Summit Highlights Microbiome Preservation During Ridinilazole Treatment in Exploratory Phase 2 Clinical Trial at ID Week 2017...
09 Octobre 2017 - 1:00PM
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 that at ID Week 2017, it presented further positive gut
microbiome data of ridinilazole from its exploratory Phase 2
clinical trial. As was previously reported, the Company’s novel and
highly selective antibiotic, ridinilazole, was more preserving of
patients’ gut microbiomes during a ten-day treatment period of the
Phase 2 clinical trial than the marketed narrow-spectrum
antibiotic, fidaxomicin.
“The impressive level of microbiome detail
afforded by our clinical analyses shows the low impact of
ridinilazole treatment on the gut microbiomes of patients while
they are being treated for CDI,” said Dr David Roblin,
Chief Medical and Operating Officer of Summit. “We believe
ridinilazole is a precision antibiotic that combines low impact on
the gut microbiome with high potency in killing C. difficile and
that, with this profile, and its consequent potential to reduce
recurrent disease, it could become a future front-line treatment
option in CDI.”
Ridinilazole’s antimicrobial activity was
limited to two bacterial families, one including C. difficile and
the other a closely related family. Fidaxomicin reduced the
abundancy of these families as well, but also reduced the abundancy
of additional bacterial families, including reductions to bacteria
belonging to the Firmicutes phylum that are thought to have direct
functional roles in protecting against CDI. Another important
measure of microbiome health is alpha-diversity. In this measure,
ridinilazole treatment resulted in no loss in median alpha
diversity, whereas fidaxomicin treatment was associated with loss
of alpha diversity during dosing.
The poster, “Preservation of Gut Microbiome
Following Ridinilazole versus Fidaxomicin Treatment of Clostridium
difficile Infection,” was authored by S. Mitra, C. Chilton, J.
Freeman, M. Taylor, P. Quirke, H. Wood and MH Wilcox of Leeds
Teaching Hospitals and RJ Vickers of Summit. It is available for
download on the Publications page of Summit’s website,
www.summitplc.com.
About C. difficile Infection
C. 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. Reducing disease recurrence is the key
clinical issue in CDI 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 the Exploratory Phase 2 Clinical
Trial
The exploratory open-label Phase 2 clinical
trial enrolled 27 patients aged between 18 and 90 years at trial
sites in the US, the UK and the Czech Republic. Patients were
randomly assigned to receive either ridinilazole (200mg, twice a
day) or fidaxomicin (200mg, twice a day) for ten days.
About Ridinilazole
Ridinilazole is a small molecule antibiotic that
Summit is developing for the treatment of CDI. In preclinical
efficacy studies, ridinilazole exhibited a targeted spectrum of
activity that combined a potent bactericidal effect against all
clinical isolates of C. difficile tested with minimal
impact on other bacteria that are typically found in the gut
microbiome. 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 that 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 was also shown to be highly preserving of the
gut microbiome in the Phase 2 proof of concept trial, which was
believed to be the reason for the improved clinical outcome for the
ridinilazole-treated patients. In addition, ridinilazole preserved
the gut microbiome to a greater extent than the marketed
narrow-spectrum antibiotic fidaxomicin in an exploratory Phase 2
clinical trial. Ridinilazole, an orally administered small
molecule, 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) |
Tel: +44 (0)1235 443 951+1
617 225 4455 |
Cairn Financial Advisers LLP(Nominated
Adviser)Liam Murray / Tony Rawlinson |
Tel: +44 (0)20 7213
0880 |
N+1
Singer (Broker)Aubrey Powell / Lauren Kettle
|
Tel: +44 (0)20 7496
3000 |
MacDougall Biomedical Communications (US
media contact)Karen Sharma |
Tel: +1 781 235
3060ksharma@macbiocom.com |
Consilium Strategic Communications (Financial
public relations, UK)Mary-Jane Elliott / Sue Stuart / Jessica
Hodgson / Lindsey Neville |
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.
This announcement contains inside information
for the purposes of Article 7 of EU Regulation 596/2014 (MAR).
-END-
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