Summit Therapeutics Reports New Data from Phase 2 Clinical Trial Connecting Ridinilazole’s Microbiome Preservation to Impro...
07 Octobre 2019 - 1:00PM
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, www.summitplc.com.
About C.
difficile InfectionC. 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 RidinilazoleRidinilazole
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 |
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Glyn Edwards / Richard Pye (UK office) |
Tel: |
44 (0)1235 443 951 |
Michelle Avery (US office) |
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+1 617 225 4455 |
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Cairn Financial Advisers LLP (Nominated
Adviser) |
Tel: |
+44 (0)20 7213 0880 |
Liam Murray / Tony Rawlinson |
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|
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N+1 Singer (Joint Broker) |
Tel: |
+44 (0)20 7496 3000 |
Aubrey Powell / Jen Boorer, Corporate FinanceTom Salvesen,
Corporate Broking |
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Bryan Garnier & Co Limited (Joint Broker) |
Tel: |
+44 (0)20 7332 2500 |
Phil Walker / Dominic Wilson |
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MSL Group (US) |
Tel: |
+1 781 684 6652 |
Erin Anthoine |
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summit@mslgroup.com |
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Consilium Strategic Communications (UK) |
Tel: |
+44 (0)20 3709 5700 |
Mary-Jane Elliott / Sue Stuart / Sukaina Virji |
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summit@consilium-comms.com |
Lindsey Neville |
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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-
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