Date: 2014-07-03
Type of information: Treatment of the first patient
phase: 2
Announcement: treatment of the first patient
Company: Summit (UK)
Product: SMT19969
Action
mechanism: SMT19969 is a novel, oral small molecule antibiotic that is being developed specifically for the treatment of CDI. Results from non-clinical efficacy studies show that SMT19969 combines potent bactericidal activity against C. difficile with exceptionally high levels of antibacterial selectivity. This targeted antibiotic has displayed efficacy in two key disease models while showing complete protection from recurrent disease. A Phase 1 trial conducted in healthy volunteers showed SMT19969 to be safe and well tolerated at all doses tested. In addition, a significant reduction in total clostridia but not in other bacterial groups was reported which demonstrated that SMT19969 was highly sparing of gut flora.
Disease: Clostridium difficile infection
Therapeutic area: Infectious diseases
Country: USA, Canada
Trial
details: The Phase 2 trial, named CoDIFy, is a randomised, double-blind, active comparator study that will evaluate the efficacy of SMT19969 relative to vancomycin, the current standard of care in the treatment of CDI following ten days of dosing. The primary endpoint of the trial will measure the sustained clinical response, which is defined as cure from the initial infection with no recurrence within 30 days post end of treatment. The safety and tolerability of SMT19969 will also be evaluated. The study will recruit approximately 100 patients randomised into two equally sized treatment arms receiving SMT19969 and vancomycin respectively.The study is being performed in North America and will involve approximately 25 trial sites in the US. Summit has now received clearance from Health Canada regarding its Clinical Trial Application which adds up to five additional study sites in Canada. Top line data from this trial is expected to be reported in the first half of 2015.
Latest
news: * On July 3, 2014, Summit, a drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy and C. difficile infection ('CDI'), announces that the first patients have been dosed in its Phase 2 proof of concept clinical trial that is evaluating SMT19969 for the treatment of CDI. * On March 18, 2014 , Summit announce clearance by the FDA of its Investigational New Drug application (IND) to initiate a Phase 2 proof of concept study of the novel antibiotic SMT19969 for the treatment of CDI. The submission of this application has resulted in a £1.9m milestone payment to Summit by the Wellcome Trust, proceeds of which will support the study. This payment is part of a £4.0m Translational Award from the Wellcome Trust for the development of SMT19969.
