Summit Announces Further US Patent Granted for CDI Antibiotic Ridinilazole
April 28 2016 - 6:00AM
Summit Therapeutics plc (AIM:SUMM) (NASDAQ:SMMT), the drug
discovery and development company advancing therapies for Duchenne
muscular dystrophy (‘DMD’) and Clostridium difficile infection
(‘CDI’), announces the strengthening of the intellectual property
estate protecting ridinilazole following the grant of a composition
of matter patent by the United States Patent and Trademark Office.
Ridinilazole is a novel class antibiotic with potential for
broad use in the treatment of CDI. In a Phase 2 clinical trial,
ridinilazole showed statistical superiority over vancomycin in
rates of sustained clinical response, an endpoint that captures
both initial cure and recurrence of CDI.
“This new patent grant in one of our potential major commercial
markets substantially strengthens our intellectual property estate
protecting our novel CDI antibiotic ridinilazole and supports our
efforts to maximise the potential of this promising compound,”
commented Glyn Edwards, Chief Executive Officer of
Summit. “We are focused on advancing our CDI and DMD
programmes and today’s news, combined with the recently announced
expansion of our PhaseOut DMD trial, highlights their continuing
excellent progress as we seek to have a meaningful impact on the
lives of patients living with these serious diseases.”
The patent (United States Patent 9,314,456) is entitled
‘Antibacterial Compounds’, and provides a period of exclusivity for
ridinilazole in the United States until at least 1 December 2029,
with the possibility of patent term extension.
Notes to Editors
About C. difficile InfectionC. 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 RidinilazoleRidinilazole (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 status 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 |
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Cairn
Financial Advisers LLP (Nominated Adviser)Liam Murray /
Tony Rawlinson |
Tel:
+44 (0)20 7148 7900 |
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N+1
Singer (Broker)Aubrey Powell / Jen Boorer |
Tel:
+44 (0)20 7496 3000 |
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MacDougall Biomedical Communications(US media
contact)Chris Erdman |
Tel: +1 781
235 3060 cerdman@macbiocom.com |
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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 |
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Forward Looking StatementsThis announcement
contains "forward-looking statements", including, but not limited
to, statements about the discovery, development and
commercialisation of programme assets. These forward-looking
statements are statements based on the Company’s current
intentions, beliefs and expectations, which include, among other
things, the Company’s results of operations, financial condition,
prospects, growth, strategies and the industry in which the Company
operates. No forward-looking statement is a guarantee of future
performance and actual results could differ materially from those
expressed or implied in the forward-looking statements.
Accordingly, readers should not place undue reliance on
forward-looking statements or information. Forward-looking
statements and information by their nature involve known and
unknown risks, uncertainties and other factors which may cause
actual results, performance or achievements, or industry results,
to be materially different from any future results, performance or
achievements expressed or implied by such forward-looking
statements or information. These include but are not limited to:
adverse results in clinical or preclinical development studies;
delays in obtaining regulatory approval; failure to obtain patent
protection for inventions; commercial limitations imposed by
patents owned or controlled by third parties; being unable to
secure partnership agreements to develop and commercialise
programme assets; being unable to secure the necessary funding to
conduct any proposed research and development studies; and the
ability to retain and recruit key personnel. The Company
expressly disclaims any obligation or undertaking to release
publicly any updates or revisions to any forward-looking statement
contained in this announcement to reflect any changes in
expectations with regard thereto or any changes in events,
conditions or circumstances on which any such statement is based,
except as required by applicable law.
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