Summit Therapeutics Announces Publication of Preclinical Data Showing Ridinilazole Outperformed Standard of Care in Reducing ...
March 09 2016 - 6:46PM
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 InfectionC.
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 RidinilazoleRidinilazole
(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) |
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Tel: +44
(0)1235 443 951 +1 617 225 4455 |
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Cairn Financial Advisers LLP(Nominated
Adviser)Liam Murray / Tony Rawlinson |
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Tel: +44 (0)20 77148 7900 |
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N+1 Singer (Broker)Aubrey Powell / Jen Boorer |
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Tel: +44 (0)20 7496 3000 |
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Peckwater PR(Financial public relations,
UK)Tarquin Edwards |
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Tel: +44
(0)7879 458 364 tarquin.edwards@peckwaterpr.co.uk |
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MacDougall Biomedical Communications(US media
contact)Chris Erdman |
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Tel: +1
781 235 3060cerdman@macbiocom.com |
Forward-looking StatementsAny 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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