Summit Announces Positive Top-Line Data From an Exploratory Phase 2 Clinical Trial Supporting Ridinilazole as a Highly Select...
05 September 2017 - 9:00PM
Summit Therapeutics plc (NASDAQ:SMMT) (AIM:SUMM), the drug
discovery and development company advancing therapies for Duchenne
muscular dystrophy and Clostridium difficile infection (‘CDI’),
today announces positive top-line data from an exploratory Phase 2
clinical trial that support ridinilazole as a highly selective and
potent antibiotic product candidate for the treatment of CDI. In
the Phase 2 clinical trial, ridinilazole preserved the gut
microbiome of CDI patients to a greater extent than the marketed
narrow-spectrum antibiotic, fidaxomicin. During the trial’s ten-day
treatment period, ridinilazole treatment had markedly less impact
on the gut microbiome of trial patients by measures of overall
diversity and changes in key bacterial families, when compared to
those trial patients dosed with fidaxomicin.
In the trial, ridinilazole and fidaxomicin both
reduced the abundance of C. difficile. However, fidaxomicin-treated
patients had reduced abundancy of other bacterial families
associated with microbiome health. For a number of these bacterial
families, the difference between the two treatments was
statistically significant. Another measure of microbiome health is
alpha diversity as measured by the Simpson’s Diversity Index. There
was a greater reduction in alpha-diversity during fidaxomicin
treatment compared with ridinilazole-treated patients. These
measures were a key secondary endpoint of the clinical trial and
provide additional evidence of ridinilazole’s precision in killing
C. difficile while preserving the gut microbiome. The primary
endpoint of the trial was safety, as measured by the number of
treatment emergent adverse events and serious adverse events.
During the trial, no new or unexpected safety signals were
identified and ridinilazole was well-tolerated.
“We increasingly recognise the importance of a
healthy and diverse gut microbiome for protection against recurrent
CDI, which is a major challenge in the management of the disease.
These latest clinical findings show ridinilazole better preserved
the microbiome of CDI patients than fidaxomicin, the narrowest
spectrum antibiotic currently available for CDI,” commented
Professor Mark Wilcox, Consultant Microbiologist & Head of
Microbiology Research & Development at the Leeds Teaching
Hospitals NHS Trust, Professor of Medical Microbiology at the
University of Leeds, and Public Health England's Lead on C.
difficile in England. “Further, these microbiome data are
very supportive of ridinilazole’s profile as a highly selective
antibiotic with the potential to achieve a meaningful improvement
in clinical outcomes for CDI patients.”
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. The trial
population was unbalanced with more patients randomised to
ridinilazole at higher risk of poorer clinical outcomes as measured
by ATLAS score, and also with predisposing factors for recurrent
CDI.
A secondary endpoint of sustained clinical
response (‘SCR’), defined as clinical cure at the end of treatment
and no recurrence of CDI within the next 30 days, was achieved in
seven of 14 ridinilazole treated patients and six of 13 fidaxomicin
treated patients. The trial was not designed for efficacy
comparisons due to the small number of patients.
Dr David Roblin, Chief Medical and
Operating Officer of Summit added,
“Ridinilazole is a precision antibiotic that is designed to
selectively target C. difficile while being highly preserving of
the gut microbiome that plays a crucial role in naturally
protecting against recurrent CDI. Ridinilazole has now provided
evidence of its high selectivity in two complementary clinical
trials. The data from our earlier Phase 2 trial showed a greater
microbiome preservation of ridinilazole-treated patients compared
with the current standard of care, vancomycin, which led to
achieving statistical superiority in sustained clinical response.
We believe ridinilazole has the potential to become a front-line
therapy for CDI and look forward to initiating Phase 3 clinical
trials in the first half of 2018.”
More detailed findings from this trial are
expected to be presented at an upcoming international infectious
disease conference. The results build on positive data from a Phase
2 proof of concept trial of ridinilazole that were published in The
Lancet Infectious Diseases in April 2017. Ridinilazole is currently
being prepared for Phase 3 clinical trials that are planned to
commence in 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. Reducing disease recurrence 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 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.
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
5700summit@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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