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Summit Corp. reports progress with DMD trial, but next phase delayed

Wed, 21st May 2014 12:43

Shares in Summit Corporation suffered a fall despite giving a generally positive report of the first phase of its Duchenne Muscular Dystrophy (DMD) trial which has examined the safety and tolerance of SMT C1100.The decline may be linked to a delay in the next patient study, which is expected to now start in the fourth quarter rather than the third.This is because a review of the preliminary trial data is expected to lead to a revision of future clinical trial plans in order to determine the optimal way, either through dietary means or drug formulation changes, to address the drug uptake differences between DMD patients and healthy volunteers, Summit explained. Notably, broker N+1 Singer did say the variability in blood plasma levels of SMT C1100 was a "slight disappointment", but concluded the overall trial had been "very encouraging". The results of the trial, which was conducted in 12 patients with DMD aged between five and 11 years old, showed that SMT C1100 was safe and well tolerated at all doses tested in the study, and that there were no issues with patient compliance. However, while all of the patients had variable blood plasma concentrations of SMT C1100, only two achieved concentrations similar to those of the adult volunteers in the 2012 phase 1 study. Initial evidence suggests that the variability in drug uptake may be due to differences in diet and to other disease-related factors.The non-placebo controlled trial also measured creatine kinase (CK) levels, an enzyme that is associated with muscle fibre damage and is elevated in boys with DMD. The study found that in the majority of patients there was a reduction in CK levels during dosing with SMT C1100, findings that were consistent with non-clinical in vivo efficacy studies in the mdx model of DMD that showed SMT C1100 reduced CK levels after only 15 days. "This first-ever trial of a utrophin modulator in DMD patients demonstrated the excellent safety profile of SMT C1100 with the study successfully achieving its primary endpoint," said Glyn Edwards, Chief Executive Officer of Summit. "In addition, the positive impact on the enzyme markers of muscle health was both unexpected and exciting with these data potentially representing SMT C1100's first signs of activity in DMD patients."The group's share price fell 6.88% to 7.45p by 13:06.NR

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