Summit Therapeutics plc Summit Therapeutics Reports New Data From Phase 2 Clinical Trial Connecting Ridinilazole's Microbiome...

TIDMSUMM

Summit Therapeutics plc

('Summit' or the 'Company')

Summit Therapeutics Reports New Data from Phase 2 Clinical Trial
Connecting Ridinilazole's Microbiome Preservation to Improved Clinical
Outcomes for Patients with C. difficile Infection

-- Data Presented at ID Week 2019

Oxford, UK, and Cambridge, MA, US, 7 October 2019 -- Summit Therapeutics
plc (NASDAQ: SMMT, AIM: SUMM) today announced the presentation of new
data that explain the link between two key findings in the Company's
Phase 2 clinical trial of ridinilazole for C. difficile infection
('CDI'):

-- Ridinilazole demonstrated superior efficacy compared to vancomycin,
driven by a 60% lower recurrence rate.

-- Ridinilazole preserved the diversity of the gut microbiome.

Researchers at Tufts University, collaborating with Summit, showed that
these findings are connected mechanistically by bile acids, part of the
'metabolome' of active chemicals made or modified by gut bacteria. Bile
acids exist in different forms that can either favour or block the
regrowth of C. difficile after treatment. Vancomycin kills bacteria that
turn pro-C. difficile bile acids into anti-C. difficile bile acids --
leaving an adverse ratio of pro- and anti-growth chemicals that favours
the regrowth of C. difficile and the recurrence of C. difficile
infection. By contrast, ridinilazole leaves these bacteria unharmed,
allowing them to keep converting pro-C. difficile bile acids into
anti-C. difficile bile acids, maintaining a positive chemical balance
that prevents C. difficile recurrence.

"The damaging effect of broad-spectrum antibiotics in the treatment of
CDI is far-reaching from the make-up and function of the gut microbiome
through the poor clinical outcomes seen in one third of patients, driven
by a high rate of disease recurrence," said Dr David Roblin, President
of R&D of Summit. "Ridinilazole has the potential to be a targeted CDI
treatment that could result in significantly better patient outcomes for
the over half million US patients per year who have an episode of CDI.
These latest data help to put the science behind the function of a
healthy microbiome into context and highlight its importance in
sustaining CDI cures."

The Phase 2 clinical trial enrolled 100 patients, half of whom received
ridinilazole and the other half vancomycin. For both groups, there was a
higher ratio of pro-C. difficile to anti C.-difficile bile acids at the
start of treatment. This was expected, as patients who get CDI have
perturbed microbiomes. However, during treatment, the proportion of
anti-C. difficile bile acids increased in patients treated with
ridinilazole, whereas patients treated with vancomycin initially showed
decreases in anti-C. difficile bile acids and had stools dominated by
pro-C. difficile bile acids. By the end of treatment,
ridinilazole-treated patients' bile acid ratios returned towards a
healthy, non-CDI state. These results support the data from the Phase 2
clinical trial, in which patients receiving ridinilazole showed a
statistically significant improvement in sustained clinical responses.

Copies of the two poster presentations are available in the Publications
section of Summit's website,
https://www.globenewswire.com/Tracker?data=1-ujmlz_AfYU4dN0w3FcC7e8IKaED85-OxxxSmLpKkNWooHrRFd6rqws_l_j44u8VtP_pSU8N2-L-OtrCWlv6_afyg9SR0MHxj4QOmKUgjY=
www.summitplc.com.

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 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 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
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 potential benefits and future operation of the
BARDA contract, including any potential future payments thereunder, 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 ability of BARDA to
terminate our contract for convenience at any time, 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

October 07, 2019 07:00 ET (11:00 GMT)

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