Increased BARDA Award and Option Exercise
June 18 2019 - 6:00AM
Summit Therapeutics plc (‘Summit’ or the
‘Company’)
Summit Announces BARDA Increases Award for Ridinilazole
Clinical and Regulatory Development to up to $63.7 Million and
Exercises Next Contract Option
- Summit Awarded $9.6M under Next Contract
Option
- Total Committed BARDA Funding Now $53.6
Million
Oxford, UK, and Cambridge, MA, US, 18
June 2019 – Summit Therapeutics plc (NASDAQ: SMMT, AIM:
SUMM), a leader in new mechanism antibiotic innovation, today
announces that the Biomedical Advanced Research and Development
Authority (‘BARDA’) has increased the total value of its award for
the clinical and regulatory development of Summit’s precision
antibiotic ridinilazole for the treatment of C. difficile infection
(‘CDI’) to up to $63.7 million. Under this award, BARDA has opted
to exercise the next contract option for $9.6 million, which will
support patient enrolment and dosing in the ongoing Phase 3
clinical trials of ridinilazole.
“The funding from BARDA is a testament to the
promise of ridinilazole to address an important public health need
in CDI. Through our ongoing landmark Phase 3 clinical programme, we
aim to show that our microbiome preserving antibiotic is superior
in sustaining cures compared to the current standard of care and so
has the potential to be the front-line treatment option for
patients with CDI,” said Mr Glyn Edwards, Chief Executive
Officer of Summit. “We are pleased with the excellent
working relationship that has been formed between us over the last
two years and thank BARDA for its continuing support of
ridinilazole.”
The total committed funding from the BARDA award
under Contract No. HHS0100201700014C is now $53.6 million, with one
final option remaining. The final option provides funding support
for potential applications for marketing approvals of ridinilazole.
The BARDA contract provides for a cost-sharing arrangement with the
committed funding drawn down over a specified development
period.
This announcement contains inside information
for the purposes of Article 7 of EU Regulation 596/2014 (MAR).
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 the Contract with
BARDAThis project has been funded in whole or in part with
federal funds from the Biomedical Advanced Research and Development
Authority, a component of the Office of the Assistant Secretary for
Preparedness and Response within the U.S. Department of Health and
Human Services, under contract number HHS0100201700014C.
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 FinanceTom 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 6557 |
Jon Siegal |
|
summit@mslgroup.com |
|
|
|
Consilium Strategic Communications (UK) |
Tel: |
+44 (0)20 3709 5700 |
Mary-Jane Elliott / Sue Stuart / |
|
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-
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