Summit Therapeutics plc (‘Summit’ or the
‘Company’)
Summit Therapeutics Reports Ridinilazole Significantly
Improved Short and Longer-Term Quality of Life Measures in Patients
with C. difficile Infection Compared to Standard of
Care
- Statistically Significant Improvements in Physical and
Mental Health Measures
- Benefit of Ridinilazole Treatment Seen as Early as Day
Five
- Data from Phase 2 Clinical Trial Presented at ID Week
2019
Oxford, UK, and Cambridge, MA, US, 3
October 2019 – Summit Therapeutics plc (NASDAQ: SMMT, AIM:
SUMM) today announced that it presented results from the Phase 2
clinical trial of ridinilazole in C. difficile infection (‘CDI’)
detailing improvements in patient quality of life following
antibiotic treatment for CDI. These results were presented in a
poster session at ID Week 2019 being held in Washington, DC between
2-6 October.
“CDI is debilitating for patients, both
physically and mentally. Our Phase 2 clinical trial documented
significant early and longer-term improvements in patient quality
of life over the current standard of care,” commented Dr
David Roblin, President of R&D of Summit. “These
findings suggest the benefits of treatment with ridinilazole goes
beyond the clinical benefits seen in the Phase 2 clinical trial,
with our precision antibiotic also improving the overall wellbeing
of the patient.”
The Phase 2 clinical trial called CoDIFy evaluated ridinilazole
compared to vancomycin in 100 patients with CDI. As part of the
trial, patients completed the EuroQol 5-Dimension questionnaire
three level version (EQ-5D-3L) at baseline, day 5, 10, 12 (test of
clinical cure at end of treatment) and 40 (test of sustained
clinical response). The EQ-5D-3L is a standard measure of health
status which evaluates five dimensions: mobility, self-care, usual
activities, pain/discomfort and anxiety/depression.
“The patient is at the centre of our drug
development universe. Global regulatory authorities and payors
recognise that the value of treatments encompasses more than just
clinical results and are placing increasing importance on patient
reported outcomes, such as the EQ-5D index, in assessing new
therapies,” said Dr Daniel Elger, Chief Commercial
Officer. “We are highly encouraged by the early and
significant changes seen in the Phase 2 trial for patients on
ridinilazole compared to the current standard of care, vancomycin,
and look forward to the data from patient reported outcomes in our
ongoing Phase 3 clinical trials of ridinilazole.”
Overall, fewer patients treated with ridinilazole than patients
treated with vancomycin reported any problems over the time points
in four of the five domains: mobility, self-care, usual activities
and pain/discomfort. Patients in both arms reported problems with
anxiety and depression at baseline, however, the number of patients
treated with ridinilazole reporting problems in this measure
decreased throughout the timepoints. In contrast, the number of
patients treated with vancomycin reporting problems with anxiety
and depression increased at Day ten and remained high through the
end of the study. By Day 40, patients treated with ridinilazole had
improved significantly more than vancomycin in anxiety and
depression. As early as Day five, patients treated with
ridinilazole reported significant improvements in index scores
(p=0.008), a measure which combines scores from the five domains,
and visual analogue scale (VAS) scores (p=0.01), which is a
self-reported score of overall health. While both treatment arms
showed significant improvements in pain and discomfort with
treatment, by Day ten, numerically fewer patients treated with
ridinilazole reported issues than those treated with vancomycin.
These results, along with the statistical superiority achieved in
the primary clinical endpoint of sustained clinical response,
support the continued development of ridinilazole.
A copy of the presentation is 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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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 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-
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