cause further damage to the gut flora and are associated with high rates of recurrent disease. Recurrent disease is the key clinical issue 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 (SMT19969) is an orally administered small molecule antibiotic that Summit is developing specifically for the treatment of CDI. In preclinical efficacy studies, ridinilazole exhibited a narrow spectrum of activity and had a potent bactericidal effect against all clinical isolates of C. difficile tested. 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 this 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 has received Qualified Infectious Disease Product (‘QIDP’) designation and has been granted Fast Track status by the US Food and Drug Administration. The QIDP incentives are provided through the US GAIN Act and include an extension of marketing exclusivity for an additional five years upon FDA approval.

About Summit Therapeutics
Summit is a biopharmaceutical company focused on the discovery, development and commercialisation of novel medicines for indications for which there are no existing or only inadequate therapies. Summit is conducting clinical programmes focused on the genetic disease Duchenne muscular dystrophy and the infectious disease C. difficile infection. Further information is available at www.summitplc.com and Summit can be followed on Twitter (@summitplc).

For more information, please contact:

Summit
Glyn Edwards / Richard Pye (UK office)
Erik Ostrowski / Michelle Avery (US office)

Tel: +44 (0)1235 443 951
+1 617 225 4455
Cairn Financial Advisers LLP
(Nominated Adviser)
Liam Murray / Tony Rawlinson


Tel: +44 (0)20 77148 7900
N+1 Singer
(Broker)
Aubrey Powell / Jen Boorer


Tel: +44 (0)20 7496 3000
Peckwater PR
(Financial public relations, UK)
Tarquin Edwards

Tel: +44 (0)7879 458 364
tarquin.edwards@peckwaterpr.co.uk
MacDougall Biomedical Communications
(US media contact)
Chris Erdman

Tel: +1 781 235 3060
cerdman@macbiocom.com

Forward-looking Statements
Any statements in this press release about Summit’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of Summit’s product candidates, the therapeutic potential of Summit’s product candidates, and the timing of initiation, completion and availability of data from clinical trials, 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 on-going 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, availability of funding sufficient for Summit’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the "Risk Factors" section of filings that Summit makes with the Securities and Exchange Commission including Summit’s Annual Report on Form 20-F for the fiscal year ended January 31, 2015. 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 Summit’s views only as of the date of this release and should not be relied upon as representing Summit’s views as of any subsequent date. Summit specifically disclaims any obligation to update any forward-looking statements included in this press release.

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Source:Summit Therapeutics PLC