Phase 2 Clinical Data Published Showing Summit’s Ridinilazole Preserved the Gut Microbiome of Patients with C. difficile In...
August 02 2018 - 1:00PM
Summit Therapeutics plc (NASDAQ: SMMT, AIM: SUMM) announces today
the publication in the journal PLOS ONE of microbiome analyses
highlighting ridinilazole as a precision antibiotic in development
for the treatment of C. difficile infection (‘CDI’).
The clinical management of CDI is stymied by
poor sustained cures due to high recurrence rates after initial
infection. The microbiome is known to play an important role in
protecting against initial CDI and the onset of recurrent disease.
Thus, preserving the microbiome could help to address the key unmet
need in CDI. In a double-blind Phase 2 clinical trial, ridinilazole
was highly preserving of patients’ microbiomes compared to patients
treated with the broad-spectrum standard of care antibiotic
vancomycin. With this microbiome preservation, ridinilazole
treatment resulted in a 59% reduction in recurrence compared to
vancomycin (14.3% vs. 34.8%, respectively). Ridinilazole also
demonstrated clinical and statistical superiority over vancomycin
in sustained clinical response, which captures whether patients
have been cured and remain free from disease recurrence 30 days
after completing treatment.
“These results show how the precision action of
ridinilazole against C. difficile, and its corresponding lack of
impact on the broader microbiome, led to greatly increased rates of
sustained cures through decreased disease recurrence. Better
prevention of recurrence is the next frontier in CDI therapy, with
potential to reduce both patient morbidity and healthcare costs,
which escalate further when initial treatment fails,”
commented Dr David Roblin, President of R&D of
Summit. “Ridinilazole exemplifies Summit’s strategy of
developing new mechanism antibiotics we believe may have the
potential to become new standards of care for serious bacterial
infections.”
The results published today from the CoDIFy
Phase 2 clinical trial highlighted how ridinilazole had
significantly less impact on the microbiome assessed at a range of
timepoints as compared to vancomycin. In contrast, vancomycin
treatment resulted in microbiome-wide changes that persisted beyond
the end of treatment. Significant differences were also observed in
microbiome health as measured by alpha diversity.
Ridinilazole-treated patients had no significant changes while a
significant loss in alpha diversity was seen in vancomycin-treated
patients (p >0.0001). The microbiome analyses were conducted in
collaboration with Tufts Medical Center.
The publication is available here:
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0199810.
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. Summit is eligible to receive up to $62 million
in funding from BARDA to support the clinical and regulatory
development of ridinilazole. Phase 3 clinical trials are expected
to initiate Q1 2019.
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 gut microbiome and allow
overgrowth of C. difficile bacteria. Existing CDI
treatments are predominantly broad-spectrum antibiotics, which
cause further damage to the microbiome 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 RidinilazoleRidinilazole
is an oral 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 has received
Qualified Infectious Disease Product ('QIDP') designation and has
been granted Fast Track designation and Breakthrough Therapy
designation by the US Food and Drug Administration. The QIDP
incentives are provided through the US GAIN Act and include an
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
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Liam
Murray / Tony Rawlinson |
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N+1 Singer (Joint Broker) |
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Aubrey Powell / Jen Boorer |
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Panmure Gordon (Joint Broker) |
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Freddy Crossley, Corporate Finance |
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James
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MSL Group (US) |
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Jon
Siegal |
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Jon.siegal@mslgroup.com |
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Consilium Strategic Communications (UK) |
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Mary-Jane Elliott / Jessica Hodgson |
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summit@consilium-comms.com |
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Lindsey Neville |
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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
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