Date: 2013-06-17
Type of information: Initiation of preclinical development
phase: 1
Announcement: completion of the trial
Company: Summit (UK)
Product: SMT19969
Action
mechanism: antibiotic. SMT 19969 is a novel, oral small molecule antibiotic that is being specifically developed for the treatment of C. difficile infections. Results from non-clinical efficacy studies show that SMT 19969 combines potent activity against C. difficile with high levels of antibacterial selectivity. This narrow spectrum antibiotic has displayed efficacy in two key disease models while showing complete protection against recurrent disease. SMT 19969 is targeted to the GI tract; the site of infection, and has exceptionally low levels of resistance development coupled with an excellent safety profile.
Disease: infections caused by Clostridium difficile
Therapeutic area: Infectious diseases
Country: UK
Trial
details: The Phase 1 clinical trial was a double-blind, placebo controlled study conducted in a total of 56 healthy male volunteers. After a single dosing phase, the volunteers received twice-daily doses of SMT 19969 for 10 days. In addition, the study measured the impact of the drug on the natural gut flora.
Latest
news: * On October 31, 2012, Summit has announced that it has initiated dosing of healthy volunteers in the Phase 1 clinical trial of SMT 19969, the novel, oral small molecule being developed as a selective antibiotic for the treatment of infections caused by the bacteria C. difficile. The trial is being supported as part of a £4.0m Translation Award from the Wellcome Trust. Headline results from the Phase 1 trial are expected to be reported in H1 2013.* On June 17, 2013, Summit, a drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy and C. difficile infections (‘CDI’), has announced that it has achieved a clinical research milestone in the development of its novel CDI antibiotic SMT 19969 triggering a £740,000 payment under the Company’s existing Translation Award from the Wellcome Trust. The milestone was achieved after SMT 19969 successfully completed a Phase 1 clinical trial in healthy volunteers. The funding will support the on-going clinical development of the programme. Current development activities are focussed on preparing SMT 19969 to enter Phase 2 clinical proof of concept trials in patients with CDI. This work includes the manufacture of the final dose form of SMT 19969 and finalising the design of the patient trial with the regulators and company clinical advisors. It is anticipated that a Phase 2 clinical trial will commence in H1 2014.
* On April 24, 2013, Summit, a UK drug discovery and development company, has announced that its narrow-spectrum antibiotic SMT 19969 for the treatment of C. difficile infection has successfully completed a Phase 1 clinical trial. The study showed that SMT 19969 was safe and well tolerated at therapeutically relevant doses.
In addition, the study measured the impact of the drug on the natural gut flora. The results show that SMT 19969 is highly sparing of gut flora with only the clostridia bacterial family being reduced to levels below the limit of detection.
The Wellcome Trust has supported the programme from its preclinical development and Summit received an additional Translational Award from the Wellcome Trust to continue progression through Phase 2 clinical trials.
* On September 25, 2012, Summit has received approval from the UK regulatory body, the Medicines and Healthcare products Regulatory Agency (MHRA), to commence a Phase I clinical trial for SMT 19969 for the treatment of C. difficile infections. Preclinical data on SMT 19969 will be presented at the international conference, \'One Bug, One Drug\', being held in Cambridge, UK. The preclinical data being presented at One Bug, One Drug will highlight that SMT 19969 has the potential to overcome the limitations associated with existing CDI antibiotics. In non-clinical efficacy studies, SMT 19969 combines potent activity against C. difficile with exceptionally high levels of antibacterial selectivity. Importantly, SMT 19969 demonstrates efficacy in two key disease models and complete protection against recurrent disease. With these promising data, SMT 19969 is on-track to advance into a Phase I trial by the end of 2012 with results expected to be reported in H1 2013.
