Summit Awarded Additional $12 Million by BARDA for Phase 3 Development Programme of Ridinilazole for the Treatment of C. diff...
August 16 2018 - 7:00AM
Summit Therapeutics plc (NASDAQ:SMMT, AIM:SUMM), a leader in
antibiotic innovation, today announces that it has been awarded an
additional $12 million under its contract with the Biomedical
Advanced Research and Development Authority (BARDA), a division of
the U.S. Department of Health and Human Services, Office of the
Assistant Secretary for Preparedness and Response. The funds will
support the Phase 3 development programme for ridinilazole, the
Company’s precision new mechanism antibiotic for the treatment of
C. difficile infection (‘CDI’).
“BARDA’s continued support underlines the
promise ridinilazole has as a potential front-line CDI treatment
option which can treat the initial infection and address the key
clinical issue of recurrent disease,” commented Mr Glyn
Edwards, Chief Executive Officer of Summit. “We look
forward to the planned initiation of the Phase 3 clinical trials
which remains on track for the first quarter of 2019.”
Today’s award represents the first of three
optional awards to be exercised under the BARDA contract. It brings
the total committed BARDA funding to $44 million, which includes
the base package of $32 million announced in September 2017. If
BARDA exercises its remaining options in full, the total funding
under the contract would increase up to $62 million. The $12
million in funding will be drawn down to specifically support drug
manufacturing activities required for the submission of marketing
approval applications and other regulatory activities.
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. Existing CDI
treatments are predominantly 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. 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 a 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, an orally
administered small molecule, 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 TherapeuticsSummit 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.
This announcement contains inside information for the purposes
of Article 7 of EU Regulation 596/2014 (MAR).
Contacts
Summit |
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|
Glyn
Edwards / Richard Pye (UK office) |
Tel: |
44
(0)1235 443 951 |
Erik
Ostrowski / 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 |
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|
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|
Panmure Gordon (Joint Broker) |
Tel: |
+44
(0)20 7886 2500 |
Freddy Crossley, Corporate Finance |
|
|
James
Stearns, Corporate Broking |
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|
|
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|
MSL Group (US) |
Tel: |
+1
617 684 6557 |
Jon
Siegal |
|
Jon.siegal@mslgroup.com |
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|
|
Consilium Strategic Communications (UK) |
Tel: |
+44
(0)20 3709 5700 |
Mary-Jane Elliott / Jessica Hodgson |
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summit@consilium-comms.com |
/
Lindsey Neville |
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Summit Forward-looking StatementsAny 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, 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 2018. 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.
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