Summit to Present Phase 2 CoDIFy Trial Data Highlighting Ridinilazole's Preservation of the Microbiome in CDI Patients at ASM...
23 May 2016 - 9:00PM
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 that the Company will present additional positive Phase 2
CoDIFy trial data on ridinilazole versus standard of care,
vancomycin, highlighting ridinilazole’s preservation of the
microbiome in the treatment of CDI. These data will be presented as
posters at the ASM Microbe 2016 meeting that will be held 16-20
June 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. The data to be presented at ASM Microbe, including
additional results from CoDIFy, further highlight ridinilazole as a
highly selective antibiotic for CDI with the potential to treat the
initial infection and reduce recurrent disease, the key clinical
issue in the treatment of CDI.
All of the poster presentations take place on 20
June 2016 from 12:30-14:30 EDT. Details are as follows:
Session: Monday Late-Breaker Poster
PresentationsAbstract Number:
LB-116Title: Ridinilazole Preserves Major
Components of the Intestinal Microbiota During Treatment of
Clostridium difficile InfectionAuthors: J. Chang,
A. Kane, L. McDermott, R. J. Vickers, D. R. Snydman, C. M.
Thorpe
Session: Clostridium difficile: Efficacy of New
Therapeutic InterventionsAbstract Number:
MONDAY-440Title: Ridinilazole (RDZ) for
Clostridium difficile Infection (CDI) – Further Data from the
CoDIFy Phase 2 Clinical TrialAuthors: R. J.
Vickers, M. H. Wilcox, D. N. Gerding
Session: Clostridium difficile: Efficacy of New
Therapeutic InterventionsAbstract Number:
MONDAY-441Title: Ridinilazole for Clostridium
difficile Infection (CDI). Reductions in Calprotectin and
Lactoferrin During TherapyAuthors: Y. Ke, R.
Vickers, Y-X. Li
Session: Clostridium difficile: Efficacy of New
Therapeutic InterventionsAbstract Number:
MONDAY-442Title: Analysis of C. difficile Isolated
from Stools of Patients Enrolled in a Phase II Clinical Trial of
Ridinilazole (SMT19969)Authors: D. R. Snydman, L.
A. McDermott, C. M. Thorpe, J. Chang, J. Wick S. T. Walk, R.
Vickers
Session: Clostridium difficile: Efficacy of New
Therapeutic InterventionsAbstract Number:
MONDAY-443Title: Resistance Development Studies
with Ridinilazole (RDZ) and Clostridium
difficileAuthors: D. Hall, C. Pillar, R.
Vickers, D. Shinabarger
About C. difficile Infection C.
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 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 |
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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