Summit Therapeutics plc (AIM:SUMM) (NASDAQ:SMMT), the drug
discovery and development company advancing therapies for Duchenne
muscular dystrophy and Clostridium difficile infection (‘CDI’),
announces the presentation of further clinical trial data showing
ridinilazole outperformed the standard of care, vancomycin, in the
preservation of the gut microbiome of patients during treatment for
CDI. These data were derived from the Phase 2 CoDIFy trial and are
being presented today during ASM Microbe 2016 in Boston, MA, US.
Ridinilazole is part of a novel structural class
of antibiotics with potential for broad use in the treatment of
CDI. As previously reported, in a Phase 2 clinical trial called
CoDIFy, ridinilazole demonstrated substantial clinical benefit over
vancomycin, including a large numerical reduction in recurrent
disease. Recurrence of CDI, and consequent failure to achieve a
sustained response after treatment, is a major issue in the
management of the condition and is promoted by disruption of the
gut microbiome, which occurs with current mainstay treatments such
as vancomycin.
“Ridinilazole is a shining example of
translational medicine, where its high selectivity in the lab has
read through to a preserved microbiome in trial patients,
ultimately resulting in significantly more sustained clinical
responses in a Phase 2 trial compared to the standard of care,”
said Dale Gerding, MD, Research Physician, Hines Veterans
Affairs Hospital, Professor of Medicine, Loyola University Stritch
School of Medicine. “These and additional supporting data
presented at ASM Microbe show the broad potential of ridinilazole
as a novel treatment for CDI, and I look forward to its continued
clinical development.”
In the presentation entitled “Ridinilazole
Preserves Major Components of the Intestinal Microbiota During
Treatment of Clostridium difficile Infection,” stool samples were
obtained from 82 patients enrolled in the CoDIFy Phase 2 trial
evaluating the efficacy of ridinilazole compared to vancomycin.
These samples were analysed on study entry, days five and ten of
treatment, days 25 and 40 post-entry as well as at the time of any
recurrence for five specific bacterial groups associated with a
healthy gut microbiome (Bacteroides, Prevotella, Enterbactericeae,
C. coccoides and C. leptum) and also for total bacteria present.
Treatment with vancomycin resulted in a significant decrease
(p<0.001) in four of the five bacterial groups (Bacteroides,
Prevotella, C. coccoides and C. leptum) at days five and ten, and
also resulted in a significant decrease in total bacteria. In
contrast, treatment with ridinilazole did not significantly
decrease these specific bacterial groups nor the total bacteria.
These data suggest ridinilazole may have advantages compared to
vancomycin in preserving a healthy gut microbiome during treatment
for CDI.
A new analysis from the CoDIFy study evaluating
rates of sustained clinical response in prospectively defined
subgroups of patients at high risk for recurrence is also being
presented at the meeting. Consistent with findings from the entire
modified intent-to-treat patient population, where ridinilazole
achieved statistical superiority over vancomycin in sustained
clinical responses (66.7% vs 42.4%), there were trends favouring
ridinilazole in most of these groups, including older patients,
those with severe disease and those with previous CDI episodes.
Notably, among patients aged 75 and over, 83% (5/6) of patients on
ridinilazole had sustained clinical responses compared with 22%
(2/9) on vancomycin.
Other posters on ridinilazole presented today
report biomarker findings from CoDIFy, data on susceptibility of C.
difficile isolates from the trial to antimicrobial agents, and in
vitro studies of resistance development.
Copies of all the posters are available from Summit’s website,
www.summitplc.com/publications. In addition, a video featuring
leading CDI experts, Professor Mark Wilcox of the University of
Leeds and Dr Dale Gerding of Hines Veterans Affairs Hospital and
Loyola University Stritch School of Medicine, discussing the
promise of ridinilazole in the treatment of CDI is available on
Summit’s homepage www.summitplc.com.
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 sustained clinical response (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 this trial, 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, 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
(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
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) |
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 |
|
|
MacDougall
Biomedical Communications(US media contact)Chris Erdman /
Karen Sharma |
Tel: +1 781 235 3060
cerdman@macbiocom.com /ksharma@macbiocom.com |
|
|
Consilium
Strategic Communications (Financial public relations,
UK)Mary-Jane Elliott / Sue Stuart / Jessica Hodgson / Lindsey
Neville |
Tel: +44 (0)20 3709 5700
summit@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, 2016. 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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