Summit Presents New Data from Phase 1b Clinical Trial of SMT C1100 for Treatment of DMD

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July 07, 2014 02:00 ET

Summit Therapeutics plc

Summit Therapeutics plc

Summit Corporation plc

('Summit' or the 'Company')

SUMMIT PRESENTS NEW DATA FROM PHASE 1B CLINICAL TRIAL OF SMT C1100 FOR TREATMENT OF DMD AT INTERNATIONAL CONFERENCE

Reduction observed in enzyme levels associated with muscle damage

Oxford, UK, 7 July 2014 - Summit (AIM: SUMM), a drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy ('DMD') and C. difficile infection, reports new data from its recently completed Phase 1b clinical trial of the utrophin modulator SMT C1100 for the treatment of DMD.  These data are being reported at the 13th International Congress on Neuromuscular Diseases ('ICNMD') being held between 5-10 July in Nice, France.  The results of this study showed a statistically significant decrease in key enzymes associated with muscle damage and support the proposed mechanism of action of SMT C1100.

"These new data from the Phase 1b clinical trial of SMT C1100 provide further encouragement regarding the potential of our utrophin modulator as a disease modifying treatment for all patients with DMD," commented Glyn Edwards, Chief Executive Officer of Summit.  "The reduction during drug dosing in enzyme markers normally associated with muscle damage provides an intriguing indication of SMT C1100 activity in these patients. We look forward to progressing SMT C1100 into future trials."

The new data reports the impact of dosing with SMT C1100 on blood levels of the enzymes creatine kinase ('CK'), aspartate aminotransferase ('AST') and alanine aminotransferase ('ALT').  The levels of these enzymes are normally very low in healthy people but in patients with DMD, muscle cells are weakened by the lack of dystrophin causing these enzymes to leak out and accumulate in the blood.  During dosing with SMT C1100, a statistically significant reduction in CK, AST and ALT levels was observed when compared to pre-dose baseline levels.  Blood levels of these enzymes increased towards pre-dosing levels after dosing stopped.

These data are consistent with the proposed mechanism of action of the utrophin modulator SMT C1100, whereby its effect would result in lower muscle damage and lead to lower levels of these key markers in the blood.  The data from this Phase 1 study are encouraging and clearly support further evaluation in a placebo-controlled study.

A poster presentation reporting these additional findings from the Phase 1b clinical trial will be presented at ICNMD at 11:30am CET on Monday 7 July 2014.  A second presentation describing significant advances in the development of new biomarkers for use in future DMD patient clinical trials will be made at the conference at 11:30am CET on 10 July 2014.  Further details are provided below and copies will be made available from www.summitplc.com on the day of the respective presentation.

Utrophin modulators to treat Duchenne Muscular Dystrophy (DMD): Phase 1b clinical trial results of SMT C1100

Francesco Muntoni, Stefan Spinty, Helen Roper, Imelda Hughes, Valeria Ricotti, Alison Bracchi, Bina Tejura, David Roblin, Kay Davies, Jon Tinsley (Poster session: PS1-72 / #298)

Development of a multifaceted biomarker strategy to support clinical development of utrophin modulators for Duchenne muscular dystrophy (DMD) therapy

Jonathon Tinsley, Francis X. Wilson, Narinder Janghra, Jennifer Morgan, Caroline Sewry, Francesco Muntoni, Kay E. Davies (Poster session: PS4-437 / #296)

This presentation reports data from the biomarkers being developed to measure utrophin protein levels and quantify levels of muscle regeneration and fibrosis.  This work has been supported in part by grant funding from the DMD organisations Joining Jack and the Foundation to Eradicate Duchenne.

Summit is an Oxford, UK based drug discovery and development company targeting high-value areas of unmet medical need including Duchenne Muscular Dystrophy and C. difficile infection. Summit is quoted on the AIM market of the London Stock Exchange and trades under the ticker symbol SUMM. Further information is available at www.summitplc.com and Summit can be followed on Twitter (@summitplc).

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Forward Looking Statements

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