Phase 2 CoDIFy Trial Results Published in Lancet Infectious Diseases With Data Showing Summit’s Ridinilazole Achieved Stati...
April 28 2017 - 6:30PM
Summit Therapeutics plc (AIM:SUMM) (NASDAQ:SMMT), the drug
discovery and development company advancing therapies for Duchenne
muscular dystrophy and C. difficile infection (‘CDI’), announces
the online publication of results from the Company’s Phase 2
clinical trial, called CoDIFy, in The Lancet Infectious Diseases.
CoDIFy evaluated the Company’s novel antibiotic for the treatment
of CDI, ridinilazole, against standard of care, vancomycin. The
results showed ridinilazole demonstrated substantial clinical
benefit over vancomycin. This included ridinilazole achieving
statistical superiority over vancomycin in sustained clinical
response (‘SCR’), a composite endpoint of cure at the end of
treatment and no recurrence 30 days after treatment, a result which
was driven by a large numerical reduction in infection recurrence.
“CDI is a serious disease that is a major
healthcare challenge due to the high recurrence rates which are
believed to be exacerbated by the broad spectrum antibiotics we use
to treat CDI today,” Professor Mark Wilcox, University of
Leeds and Principal Investigator in CoDIFy commented. “A
highly selective antibiotic has the potential to transform the
current treatment paradigm and keep recurrent CDI at bay. The
ability of ridinilazole to provide a significant increase in
sustained clinical responses compared with the standard of care in
CoDIFy provides evidence that ridinilazole is highly selective and
warrants its continued clinical development.”
Key results from CoDIFy published in The Lancet
Infectious Diseases:
- Ridinilazole achieved statistical superiority in sustained
clinical response (‘SCR’) with rates of 66.7% compared with 42.4%
for vancomycin.
- Ridinilazole achieved a large numerical reduction in recurrent
disease over vancomycin (14.3% recurrence with ridinilazole vs.
34.8% recurrence with vancomycin).
- Ridinilazole met the pre-specified endpoint of non-inferiority
on cure rates at the end of treatment (77.8% for ridinilazole vs.
69.7% for vancomycin).
- Median time to resolution of diarrhoea favoured ridinilazole
(four days on ridinilazole vs. five days on vancomycin) and
numerically more subjects on ridinilazole had resolution of
diarrhoea compared with vancomycin by day six (77.8% vs.
63.6%).
- Median time to hospital discharge was five days for
ridinilazole-treated subjects versus seven days for
vancomycin-treated subjects.
- Ridinilazole was retained in the gut, the site of infection,
with negligible systemic exposure observed.
- Adverse event profiles were similar between
ridinilazole-treated and vancomycin-treated subjects, with no
safety signals being identified with ridinilazole.
Mr Glyn Edwards, Chief Executive Officer
of Summit, added: “The results of our CoDIFy trial
provided further evidence of ridinilazole’s ability to address the
key clinical issue of recurrence, which could lead to improved
patient care and reduced economic burden of CDI. We are therefore
planning to progress this novel programme into Phase 3 clinical
trials. With ridinilazole, we believe we have a promising potential
treatment option for this potentially fatal infectious
disease.”
Ridinilazole is now being prepared for entry
into a Phase 3 clinical programme that is expected to comprise two
Phase 3 trials evaluating ridinilazole compared to vancomycin. The
primary endpoint of the Phase 3 clinical trials is expected to be
testing for superiority on sustained clinical response. The Phase 3
clinical trials are planned to start in the first half of 2018.
The publication reference is Lancet Infect Dis 2017; published
online Apr 28:
http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(17)30235-9/fulltext?elsca1=tlxpr.
About CoDIFy CoDIFy was a
double blind, randomized, active controlled, multi-centre, Phase 2
clinical trial that evaluated the efficacy of ridinilazole against
vancomycin in a total of 100 patients. Half of the patients
received ridinilazole for ten days (200 mg, twice a day), and the
remaining half received vancomycin for ten days (125 mg, four times
a day). In addition to the results described above, ridinilazole
was found to be highly preserving of the gut microbiome.
Ridinilazole treated patients in CoDIFy exhibited no further damage
to their microbiome during therapy with a proportion of patients
showing initial evidence of recovery of key bacterial groups with
roles in protecting from CDI. In contrast, vancomycin treated
patients suffered substantial damage to their gut microbiome during
treatment and this persisted in many patients during the 30-day
post treatment period.
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.
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
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 TherapeuticsSummit
is a biopharmaceutical company focused on the discovery,
development and commercialization 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
Therapeutics 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)Chris Erdman /
Karen Sharma |
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Tel: +1 781 235 3060
cerdman@macbiocom.com |
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ksharma@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
5700summit@consilium-comms.com |
Forward Looking StatementsAny
statements in this press release about our future expectations,
plans and prospects, including statements about development and
potential commercialisation of our product candidates, the
therapeutic potential of our product candidates, the timing of
initiation, completion and availability of data from clinical
trials, any other potential third-party collaborations and
expectations regarding the sufficiency of our cash balance to fund
operating expenses and capital expenditures, 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
ongoing 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 will be indicative of the results of later
clinical trials, expectations for regulatory approvals,
availability of funding sufficient for our foreseeable and
unforeseeable operating expenses and capital expenditure
requirements and other factors discussed in the "Risk Factors"
section of filings that we make with the Securities and Exchange
Commission, including our Annual Report on Form 20-F for the fiscal
year ended 31 January 2017. In addition, any forward-looking
statements included in this press release represent our views only
as of the date of this release and should not be relied upon as
representing our views as of any subsequent date. We specifically
disclaim any obligation to update any forward-looking statements
included in this press release.
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