Summit Outlines Phase 3 Programme for Novel CDI Antibiotic Ridinilazole Following FDA and EMA Regulatory Meetings
February 01 2017 - 7:00AM
Summit Therapeutics plc (AIM:SUMM) (NASDAQ:SMMT), the drug
discovery and development company advancing therapies for Duchenne
muscular dystrophy and C. difficile infection (‘CDI’), today
outlines its Phase 3 programme for its novel antibiotic,
ridinilazole, following recent regulatory meetings with the US Food
and Drug Administration (‘FDA’) and European Medicines Agency
(‘EMA’). With input from the FDA and EMA, Summit intends to design
the Phase 3 clinical programme to evaluate superiority of
ridinilazole over standard of care in the treatment of CDI. A
positive Phase 3 result on superiority has the potential to support
the commercial launch of ridinilazole as a differentiated therapy
that can both treat initial CDI and reduce disease recurrence.
Mr Glyn Edwards, Chief Executive Officer
of Summit commented: “The constructive end of Phase 2
meetings with the US and European regulators have enabled us to
design a Phase 3 programme that focuses on evaluating
ridinilazole’s superiority over standard of care. This is something
we believe would help differentiate our novel class antibiotic from
currently marketed CDI treatments and those in late-stage
development. Superiority in the combined measure of treatment of
initial infection and importantly, reduction in recurrence, could
position ridinilazole for front-line treatment of CDI.”
Summit discussed its Phase 3 development
programme with the FDA at an End of Phase 2 meeting and through a
scientific advice process with EMA. With input from both agencies,
the Phase 3 programme is expected to include two trials evaluating
ridinilazole as compared to the standard of care, vancomycin, each
of which would enrol approximately 700 patients with CDI with the
primary endpoint being superiority in sustained clinical response
(‘SCR’). Other planned endpoints will include health economic
outcome measures. The Phase 3 trial designs are consistent with the
successful proof of concept Phase 2 trial, CoDIFy, in which
ridinilazole achieved statistical superiority over vancomycin in
SCR. SCR is a combined endpoint that measures cure at the end of
treatment and a lack of recurrence in the 30 days after treatment.
FDA also confirmed that ridinilazole would be eligible for Priority
Review based on its QIDP designation.
Mr Edwards continued: “As we
continue to evaluate our options to maximise the value of
ridinilazole, our stronger financial position following the DMD
programme partnership with Sarepta Therapeutics, Inc. means Summit
has more time to fully explore all options. These include
potentially entering into a collaboration with a third party or
securing meaningful non-dilutive funding from government and
charitable organisations. In parallel, activities to prepare
ridinilazole for Phase 3 trials continue with these anticipated to
start in the first half of 2018.”
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 and 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
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) |
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Tel: +44 (0)1235 443
951 +1 617 225 4455 |
Cairn Financial
Advisers LLP (Nominated Adviser)Liam Murray / Tony
Rawlinson |
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Tel: +44 (0)20 7213
0880 |
N+1
Singer (Broker)Aubrey Powell / Lauren Kettle |
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Tel: +44
(0)20 7496 3000 |
MacDougall
Biomedical Communications(US media contact)Chris Erdman /
Karen Sharma |
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Tel: +1 781 235 3060
cerdman@macbiocom.comksharma@macbiocom.com |
Consilium
Strategic Communications (Financial public relations,
UK)Mary-Jane Elliott / Sue Stuart / Jessica Hodgson / Lindsey
Neville |
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Tel: +44 (0)20 3709
5700summit@consilium-comms.com |
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Forward Looking StatementsAny
statements in this press release about our future expectations,
plans and prospects, including statements about development and
potential commercialisation of our product candidates, the
therapeutic potential of our product candidates, the timing of
initiation, completion and availability of data from clinical
trials, the potential benefits and future operation of the
collaboration with Sarepta Therapeutics Inc., including any
potential future payments thereunder, any other potential
third-party collaborations and expectations regarding the
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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 ongoing 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 will be
indicative of the results of later clinical trials, expectations
for regulatory approvals, availability of funding sufficient for
our foreseeable and unforeseeable operating expenses and capital
expenditure requirements and other factors discussed in the "Risk
Factors" section of filings that we make with the Securities and
Exchange Commission, including our Annual Report on Form 20-F for
the fiscal year ended 31 January 2016. In addition, any
forward-looking statements included in this press release represent
our views only as of the date of this release and should not be
relied upon as representing our views as of any subsequent date. We
specifically disclaim any obligation to update any forward-looking
statements included in this press release.
This announcement contains inside information for
the purposes of Article 7 of EU Regulation 596/2014 (MAR).
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