Summit Therapeutics plc Summit Outline Phase 3 Programme For Novel Cdi Antibiotic Ridinilazole
01 February 2017 - 11:00PM
UK Regulatory
TIDMSUMM
Summit Therapeutics plc
('Summit', the 'Company' or the 'Group')
SUMMIT OUTLINES PHASE 3 PROGRAMME FOR NOVEL CDI ANTIBIOTIC RIDINILAZOLE
FOLLOWING FDA AND EMA REGULATORY MEETINGS
Oxford, UK, 1 February 2017 - Summit Therapeutics plc (AIM: SUMM,
NASDAQ: SMMT), the drug discovery and development company advancing
therapies for Duchenne muscular dystrophy and C. difficile infection
('CDI'), today outlines its Phase 3 programme for its novel antibiotic,
ridinilazole, following recent regulatory meetings with the US Food and
Drug Administration ('FDA') and European Medicines Agency ('EMA'). With
input from the FDA and EMA, Summit intends to design the Phase 3
clinical programme to evaluate superiority of ridinilazole over standard
of care in the treatment of CDI. A positive Phase 3 result on
superiority has the potential to support the commercial launch of
ridinilazole as a differentiated therapy that can both treat initial CDI
and reduce disease recurrence.
Mr Glyn Edwards, Chief Executive Officer of Summit commented: "The
constructive end of Phase 2 meetings with the US and European regulators
have enabled us to design a Phase 3 programme that focuses on evaluating
ridinilazole's superiority over standard of care. This is something we
believe would help differentiate our novel class antibiotic from
currently marketed CDI treatments and those in late-stage development.
Superiority in the combined measure of treatment of initial infection
and importantly, reduction in recurrence, could position ridinilazole
for front-line treatment of CDI."
Summit discussed its Phase 3 development programme with the FDA at an
End of Phase 2 meeting and through a scientific advice process with EMA.
With input from both agencies, the Phase 3 programme is expected to
include two trials evaluating ridinilazole as compared to the standard
of care, vancomycin, each of which would enrol approximately 700
patients with CDI with the primary endpoint being superiority in
sustained clinical response ('SCR'). Other planned endpoints will
include health economic outcome measures. The Phase 3 trial designs are
consistent with the successful proof of concept Phase 2 trial, CoDIFy,
in which ridinilazole achieved statistical superiority over vancomycin
in SCR. SCR is a combined endpoint that measures cure at the end of
treatment and a lack of recurrence in the 30 days after treatment. FDA
also confirmed that ridinilazole would be eligible for Priority Review
based on its QIDP designation.
Mr Edwards continued: "As we continue to evaluate our options to
maximise the value of ridinilazole, our stronger financial position
following the DMD programme partnership with Sarepta Therapeutics, Inc.
means Summit has more time to fully explore all options. These include
potentially entering into a collaboration with a third party or securing
meaningful non-dilutive funding from government and charitable
organisations. In parallel, activities to prepare ridinilazole for Phase
3 trials continue with these anticipated to start in the first half of
2018."
About C. difficile Infection
C. difficile infection is a serious healthcare threat in hospitals,
long-term care homes and increasingly the wider community with over one
million estimated cases of CDI each year in the United States and
Europe. It 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, and these cause
further damage to the gut flora and are associated with high rates of
recurrent disease. Recurrent disease is the key clinical issue 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 Ridinilazole
Ridinilazole is an orally administered small molecule antibiotic that
Summit is developing specifically for the treatment of CDI. In
preclinical efficacy studies, ridinilazole exhibited a narrow spectrum
of activity and had a potent bactericidal effect against all clinical
isolates of C. difficile tested. 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 this 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 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 an extension of marketing exclusivity for an
additional five years upon FDA approval.
About Summit Therapeutics
Summit is a biopharmaceutical company focused on the discovery,
development and commercialization of novel medicines for indications for
which there are no existing or only inadequate therapies. Summit is
conducting clinical programs focused on the genetic disease Duchenne
muscular dystrophy and the infectious disease C. difficile infection.
Further information is available at www.summitplc.com and Summit can be
followed on Twitter (@summitplc https://twitter.com/Summitplc ).
For more information, please contact:
Summit Therapeutics
Glyn Edwards / Richard Pye (UK office) Tel: +44 (0)1235 443 951
Erik Ostrowski / 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
(Broker) Tel: +44 (0)20 7496 3000
Aubrey Powell / Lauren Kettle
MacDougall Biomedical Communications
(US media contact) Tel: +1 781 235 3060
Chris Erdman / Karen Sharma cerdman@macbiocom.com ksharma@macbiocom.com
Consilium Strategic Communications
(Financial public relations, UK) Tel: +44 (0)20 3709 5700
Mary-Jane Elliott / Sue Stuart / summit@consilium-comms.com
Jessica Hodgson / Lindsey Neville
Forward Looking Statements
Any statements in this press release about our future expectations,
plans and prospects, including statements about development and
potential commercialisation of our product candidates, the therapeutic
potential of our product candidates, the timing of initiation,
completion and availability of data from clinical trials, the potential
benefits and future operation of the collaboration with Sarepta
Therapeutics Inc., including any potential future payments thereunder,
any other potential third-party collaborations and expectations
regarding the sufficiency of our cash balance to fund operating expenses
and capital expenditures, 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 will be indicative of the results of later clinical trials,
expectations for regulatory approvals, availability of funding
sufficient for our foreseeable and unforeseeable operating expenses and
capital expenditure requirements and other factors discussed in the
"Risk Factors" section of filings that we make with the Securities and
Exchange Commission, including our Annual Report on Form 20-F for the
fiscal year ended 31 January 2016. In addition, any forward-looking
statements included in this press release represent our views only as of
the date of this release and should not be relied upon as representing
our views as of any subsequent date. We specifically disclaim any
obligation to update any forward-looking statements included in this
press release.
This announcement contains inside information for the purposes of
Article 7 of EU Regulation 596/2014 (MAR).
- END -
This announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the information
contained therein.
Source: Summit Therapeutics plc via Globenewswire
http://www.summitplc.com/
(END) Dow Jones Newswires
February 01, 2017 07:00 ET (12:00 GMT)
Copyright (c) 2017 Dow Jones & Company, Inc.
Summit Therapeutics (LSE:SUMM)
Historical Stock Chart
From Apr 2024 to May 2024
Summit Therapeutics (LSE:SUMM)
Historical Stock Chart
From May 2023 to May 2024