Summit Therapeutics plc Summit Presents New 24-Week Analyses From Phaseout Dmd At The 2018 Aan Conference

 
TIDMSUMM 
 
   Summit Therapeutics plc 
 
   ('Summit', or 'the Company') 
 
   Summit Presents New 24-Week Analyses from PhaseOut DMD at the 2018 
American Academy of Neurology Annual Meeting 
 
 
   -- Data show correlation between decrease in muscle damage and reduction in 
      muscle inflammation in patients treated with ezutromid 
 
 
   Oxford, UK, and Cambridge, MA, US, 20 April 2018 - Summit Therapeutics 
plc (NASDAQ:SMMT, AIM:SUMM) announces the presentation of new 24-week 
interim analyses from PhaseOut DMD, a Phase 2 open-label, multi-centre 
clinical trial of the utrophin modulator ezutromid in Duchenne muscular 
dystrophy ('DMD'), at the 70(th) American Academy of Neurology Annual 
Meeting ('AAN'). These new analyses showed a high correlation between 
reductions in developmental myosin, a biomarker of muscle damage which 
was measured by muscle biopsy, and reductions in muscle inflammation, 
which was measured by magnetic resonance, in patients after 24 weeks of 
ezutromid treatment. These findings underpin existing evidence that by 
modulating utrophin protein production, ezutromid is reducing the 
severity of DMD. 
 
   "The correlation observed between decreases in developmental myosin, a 
biomarker of muscle damage, and decreases in muscle fibre inflammation, 
is highly encouraging, and we believe further supports that ezutromid is 
breaking the DMD disease cycle of muscle damage and repair," commented 
Dr David Roblin, Chief Medical Officer and President of R&D of Summit. 
"We look forward to reporting the full results of this trial, expected 
in the third quarter of 2018." 
 
   The presentation was selected for the Emerging Science dual oral and 
poster presentation at AAN and authored by Professor Francesco Muntoni 
on behalf of the PhaseOut DMD Study Group, Gary Layton, Indranil 
Bhattacharya, Crystal Faelan, Anne C Heatherington, David Roblin, Jon 
Tinsley, and Professor Kay E Davies. A copy of the late-breaking 
presentation is available on Summit's website, www.summitplc.com. 
 
   About PhaseOut DMD 
 
   PhaseOut DMD is an open-label, multi-centre trial that has enrolled 40 
patients in the US and UK, aged from their fifth to their tenth 
birthdays. PhaseOut DMD is 48 weeks in length after which patients have 
the option of enrolling into an extension phase and continuing to be 
dosed with ezutromid. The primary endpoint is the change from baseline 
in magnetic resonance parameters related to the leg muscles. Biopsy 
measures evaluating utrophin and muscle damage are included as secondary 
endpoints, with patients having two biopsies: one at baseline and their 
second after either 24 weeks or 48 weeks of ezutromid treatment. 
Exploratory endpoints include the six-minute walk distance, the North 
Star Ambulatory Assessment and patient reported outcomes. Top-line 
48-week results are expected to be reported in the third quarter of 
2018. 
 
   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 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). 
 
   For more information, please contact: 
 
 
 
 
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 
 
Panmure Gordon (Joint Broker)                Tel:          [phone] 
Freddy Crossley, 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 / Jessica Hodgson /               [e-mail] 
Philippa Gardner 
 
   Forward-looking Statements 
 
   Any statements in this press release about Summit's future expectations, 
plans and prospects, including but not limited to, statements about the 
clinical and preclinical development of Summit's product candidates, the 
therapeutic potential of Summit's product candidates, the timing of 
initiation, completion and availability of data from clinical trials, 
the potential submission of applications for regulatory approvals, the 
sufficiency of Summit's cash resources, 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, availability of 
funding sufficient for Summit's foreseeable and unforeseeable operating 
expenses and capital expenditure requirements and other factors 
discussed in the "Risk Factors" section of filings that Summit makes 
with the Securities and Exchange Commission including Summit's Annual 
Report on Form 20-F for the fiscal year ended January 31, 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 Summit's views only as of the 
date of this release and should not be relied upon as representing 
Summit's views as of any subsequent date. Summit specifically disclaims 
any obligation to update any forward-looking statements included in this 
press release. 
 
   -END- 
 
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   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

April 20, 2018 07:00 ET (11:00 GMT)

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