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Summit Corporation to submit trial application for Duchenne Muscular Dystrophy drug - UPDATE

Last updated: 11:22 14 Feb 2012 GMT, First published: 12:22 14 Feb 2012 GMT

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Drug discovery firm Summit Corporation (LON:SUMM) said the manufacture and formulation of its “first in class” drug SMT C1100 remains on schedule.

The company expects to submit a clinical trial application (CTA) to the Medicines and Healthcare products Regulatory Agency (MHRA) during the current quarter.

The CTA approval would enable the company to start the Phase I trial and report headline results from this study in the third quarter of 2012.

The company said SMT C1100 is a potential first-in-class disease modifying drug for the treatment of the fatal rare disease Duchenne Muscular Dystrophy (DMD). Non-clinical studies of SMT C1100 have found that the drug is able to restore and maintain the function of muscles.

The Phase I trial will evaluate the new formulation of SMT C1100, which will be appropriate for use by all DMD patients.  A successful outcome from the Phase I trial could lead to a Phase II study in DMD patients starting in the first half of 2013.

A drug to treat DMD has the potential to generate annual sales in excess of US$1 billion.

“This clinical trial represents a key development milestone for the programme with a successful outcome having the potential to add considerable value to this asset, and bring an urgently needed treatment for this terrible disease a step closer,” said executive chairman of Summit Corp Barry Price.

The trial is completely funded by the US$1.5 million agreement signed in December 2011 between Summit and several foundations.

Singer Capital analyst Shawn Manning says the DMD drug candidate is one of Summit’s potential partnering candidates, along with an Alzheimer’s treatment and a C. Difficile therapy.

“We expect that a co-development partner will be sought to progress the candidate into Phase-II trials, which could start as early as H1 2013. Clearly, SMT C1100 remains a valuable asset and we eagerly await news of further progress,” Manning said in a note to clients.

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