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 the presentation today of major findings from the Phase 2
CoDIFy trial highlighting the potential of ridinilazole in the
treatment of CDI at the 26th European Congress of Clinical
Microbiology and Infectious Diseases (‘ECCMID’). These findings
include a markedly reduced recurrence rate and a statistically
superior rate of sustained clinical response (‘SCR’) in patients
with CDI receiving ridinilazole compared with those receiving the
standard of care, vancomycin. Ridinilazole is a novel class
antibiotic with the potential for broad use across the CDI disease
spectrum.
“Preventing disease recurrence is a major unmet
need in CDI, both for newly diagnosed patients who are receiving
initial treatment and for patients who are receiving treatment for
recurrent disease,” said Dale Gerding, MD, Research
Physician, Hines Veterans Affairs Hospital, Professor of Medicine,
Loyola University Stritch School of Medicine, and an author on the
presentation. “In this context, it is very encouraging to
see such a marked reduction in recurrences with ridinilazole in the
Phase 2 trial.”
Glyn Edwards, CEO of Summit,
added: “Ridinilazole’s narrow spectrum of activity
appeared to substantially reduce damage to the gut microbiome
in the Phase 2 clinical trial, allowing patients to maintain or
rebuild their natural defences against recurrence of CDI. The
wealth of data we have reported on the compound to date, including
the positive efficacy results presented today at ECCMID, suggest
that ridinilazole could become a truly differentiated product with
potential for broad use in CDI, including front-line
treatment.”
Key efficacy findings from the trial presented
at ECCMID were:
- Statistical superiority in SCR with rates of 66.7% for
ridinilazole compared to 42.4% for vancomycin
- Marked reduction in recurrence with rates of 14.3% for
ridinilazole compared to 34.8% for vancomycin
- Cure rates at the end of treatment of 77.8% for ridinilazole
and 69.7% for vancomycin
The primary analysis was conducted on the
modified intent-to-treat (‘mITT’) population that comprised
subjects with CDI confirmed by the presence of free toxin in
faeces. These results were consistent across the intent to treat
(‘ITT’) and per protocol (‘PP’) groups. Ridinilazole was generally
well-tolerated and the overall adverse event profiles of
ridinilazole and vancomycin were comparable.
The poster, entitled “Ridinilazole for
Clostridium difficile infections: safety and efficacy compared with
vancomycin from the CoDIFy Phase 2 clinical trial,” was 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. Other
authors on the poster were RJ Vickers, GS Tillotson, R Nathan, S
Hazan, C Lucasti, J Pullman, J Deck, B Maliakkal, Y Pesant, B
Yacyshyn and DN Gerding.
A copy of the poster is available from Summit’s
website: www.summitplc.com/publications.
About CoDIFyCoDIFy 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). The results of the trial showed ridinilazole achieved
statistical superiority in SCR with 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. 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) 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
(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 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 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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