Summit Therapeutics Completes Targeted Enrolment for SMT19969 Phase 2 Trial for C. difficile Infection
September 21 2015 - 7:46PM
Summit Therapeutics plc (NASDAQ:SMMT) (AIM:SUMM), the drug
discovery and development company advancing therapies for Duchenne
muscular dystrophy ('DMD') and Clostridium difficile infection
('CDI'), today announced the completion of patient enrolment into
the CoDIFy Phase 2 proof of concept trial of SMT19969 for the
treatment of CDI. Patient dosing and follow-up is continuing and
top-line results are expected in the fourth quarter of 2015.
SMT19969 is a novel, oral antibiotic designed to selectively target
C. difficile bacteria while not harming the gut microbiome that is
essential in protecting against disease recurrence.
"CDI is now widely accepted to be a major healthcare issue, and
with current antibiotics used to treat CDI having high rates of
disease recurrence, there is an urgent need to develop new
therapies," said Glyn Edwards, Chief Executive Officer of
Summit. "We believe SMT19969 represents an important
advance as its potency in killing C. difficile bacteria is
complemented by selective targeting that leaves the healthy gut
microbiome unharmed. The timely completion of enrolment into our
CoDIFy proof of concept trial achieves an important milestone and
means we remain on-track to report top-line results in the fourth
quarter of this year."
C. difficile is one of three pathogens that pose an immediate
public health threat according to the US Center for Disease Control
and Prevention ('CDC'). CDI has a high economic impact with
annual acute care costs estimated at $4.8 billion in the United
States alone. The key clinical issue is disease recurrence
with approximately 25% of patients suffering recurrence of CDI, a
risk that rises to 40% after a first recurrence and over 65% after
a second recurrence.
SMT19969 has received Qualified Infectious Disease Product
designation ('QIDP') and Fast Track status from the US Food and
Drug Administration. The development of SMT19969 is being
supported by a Wellcome Trust Translational Award.
About CoDIFy Phase 2 Clinical Trial
CoDIFy, is a double-blind, randomized, active control Phase 2
trial evaluating the efficacy of SMT19969 against the current
standard of care, vancomycin. CoDIFy is being conducted in the
United States and Canada. The trial has enrolled a total of 100
patients, with half receiving ten days of dosing with SMT19969, and
half receiving ten days of dosing with vancomycin. The primary
endpoint of the trial is sustained clinical response, a composite
endpoint which is defined as clinical cure at the test of cure
visit with no recurrence of CDI within 30 days after the end of
treatment. The trial is also examining a number of secondary
endpoints, including the safety and tolerability of SMT19969 and
its impact on patients' gut microbiome.
About SMT19969
SMT19969 is a novel, oral small molecule antibiotic that is
being developed specifically for the treatment of CDI. Results from
non-clinical efficacy studies show that SMT19969 combines potent
bactericidal activity against C. difficile with high levels of
antibacterial selectivity. A Phase 1 trial conducted in healthy
volunteers showed SMT19969 to be well tolerated at all doses
tested. In addition, a significant reduction in total clostridia
but not in other bacterial groups was reported, demonstrating that
SMT19969 was highly sparing of the gut microbiome.
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).
For more information, please contact:
Summit Therapeutics |
|
Glyn Edwards / Richard Pye
(UK office) |
Tel: +44 (0)1235 443 951 |
Erik Ostrowski (US office) |
+1 617 294 6607 |
|
|
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) |
Tel: +1 781 235 3060 |
Michelle Avery |
mavery@macbiocom.com |
|
|
Peckwater PR |
|
(Financial public relations, UK) |
Tel: +44 (0)7879 458 364 |
Tarquin Edwards |
tarquin.edwards@peckwaterpr.co.uk |
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statements about the clinical and preclinical development of
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Actual results may differ materially from those indicated by such
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on-going and future clinical trials and the results of such trials,
whether preliminary results from a clinical trial will be
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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
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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, 2015. Accordingly
readers should not place undue reliance on forward looking
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