Summit Therapeutics plc Summit Outline Phase 3 Programme For Novel Cdi Antibiotic Ridinilazole

 
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: [phone] 
 Erik Ostrowski / Michelle Avery (US office)    [phone] 
Cairn Financial Advisers LLP 
 (Nominated Adviser)                            Tel: [phone] 
 Liam Murray / Tony Rawlinson 
N+1 Singer 
 (Broker)                                       Tel: [phone] 
 Aubrey Powell / Lauren Kettle 
MacDougall Biomedical Communications 
 (US media contact)                            Tel: [phone] 
 Chris Erdman / Karen Sharma                   [e-mail] [e-mail] 
Consilium Strategic Communications 
 (Financial public relations, UK)              Tel: [phone] 
 Mary-Jane Elliott / Sue Stuart /              [e-mail] 
 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 - 
 
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   The issuer of this announcement warrants that they are solely 
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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)

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