Summit Therapeutics plc Summit Enrolls Patients In The Us Into Phaseout Dmd, A Phase 2 Clinical Trial Of Ezutromid

 
TIDMSUMM 
 
 
   Summit Therapeutics plc 
 
   ("Summit" or "the Company") 
 
   SUMMIT ENROLS PATIENTS IN THE UNITED STATES INTO PhaseOut DMD, A PHASE 2 
CLINICAL TRIAL OF EZUTROMID IN PATIENTS WITH DMD 
 
   Oxford, UK, 16 November 2016 - Summit Therapeutics plc (NASDAQ: SMMT, 
AIM: SUMM), the drug discovery and development company advancing 
therapies for Duchenne muscular dystrophy ('DMD') and Clostridium 
difficile infection, today announces that it has enrolled its first 
patients at trial sites in the US into PhaseOut DMD, a Phase 2 proof of 
concept clinical trial of ezutromid in patients with DMD. Ezutromid 
dosing is expected to follow within a screening period of up to 28 days. 
Enrolment and dosing of patients into PhaseOut DMD in the UK is ongoing. 
Ezutromid is a utrophin modulator and represents a potential disease 
modifying treatment for all patients with DMD. 
 
   "Ezutromid has shown great promise in preclinical testing as a universal 
treatment that has the potential to slow or stop disease progression in 
all patients with DMD, regardless of their underlying dystrophin gene 
mutation," said John Jefferies, MD, of Cincinnati Children's Hospital 
Medical Center, and the US coordinating investigator in PhaseOut DMD. 
"We are excited to participate in PhaseOut DMD and contribute to the 
clinical development of this utrophin modulator." 
 
   Ralf Rosskamp, MD, Chief Medical Officer of Summit added, "Our PhaseOut 
DMD clinical trial is an important component of bringing ezutromid to 
patients and families who are in urgent need of a disease modifying 
therapy, and we are making progress with patient enrolment in this 
clinical trial, with enrolment ongoing in the UK and now in the US." 
 
   This announcement contains inside information for the purposes of 
Article 7 of EU Regulation 596/2014 (MAR). 
 
   About PhaseOut DMD 
 
   PhaseOut DMD aims to provide proof of concept for ezutromid and utrophin 
modulation by measuring muscle fat infiltration, as well as by measuring 
utrophin protein and muscle fibre regeneration in muscle biopsies. The 
primary endpoint of the open-label trial is the change from baseline in 
magnetic resonance imaging parameters related to fat infiltration and 
inflammation of the leg muscles. Exploratory endpoints include the 
six-minute walk distance, the North Star Ambulatory Assessment and 
patient reported outcomes. PhaseOut DMD is a 48-week open-label trial 
expected to enrol up to 40 boys ranging in age from their fifth to their 
tenth birthdays at sites in the UK and the US. Each patient will receive 
two biopsies, one at baseline and the second either at 24 or 48 weeks. 
Data from the initial group of 24-week biopsies are expected Q2/Q3 2017. 
 
   Further information is available at: 
https://clinicaltrials.gov/ct2/show/NCT02858362 and 
www.utrophintrials.com. 
 
   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 has 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. 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 
 (Broker)                                       Tel: [phone] 
 Aubrey Powell / Jen Boorer 
MacDougall Biomedical Communications 
 (US media contact)                            Tel: [phone] 
 Chris Erdman / Karen Sharma                   [e-mail] 
                                               [e-mail] 
Consilium Strategic Communications            Tel: [phone] 
 (Financial public relations, UK)              [e-mail] 
 Mary-Jane Elliott / Sue Stuart / 
 Jessica Hodgson / Lindsey Neville 
 
 
 
   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, and the timing of 
initiation, completion and availability of data from clinical trials, 
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 on-going 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, 2016. 
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- 
 
   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 16, 2016 07:00 ET (12:00 GMT)

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