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Summit Corporation Receives Regulatory Approval to Commence Phase I Clinical Trial of Selective Antibiotic for the Treatment of C. Difficile Infections


9/25/2012 10:34:42 AM

Oxford, UK, 25 September 2012 – Summit (AIM: SUMM), a UK drug discovery company, is pleased to announce that it 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, an oral small molecule antibiotic that is selective for the treatment of C. difficile infections (‘CDI’). Preclinical data on SMT 19969 will be presented later today at the international conference, ‘One Bug, One Drug’, being held in Cambridge, UK.

“Summit is pleased to receive regulatory approval to commence clinical trials of SMT 19969 as we are excited about its potential as a treatment for C. difficile infections,” commented Glyn Edwards, Chief Executive Officer of Summit. “SMT 19969 is a narrow-spectrum antibiotic being specifically developed to treat this serious illness and the compelling package of preclinical data being presented today highlights that it has an ideal profile to protect against recurrent disease; the key clinical issue associated with this illness.”

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. In addition, SMT 19969 is targeted to the gastrointestinal (‘GI’) tract, the site of infection, and has exceptionally low levels of resistance development while maintaining an excellent safety profile.

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. The Phase I trial will be a dose-escalating, double-blind, placebo-controlled study conducted in healthy volunteers and will assess safety, tolerability and pharmacokinetics of SMT 19969 when administered orally.

Copies of the presentation will be available on request from investors@summitplc.com.

About C. difficile Infection

C. difficile infection (‘CDI’) is a serious healthcare threat in hospitals, long-term care homes and the wider community. It is a serious illness that is caused by infection of the colon by the bacteria C. difficile which produces toxins that cause inflammation, severe diarrhoea and in the most serious cases can be fatal. Patients typically develop CDI following the use of broad-spectrum antibiotics that disrupt the normal gastrointestinal (gut) flora and so allow the C. difficile bacteria to flourish. Existing CDI antibiotics cause further damage to the gut flora and are associated with recurrent disease. This is the key clinical issue as repeat episodes are typically more severe and associated with an increase in mortality rates and healthcare costs.

About SMT 19969

SMT 19969 is a novel, oral small molecule antibiotic that is being specifically developed for the treatment of CDI. Results from non-clinical efficacy studies show that SMT 19969 combines potent activity against C. difficile with exceptionally 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 ofresistance development coupled with an excellent safety profile.

About Summit

Summit is an Oxford, UK based drug discovery Company targeting high-value areas of unmet medical need including Duchenne Muscular Dystrophy and C. difficile infection. Summit is listed on the AIM market of the London Stock Exchange and trades under the ticker symbol SUMM. Further information is available at www.summitplc.com.


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