Summit plc Phase 1 Trial Approved


Oxford, UK, 24 April 2012, Summit (AIM: SUMM), a UK drug discovery company, today announces  that its Phase I Clinical Trial Application ('CTA') for SMT C1100 has been approved by the UK  regulatory body, the Medicines and Healthcare products Regulatory Agency ('MHRA'). SMT C1100 is  a small molecule utrophin upregulator that has the potential to be a universal treatment for the fatal  genetic disease Duchenne Muscular Dystrophy ('DMD'). 

The approval of the CTA achieves a milestone as part of the $1.5 million agreement signed between  Summit and a group of US-based DMD organisations in December 2011 and triggers a payment of  $437,500. The Phase I trial is funded by the Muscular Dystrophy Association, Parent Project  Muscular Dystrophy, Charley's Fund, Cure Duchenne, the Foundation to Eradicate Duchenne and the   Nash Avery Foundation.

The double-blind, placebo-controlled Phase I study will be conducted in 48 healthy male volunteers  and will evaluate a new aqueous oral formulation of SMT C1100. The study will examine both the  safety and tolerability of the new formulation, and whether it can provide consistent levels of SMT  C1100 in the blood that non-clinical efficacy studies predict would be required to have a therapeutic benefit in DMD patients. The formulation has been developed so it will be appropriate for use by all patients.

Results from the trial are expected by the end of 2012 and a successful outcome from the Phase I  trial is expected to lead to evaluation of SMT C1100 in DMD patients. A drug like SMT C1100 that  could treat all DMD patients has the potential to generate annual sales in excess of $1 billion.  "We're extremely pleased that SMT C1100 will now move from testing in vivo to testing in healthy  humans" said Jane Larkindale, MDA's Director of Translational Research. "We have good  evidence from laboratory studies that this drug's mechanism of action is valid for slowing the progression of this degenerative muscle disease, and we hope that this new trial will show that it can be effectively and safely delivered to humans."

Glyn Edwards, Chief Executive Officer of Summit added: "Our plans to commence a new Phase I  trial for SMT C1100 continue to progress well with the necessary regulatory approval now in place.  This study represents an important development milestone for this programme with a positive outcome having the potential to add considerable value to this asset, and bring an urgently needed  treatment for this fatal disease a step closer."

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