Summit Therapeutics plc Summit Completes Initial 24 Weeks Of Dosing Of Ezutromid In Patients With Dmd In Phaseout Dmd Clinica...

 
TIDMSUMM 
 
   Summit Therapeutics plc 
 
   ("Summit" or the "Company") 
 
   SUMMIT COMPLETES INITIAL 24 WEEKS OF DOSING OF EZUTROMID IN PATIENTS 
WITH DMD IN PhaseOut DMD CLINICAL TRIAL 
 
 
   -- Summit Continues to Expect 24-week Data Q1 2018, which Could Provide 
      Potential Proof of Mechanism for Ezutromid 
 
 
   Oxford, UK, 20 November 2017 - Summit Therapeutics plc (NASDAQ: SMMT, 
AIM: SUMM) the drug discovery and development company advancing 
therapies for Duchenne muscular dystrophy ('DMD') and Clostridium 
difficile infection, announces the completion of the initial 24-weeks of 
dosing of ezutromid in patients with DMD in the Company's Phase 2 
clinical trial called PhaseOut DMD. With the achievement of this 
milestone, Summit continues to expect to report results from this 
initial 24-week dosing period in the first quarter of 2018. 
 
   The 24-week results are expected to include data from muscle biopsies, 
MRI and functional tests, as well as safety data. 
 
   "With the completion of the 24-week dosing period, we remain on-track to 
conduct the planned biopsy, MRI and functional analyses and deliver the 
results for the initial dosing period during the first quarter of 2018," 
commented Dr David Roblin, Chief Operating Officer and Medical Officer 
of Summit. "In the interim data readout, we aim to show a positive 
change following ezutromid treatment in muscle structure and health 
through the evaluation of muscle biopsies. This could potentially 
provide the first evidence of proof of mechanism for utrophin modulators 
in patients and give hope to those living with DMD." 
 
   PhaseOut DMD is a 48-week open-label Phase 2 clinical trial that has 
enrolled 40 patients at sites in the UK and the US. The trial aims to 
establish proof of concept of ezutromid and is evaluating a range of 
muscle structure, muscle health and functional endpoints. As part of the 
trial, each patient has two muscle biopsies taken; a baseline biopsy on 
enrolment and a second either after 24 weeks or 48 weeks of dosing. 
Top-line data from the complete 48-week trial are expected in the third 
quarter of 2018. Following the 48 weeks of treatment, patients have the 
option to continue onto an extension phase. The extension phase will be 
used to gather long term safety and efficacy data and is expected to 
last until ezutromid either receives marketing approval in the relevant 
country or its development is discontinued. 
 
   About Utrophin Modulation in DMD 
 
   DMD is a progressive muscle wasting disease that affects around 50,000 
boys and young men in the developed world. The disease is caused by 
different genetic faults in the gene that encodes dystrophin, a protein 
that is essential for the healthy function of all muscles. There is 
currently no cure for DMD and life expectancy is into the late twenties. 
Utrophin protein is functionally and structurally similar to dystrophin. 
In preclinical studies, the continued expression of utrophin had a 
meaningful, positive effect on muscle performance. Summit believes that 
utrophin modulation has the potential to slow down or even stop the 
progression of DMD, regardless of the underlying dystrophin gene 
mutation. Summit also believes that utrophin modulation could 
potentially be complementary to other therapeutic approaches for DMD. 
The Company's lead utrophin modulator, ezutromid, is an orally 
administered, small molecule drug. DMD is an orphan disease, and the US 
Food and Drug Administration ('FDA') and the European Medicines Agency 
have granted orphan drug status to ezutromid. Orphan drugs receive a 
number of benefits including additional regulatory support and a period 
of market exclusivity following approval. In addition, ezutromid has 
been granted Fast Track designation and Rare Pediatric Disease 
designation by the FDA. 
 
   About Summit Therapeutics 
 
   Summit is a biopharmaceutical company focused on the discovery, 
development and commercialisation of novel medicines for indications for 
which there are no existing or only inadequate therapies. Summit is 
conducting clinical programmes 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). 
 
   Contacts 
 
 
 
 
Summit 
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 (Joint Broker)                     Tel:         [phone] 
Aubrey Powell / Jen Boorer 
 
Pamure Gordon (Joint Broker)                  Tel:         [phone] 
Freddy Crossley / Duncan Monteith, 
Corporate Finance 
Tom Salvesen, Corporate Broking 
 
MacDougall Biomedical Communications (US)     Tel:             [phone] 
Karen Sharma                                             [e-mail] 
 
Consilium Strategic Communications (UK)       Tel:         [phone] 
Mary-Jane Elliott / Sue Stuart /                    [e-mail] 
Jessica Hodgson / Philippa Gardner 
 
   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 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 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 2017. 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. 
 
   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

November 20, 2017 07:00 ET (12:00 GMT)

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