Summit Therapeutics plc Summit Therapeutics Recognisesc. Difficile Awareness Month

TIDMSUMM

Summit Therapeutics plc

('Summit' or the 'Company')

Summit Therapeutics Recognises C. difficile Awareness Month

-- Company to Highlight Potential of Phase 3 Precision Antibiotic
Ridinilazole at the 7th Annual C. diff. Conference and Health EXPO

Oxford, UK, and Cambridge, MA, US, 4 November 2019 -- Summit
Therapeutics plc (NASDAQ: SMMT, AIM: SUMM) recognises C. difficile
Awareness Month. Each year, more than one million patients in the US and
Europe are diagnosed with C. difficile infection ('CDI'), and yet
general awareness of CDI is lacking.

"C. difficile is a common, yet largely unknown infection and its
Awareness Month provides an opportunity to educate on this illness and
bring the focus to the unacceptably high numbers of patients that
current CDI treatments fail. The treatment failures are driven by the
negative impact of current antibiotic treatments on the healthy bacteria
of the gut microbiome," commented Dr David Roblin, President of R&D of
Summit. "By being targeted to C. difficile, our precision antibiotic
ridinilazole has the potential to preserve patients' microbiomes and
improve outcomes for patients with CDI."

As part of its activities for CDI awareness month, Summit will be
presenting at the 7(th) Annual C. diff. Conference and Health EXPO in
St. Louis, Missouri. The presentation will review data from the Phase 2
clinical trial of ridinilazole compared to vancomycin. In this clinical
trial, ridinilazole achieved statistical superiority over vancomycin in
the measure of sustained clinical response ('SCR'), which captured
whether patients were cured of CDI and remained cured for 30 days after
treatment. In addition, an exploratory endpoint in the trial showed
patients treated with ridinilazole had significantly preserved gut
microbiomes compared to vancomycin.

Ridinilazole is currently being evaluated in two global Phase 3 clinical
trials for superiority over vancomycin in SCR. Data are expected from
the trials in the second half of 2021.

For more information on CDI, visit the Peggy Lillis Foundation at
https://www.globenewswire.com/Tracker?data=w6CxG950MmrmUWac6onN4H-fF061UPN6ubrE9Gf0mdtONXPBNTrlM2Sv2UYB797EGdpbqD9iubf-IEOKQoEPQD40uc7ZdGDO2-CdoJT-64U=
www.peggyfoundation.org and
https://www.globenewswire.com/Tracker?data=w6CxG950MmrmUWac6onN4G6LuFOGQvmD84L-UoS_Qznzq1J8PFXLOs4HX-RtLkxCUt4-gnnKja5qMUFc-KqJlQ==
www.cdiff.org, and the C. diff Foundation at
https://www.globenewswire.com/Tracker?data=w6CxG950MmrmUWac6onN4I98OGNOI8-LKdrKfqlhYulGtzT-q7vRap4f1j4c-xIEqe-GJ9u67oV5QFbnj7z3eYTuoigFFH4aF_0fm2njzu0=
www.cdifffoundation.org.

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. The vast majority
of patients are treated with 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. A study estimated
that the total costs attributable to the management of CDI were
approximately $6.3 billion per year in the United States.

About Ridinilazole

Ridinilazole is an oral small molecule new mechanism antibiotic that is
designed to selectively kill C. difficile, thereby preserving patients'
protective gut microbiome and leading to sustained CDI cures. In a Phase
2 proof of concept trial in CDI patients, ridinilazole showed
statistical superiority in sustained clinical response ('SCR') rates
compared to 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 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.

The clinical and regulatory development of ridinilazole is being funded
in part with Federal funds from the US Department of Health and Human
Services, Office of the Assistant Secretary for Preparedness and
Response, Biomedical Advanced Research and Development Authority
('BARDA'), under Contract No. HHS0100201700014C.

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
infections caused by C. difficile, N. gonorrhoeae and Enterobacteriaceae
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
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

Bryan Garnier & Co Limited (Joint Broker) Tel: +44 (0)20 7332 2500
Phil Walker / Dominic Wilson
MSL Group (US) Tel: +1 781 684 6652
mailto:summit@mslgroup.com
Erin Anthoine summit@mslgroup.com
---------------------------------

Consilium Strategic Communications (UK) Tel: +44 (0)20 3709 5700
Mary-Jane Elliott / Sue Stuart / Sukaina mailto:summit@consilium-comms.com
Virji 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 2019. 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 04, 2019 07:00 ET (12:00 GMT)

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