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Oxford, UK, 17 June 2013 - Summit (AIM: SUMM), a drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy and C. difficile infections (‘CDI’), announces 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.
“The successful outcome from our Phase 1 clinical trial demonstrated the potential of SMT 19969 to become an effective treatment for this life-threatening infectious disease,” commented Glyn Edwards, Chief Executive Officer of Summit. “SMT 19969 was shown to be safe and well tolerated in the trial while demonstrating encouraging evidence that this narrow spectrum antibiotic could target C. difficile bacteria without undermining the natural balance of gut flora, an important differentiation from current treatments. With the continuing support of the Wellcome Trust, we look forward to progressing into Phase 2 patient clinical trials.”
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.
SMT 19969 is novel small molecule antibiotic that is being developed to treat initial CDI and prevent recurrent disease. The development of SMT 19969 is being substantially supported by the Wellcome Trust through a Translation Award worth up to £4.0 million awarded in 2012, which will take the project through to completion of Phase 2 clinical trials.
About C. difficile Infection
C. difficile infection (‘CDI’) is a serious illness that is a major healthcare issue in hospitals, long-term care homes and increasingly in the wider community. It is an infection of the colon by the bacteria Clostridium difficile that results in 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 balance of the gut flora. Current CDI antibiotics cause further damage to the gut flora and are associated with recurrent disease in one third of patients, the key clinical issue. The global prevalence of CDI has risen in recent years and the number of hospital stays and deaths where the disease was the underlying cause has increased significantly. C. difficile is listed in the 2012 GAIN Act, a US government bill introduced to provide companies with greater commercial incentives to develop new antibiotics to counter the threat posed by specific pathogens.
About SMT 19969
SMT 19969 is a novel antibiotic being developed as a treatment for initial CDI and reduction in the incidence of recurrent disease. SMT 19969 combines excellent potency with unprecedented selectivity for C. difficile meaning it does not disrupt the balance of the healthy gut bacteria. This is expected to be important in significantly reducing recurrent CDI and improving treatment outcomes for patients. SMT 19969 successfully completed a Phase 1 clinical trial in healthy volunteers that showed it was safe, well tolerated and highly sparring of gut flora at therapeutically relevant doses. The development of SMT 19969 is being supported by a £4.0 million Translational Research award from the Wellcome Trust. About the Wellcome Trust
The Wellcome Trust is a global charitable foundation dedicated to achieving extraordinary improvements in human and animal health. It supports the brightest minds in biomedical research and the medical humanities. The Trust’s breadth of support includes public engagement, education and the application of research to improve health. It is independent of both political and commercial interests. www.wellcome.ac.uk
About Summit
Summit is an Oxford, UK based drug discovery and development 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 and follow Summit on Twitter (@summitplc).
For more information, please contact:
Summit
Glyn Edwards / Richard Pye Tel: +44 (0)1235 443 951
Nomura Code Securities
(Nominated Adviser and Joint broker)
Chris Collins / Jonathan Senior / Giles Balleny
Tel: +44 (0)20 7776 1200
Hybridan LLP
(Joint broker)
Claire Louise Noyce / Deepak Reddy
Tel: +44 (0)207 947 4350
Peckwater PR
(Financial public relations, UK)
Tarquin Edwards Tel: +44 (0)7879 458 364
tarquin.edwards@peckwaterpr.co.uk
MacDougall Biomedical Communications
(US media contact)
Michelle Avery Tel: +1 781-235-3060
Forward Looking Statements
This announcement contains “forward-looking statements”, including, but not limited to, statements about the discovery, development and commercialisation of programme assets. These forward-looking statements are statements based on the Company’s current intentions, beliefs and expectations, which include, among other things, the Company’s results of operations, financial condition, prospects, growth, strategies and the industry in which the Company operates. No forward-looking statement is a guarantee of future performance and actual results could differ materially from those expressed or implied in the forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements or information. Forward-looking statements and information by their nature involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements or information. These include but are not limited to: adverse results in clinical or preclinical development studies; delays in obtaining regulatory approval; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; being unable to secure partnership agreements to develop and commercialise programme assets; being unable to secure the necessary funding to conduct any proposed research and development studies; and the ability to retain and recruit key personnel. The Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statement contained in this announcement to reflect any changes in expectations with regard thereto or any changes in events, conditions or circumstances on which any such statement is based, except as required by applicable law.
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