Summit to Present Additional Data From Phase 2 CoDIFy Trial Showing Ridinilazole’s Statistical Superiority Over Vancomycin ...
29 Mars 2016 - 3:25PM
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 it will present additional data from the Phase 2
CoDIFy trial at the 26th European Congress of Clinical Microbiology
and Infectious Diseases (‘ECCMID’). In the accompanying abstract
published online today, data from Summit’s Phase 2 CoDIFy trial
demonstrated that administration of the narrow spectrum antibiotic
ridinilazole resulted in a marked reduction in rates of CDI
recurrence as compared to standard of care vancomycin (14.3% vs.
34.8%). This result drove the previously reported statistical
superiority in sustained clinical response rates of ridinilazole
over vancomycin (66.7% vs 42.4%) in the treatment of CDI. Sustained
clinical response was defined as clinical cure at the end of
treatment and no recurrence in the 30 days after therapy.
Recurrence is the key clinical issue in the treatment of CDI as
repeat episodes are typically more severe and associated with an
increase in mortality rates and healthcare costs.
Rates of clinical cure at the end of treatment
in the Phase 2 CoDIFy trial were 77.8% for ridinilazole and 69.7%
for vancomycin. These analyses were conducted on the modified
intent-to-treat (‘mITT’) population that comprised subjects with
CDI diagnosed by the presence of free toxin in faeces.
The related poster, entitled “Ridinilazole for
Clostridium difficile infections: safety and efficacy compared with
vancomycin from the CoDIFy Phase 2 clinical trial,” will be
presented by Professor Mark H. Wilcox, Consultant Microbiologist
& Head of Microbiology 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,
on 11 April 2016, from 13:00-14:00 CEST in Amsterdam,
Netherlands.
About CoDIFyCoDIFy was a double
blind, randomized, active controlled, multi-centre, Phase 2
clinical trial that evaluated the efficacy of ridinilazole
(formerly known as SMT19969) 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). The results of the trial
showed ridinilazole achieved statistical superiority in SCR using
the pre-specified 90% confidence interval, with SCR rates of 66.7%
compared to 42.4% for vancomycin. SCR is defined as cure at the end
of therapy and no recurrent disease 30 days post end of therapy.
The primary analysis was conducted on the modified intent-to-treat
(‘mITT’) population that comprised subjects with CDI diagnosed by
the presence of free toxin in faeces. In preliminary analysis of
the gut microbiome, 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.
Notes to Editors
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) microbiome
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 in CDI as repeat episodes are typically more severe and
associated with an increase in mortality 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
(previously known as 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 highly selective 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 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 7148 7900 |
N+1 Singer (Broker)Aubrey Powell / Jen
Boorer |
Tel: +44 (0)20 7496 3000 |
Peckwater PR(Financial public relations,
UK)Tarquin Edwards |
Tel: +44
(0)7879 458 364 tarquin.edwards@peckwaterpr.co.uk |
MacDougall Biomedical Communications(US media
contact)Chris Erdman |
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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