Summit Announces Ridinilazole Preserves the Gut Microbiome of Patients With C. difficile Infection in Phase 2 Trial
March 09 2016 - 6:46PM
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 additional positive data from the CoDIFy Phase 2 clinical
trial that show the narrow spectrum antibiotic ridinilazole
preserves the gut microbiome in CDI patients while the standard of
care, vancomycin, inflicts substantial and long-lasting damage on
the gut microbiome.
“CDI results from damage to the microbiome, and
patients experience further collateral damage through the use of
broad spectrum antibiotics to treat CDI, leaving them vulnerable to
recurrent disease,” commented David R. Snydman, MD, FACP,
FIDSA, Chief, Division of Geographic Medicine and Infectious
Diseases and Hospital Epidemiologist of Tufts University School of
Medicine. “New, selective antibiotics are needed to
minimise these high recurrence rates, and ridinilazole demonstrates
an exceptional ability to preserve a patient’s microbiome and allow
the growth of protective bacteria, which are vital to protecting
against CDI.”
Preliminary analysis of these new data show
ridinilazole 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 stark 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.
“These new results from the Phase 2 trial show
ridinilazole preserves the patients’ microbiome while
simultaneously working to eradicate the C. difficile bacteria. The
clinical data strongly suggest that ridinilazole treatment may be
better able to protect against recurrent disease than the current
standard of care,” commented Glyn Edwards, Chief Executive
Officer of Summit Therapeutics. “We believe this approach
offers a clear advantage over conventional broad spectrum
antibiotics currently used to treat CDI that cause substantial
damage to the gut microbiome or approaches that aim to artificially
re-establish a damaged gut microbiome following antibiotic
treatment.”
“As evidenced by our growing body of clinical
and preclinical data, we believe ridinilazole has the ideal profile
to become a single therapeutic approach capable of both treating
the initial infection and reducing the high rates of recurrent
disease.”
These key microbiome findings strongly support
recently reported results from the Phase 2 CoDIFy trial that showed
ridinilazole to be statistically superior to vancomycin in
sustained clinical response (‘SCR’), a combined endpoint capturing
both initial cure and rates of recurrent CDI, with the improved SCR
rate following ridinilazole treatment being driven by a large
numerical reduction in recurrence. Full microbiome data are
expected to be published at a scientific conference in due
course.
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. 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. These additional data on the preserving
effect ridinilazole had on the gut microbiome support the top-line
Phase 2 data and improvement observed in rates of recurrent
disease.
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
(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 |
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Cairn
Financial Advisers LLP(Nominated Adviser)Liam Murray /
Tony Rawlinson |
Tel:
+44 (0)20 7148 7900 |
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N+1
Singer (Broker)Aubrey Powell / Jen Boorer |
Tel:
+44 (0)20 7496 3000 |
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Peckwater PR(Financial public relations,
UK)Tarquin Edwards |
Tel: +44
(0)7879 458 364 tarquin.edwards@peckwaterpr.co.uk |
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MacDougall Biomedical Communications(US media
contact)Chris Erdman |
Tel: +1 781
235 3060cerdman@macbiocom.com |
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