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 new preclinical data on ridinilazole, a novel and highly
selective antibiotic for the treatment of CDI, were presented at
ASM Microbe 2017 that was held in New Orleans, US from 1-5 June
2017.
“These positive preclinical data presented at
ASM Microbe highlight the potency of ridinilazole against a wide
range of C. difficile clinical isolates from patients with CDI,”
commented Dr David Roblin, President of Research and
Development of Summit. “Combining potency and selectivity,
ridinilazole has shown positive results in clinical trials that
support its potential to treat patients with CDI and reduce the
rate of recurrent disease. It is thought that the preservation and
restoration of the patient microbiome is important in reducing
recurrence and ridinilazole’s narrow spectrum is designed to
achieve this. We believe ridinilazole has the potential to be a
novel, and urgently needed, front-line treatment option for this
serious disease.”
The results were detailed in two poster
presentations given by L.A. McDermott and E. Bassères,
respectively. Summaries of the presentations are as follows:
In-vitro Activity of Ridinilazole and
Comparators against Isolates of Clostridium difficile Obtained from
Stools of Patients as Part of US surveillance in 2014DR
Snydman, LA McDermott, CM Thorpe, J Chang, J Wick, SG Jenkins, EJC
Goldstein, R Patel, BA Forbes, S Johnson, D Gerding, ST Walk
and R VickersThis study, funded by Summit, assessed ridinilazole
against 200 clinical isolates of C. difficile collected from toxin
positive stool samples during 2014 as part of a US surveillance
programme. The results showed that ridinilazole was very active
against all C. difficile isolates with overall minimum inhibition
concentrations (MIC) distributed over a very narrow range of 0.12
to 0.5 µg/mL. Based on the MIC90 of 0.25 mg/mL, ridinilazole was
more potent than vancomycin and metronidazole, two antibiotics
commonly prescribed to treat CDI. Ridinilazole also maintained
activity against 027 hypervirulent strains of C. difficile and
retained activity against C. difficile isolates resistant to common
antibiotics moxifloxacin, clindamycin, vancomycin and imipenem.
In vitro Selection of Clostridium
difficile Resistance Mutants Exposed to RidinilazoleE.
Bassères, T. Rashid, B. Endres, M. Alam, R. Vickers, and KW.
GareyThis in vitro study, also funded by Summit, was designed to
understand the effects of ridinilazole on resistance development
and further elucidate the mechanism of action of this highly potent
yet selective antibiotic for the treatment of CDI. A low-level,
stable ridinilazole mutant resistant strain was developed after
multiple sub-MIC passages and this mutant will be used in future
preclinical studies on mechanism of action.
Copies of the presentations given at ASM Microbe
2017 are available from the ‘Programmes’ section of Summit’s
website, www.summitplc.com.
Ridinilazole successfully completed a Phase 2
proof of concept clinical trial where it demonstrated statistical
superiority against vancomycin in sustained clinical response, an
endpoint defined in the clinical trial as clinical cure at the end
of treatment and no recurrence of CDI within 30 days of the end of
therapy. Ridinilazole is currently being prepared for Phase 3
clinical trials, which are planned to commence during the first
half of 2018.
About C.
difficile InfectionC. difficile infection is a
serious healthcare threat in hospitals, long-term care homes and
increasingly the wider community with over one million estimated
cases of CDI each year in the United
States and Europe. It 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. 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
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 designation 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 programs 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 7213 0880 |
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N+1 Singer (Broker)Aubrey Powell / Lauren
Kettle |
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Tel: +44
(0)20 7496 3000 |
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MacDougall Biomedical Communications(US media
contact)Karen Sharma |
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Tel: +1
781 235 3060ksharma@macbiocom.com |
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Consilium
Strategic Communications (Financial public relations,
UK)Mary-Jane Elliott / Sue Stuart / Jessica Hodgson / Lindsey
Neville |
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Tel: +44
(0)20 3709 5700 summit@consilium-comms.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, 2017. 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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