Summit Therapeutics plc Summit Therapeutics Plc: Phase 2 Codify Trial Results Published In Lancet Infectious Diseases
May 02 2017 - 1:00AM
UK Regulatory
TIDMSUMM
Summit Therapeutics plc
('Summit', or the 'Company')
PHASE 2 CoDIFy TRIAL RESULTS PUBLISHED IN LANCET INFECTIOUS DISEASES
WITH DATA SHOWING SUMMIT'S RIDINILAZOLE ACHIEVED STATISTICAL SUPERIORITY
OVER VANCOMYCIN IN THE TREATMENT OF C. DIFFICILE INFECTION
Oxford, UK, 2 May 2017 - Summit Therapeutics plc (AIM: SUMM, NASDAQ:
SMMT), the drug discovery and development company advancing therapies
for Duchenne muscular dystrophy and C. difficile infection ('CDI'),
announces the online publication of results from the Company's Phase 2
clinical trial, called CoDIFy, in The Lancet Infectious Diseases. CoDIFy
evaluated the Company's novel antibiotic for the treatment of CDI,
ridinilazole, against standard of care, vancomycin. The results showed
ridinilazole demonstrated substantial clinical benefit over vancomycin.
This included ridinilazole achieving statistical superiority over
vancomycin in sustained clinical response ('SCR'), a composite endpoint
of cure at the end of treatment and no recurrence 30 days after
treatment, a result which was driven by a large numerical reduction in
infection recurrence.
"CDI is a serious disease that is a major healthcare challenge due to
the high recurrence rates which are believed to be exacerbated by the
broad spectrum antibiotics we use to treat CDI today," Professor Mark
Wilcox, University of Leeds and Principal Investigator in CoDIFy
commented. "A highly selective antibiotic has the potential to transform
the current treatment paradigm and keep recurrent CDI at bay. The
ability of ridinilazole to provide a significant increase in sustained
clinical responses compared with the standard of care in CoDIFy provides
evidence that ridinilazole is highly selective and warrants its
continued clinical development."
Key results from CoDIFy published in The Lancet Infectious Diseases:
-- Ridinilazole achieved statistical superiority in sustained clinical
response ('SCR') with rates of 66.7% compared with 42.4% for vancomycin.
-- Ridinilazole achieved a large numerical reduction in recurrent disease
over vancomycin (14.3% recurrence with ridinilazole vs. 34.8% recurrence
with vancomycin).
-- Ridinilazole met the pre-specified endpoint of non-inferiority on cure
rates at the end of treatment (77.8% for ridinilazole vs. 69.7% for
vancomycin).
-- Median time to resolution of diarrhoea favoured ridinilazole (four days
on ridinilazole vs. five days on vancomycin) and numerically more
subjects on ridinilazole had resolution of diarrhoea compared with
vancomycin by day six (77.8% vs. 63.6%).
-- Median time to hospital discharge was five days for ridinilazole-treated
subjects versus seven days for vancomycin-treated subjects.
-- Ridinilazole was retained in the gut, the site of infection, with
negligible systemic exposure observed.
-- Adverse event profiles were similar between ridinilazole-treated and
vancomycin-treated subjects, with no safety signals being identified with
ridinilazole.
Mr Glyn Edwards, Chief Executive Officer of Summit, added: "The results
of our CoDIFy trial provided further evidence of ridinilazole's ability
to address the key clinical issue of recurrence, which could lead to
improved patient care and reduced economic burden of CDI. We are
therefore planning to progress this novel programme into Phase 3
clinical trials. With ridinilazole, we believe we have a promising
potential treatment option for this potentially fatal infectious
disease."
Ridinilazole is now being prepared for entry into a Phase 3 clinical
programme that is expected to comprise two Phase 3 trials evaluating
ridinilazole compared to vancomycin. The primary endpoint of the Phase 3
clinical trials is expected to be testing for superiority on sustained
clinical response. The Phase 3 clinical trials are planned to start in
the first half of 2018.
The publication reference is Lancet Infect Dis 2017; published online
Apr 28:
http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(17)30235-9/fulltext?elsca1=tlxpr.
About CoDIFy
CoDIFy 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). In addition to the results described above, 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 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 Therapeutics
Summit 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 https://twitter.com/Summitplc ).
For more information, please contact:
Summit Therapeutics
Glyn Edwards / Richard Pye (UK office) Tel: +44 (0)1235 443 951
Erik Ostrowski / Michelle Avery (US office) +1 617 225 4455
Cairn Financial Advisers LLP
(Nominated Adviser) Tel: +44 (0)20 7213 0880
Liam Murray / Tony Rawlinson
N+1 Singer
(Broker) Tel: +44 (0)20 7496 3000
Aubrey Powell / Lauren Kettle
MacDougall Biomedical Communications
(US media contact) Tel: +1 781 235 3060
Chris Erdman / Karen Sharma cerdman@macbiocom.com ksharma@macbiocom.com
Consilium Strategic Communications
(Financial public relations, UK) Tel: +44 (0)20 3709 5700
Mary-Jane Elliott / Sue Stuart / summit@consilium-comms.com
Jessica Hodgson / Lindsey Neville
Forward Looking Statements
Any 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, any other
potential third-party collaborations and expectations regarding the
sufficiency of our cash balance to fund operating expenses and capital
expenditures, 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 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 2017. 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.
- END -
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Source: Summit Therapeutics plc via Globenewswire
http://www.summitplc.com/
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