Summit Therapeutics plc Summit Recognises C. Difficile Awareness Month
01 November 2018 - 10:00PM
UK Regulatory
TIDMSUMM
Summit Therapeutics plc
('Summit' or the 'Company')
Summit Recognises C. difficile Awareness Month
Oxford, UK, and Cambridge, MA, US, 1 November 2018 -- Summit
Therapeutics plc (NASDAQ: SMMT, AIM: SUMM), a leader in new mechanism
antibiotic innovation, recognises C. difficile Awareness Month, which
highlights the common, but largely unknown C. difficile infection (CDI)
throughout the month of November. C. difficile infects over one million
patients in the US and Europe each year, causing inflammation and severe
diarrhoea that can be fatal. Summit is developing the Phase 3-ready
precision antibiotic ridinilazole to address both the initial infection
and importantly the key unmet need of reducing recurrence of CDI.
As part of CDI Awareness Month, Summit is presenting on ridinilazole and
its Phase 3 clinical trial plans at the 6(th) Annual International C.
diff Conference and Health Expo taking place 8-9 November 2018 in
Philadelphia, PA.
"We lose over 40 patients a day to CDI in the US. The current standard
of care fails to fully address the major burden CDI places on patients,
their families and healthcare systems, and new treatment options are
desperately needed," said Nancy C. Caralla, Founding President and
Executive Director of the C Diff Foundation. "The biggest need in CDI
is reducing recurrence of the disease, as with each CDI episode, we see
increasing severity, morbidity and mortality. A targeted therapy used
upfront could help to reduce recurrence and provide a better overall
outcome for patients. We are excited to see Summit's ridinilazole
advancing into Phase 3 clinical trials."
"The landscape of infectious diseases is shifting towards precision
medicine -- using a specific drug for a specific infection. CDI is a
textbook example whereby broad-spectrum antibiotics exacerbate the
problem both in causing the initial disease and in driving recurrence,"
said Dr David Roblin, President of R&D of Summit. "We believe
ridinilazole has the potential to significantly improve the CDI
landscape as a front-line treatment and look forward to initiating our
planned Phase 3 clinical trials in the first quarter of 2019."
The US Centers for Disease Control and Prevention lists C. difficile as
an urgent public health threat that requires aggressive action. Most
cases of CDI are directly related to prior antibiotic use for unrelated
infections, which damages the gut microbiome that could otherwise
protect against CDI. The current standard of care, vancomycin, is a
broad-spectrum antibiotic, meaning that it indiscriminately kills
bacteria, including the protective bacteria in the gut microbiome, and
leaves patients susceptible to CDI recurrence. Ridinilazole is designed
to selectively kill C. difficile and preserve the protective gut
microbiome to reduce CDI recurrence and sustain cures. These
characteristics were observed in a Phase 2 clinical trial where
ridinilazole demonstrated statistical superiority over vancomycin in
sustained clinical response.
About C. difficile Infection
C. difficile infection is a serious healthcare threat in hospitals,
long-term care homes and increasingly in the wider community with over
one million estimated cases of CDI annually in the United States and
Europe. CDI 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, which cause
further damage to the gut flora and are associated with high rates of
recurrent disease. Reducing disease recurrence is the key clinical issue
in CDI 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 a small molecule antibiotic that Summit is developing
for the treatment of CDI. In preclinical efficacy studies, ridinilazole
exhibited a targeted spectrum of activity that combined a potent
bactericidal effect against all clinical isolates of C. difficile tested
with minimal impact on other bacteria that are typically found in the
gut microbiome. 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
that 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 was
also shown to be highly preserving of the gut microbiome in the Phase 2
proof of concept trial, which was believed to be the reason for the
improved clinical outcome for the ridinilazole-treated patients. In
addition, ridinilazole preserved the gut microbiome to a greater extent
than the marketed narrow-spectrum antibiotic fidaxomicin in an
exploratory Phase 2 clinical trial. Ridinilazole, an orally administered
small molecule, 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 a potential extension of marketing
exclusivity for an additional five years upon FDA approval.
About Summit Therapeutics
Summit Therapeutics is a leader in antibiotic innovation. Our new
mechanism antibiotics are designed to become the new standards of care
for the benefit of patients and create value for payors and healthcare
providers. We are currently developing new mechanism antibiotics for C.
difficile infection and gonorrhoea and are using our proprietary Discuva
Platform to expand our pipeline. For more information, visit
www.summitplc.com and follow us on Twitter @summitplc.
Contacts
Summit
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 (Joint Broker) Tel: +44 (0)20 7496 3000
Aubrey Powell / Jen Boorer, Corporate
Finance
Tom Salvesen, Corporate Broking
Panmure Gordon (Joint Broker) Tel: +44 (0)20 7886 2500
Freddy Crossley, Corporate Finance
James Stearns, Corporate Broking
MSL Group (US) Tel: +1 781 684 6557
mailto:summit@mslgroup.com
Jon Siegal summit@mslgroup.com
---------------------------------
Consilium Strategic Communications
(UK) Tel: +44 (0)20 3709 5700
Mary-Jane Elliott / Jessica Hodgson mailto:summit@consilium-comms.com
/ Sue Stuart / summit@consilium-comms.com
---------------------------------
Lindsey Neville
Summit Forward-looking Statements
Any statements in this press release about the Company's future
expectations, plans and prospects, including but not limited to,
statements about the clinical and preclinical development of the
Company's product candidates, the therapeutic potential of the Company's
product candidates, the potential commercialisation of the Company's
product candidates, the sufficiency of the Company's cash resources, the
timing of initiation, completion and availability of data from clinical
trials, the potential submission of applications for marketing approvals
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 or preclinical
studies will be indicative of the results of later clinical trials,
expectations for regulatory approvals, laws and regulations affecting
government contracts and funding awards, availability of funding
sufficient for the Company's foreseeable and unforeseeable operating
expenses and capital expenditure requirements and other factors
discussed in the "Risk Factors" section of filings that the Company
makes with the Securities and Exchange Commission, including the
Company's Annual Report on Form 20-F for the fiscal year ended 31
January 2018. 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 the
Company's views only as of the date of this release and should not be
relied upon as representing the Company's views as of any subsequent
date. The Company specifically disclaims any obligation to update any
forward-looking statements included in this press release.
-END-
(END) Dow Jones Newswires
November 01, 2018 07:00 ET (11:00 GMT)
Copyright (c) 2018 Dow Jones & Company, Inc.
Summit Therapeutics (LSE:SUMM)
Historical Stock Chart
From Apr 2024 to May 2024
Summit Therapeutics (LSE:SUMM)
Historical Stock Chart
From May 2023 to May 2024