Oxford, UK, 22 October 2012 – Summit (AIM: SUMM), a UK drug discovery company, is pleased to announce that it has extended its partnership with the Wellcome Trust through a translational research award worth up to £4.0 million ($6.5 million) to support the development of SMT 19969 to clinical proof of concept studies. SMT 19969 is a novel, oral small molecule being developed as a specific antibiotic for the treatment of infections caused by C. difficile.
“Summit is delighted to extend its partnership with the Wellcome Trust to support the development of one of our core programmes,” commented Glyn Edwards, Chief Executive Officer of Summit. “This Wellcome Trust award endorses the potential of SMT 19969, our promising antibiotic for the treatment of serious infections caused by C. difficile bacteria, and will provide non-dilutive funding to de-risk its development as it advances through important clinical milestones.”
“C. difficile infection represent a serious healthcare threat and this £4.0 million translational award underlines the Wellcome Trust’s commitment to supporting the development of new and effective antibiotic treatments,” commented Ted Bianco, Director of Technology Transfer at the Wellcome Trust. “We are pleased to be extending our successful partnership with Summit and look forward to testing in the clinic the potential of the SMT 19969 drug.”
Under the terms of the award, Summit will be eligible for up to £4.0 million in staged, success-based payments. Summit will immediately receive £1.26 million that will support a Phase 1 clinical trial in healthy volunteers and additional non-clinical studies designed to enhance the clinical data package. The Phase 1 trial is expected to commence by the end of 2012 with results expected in H1 2013. A successful outcome would trigger a further three payments from the Wellcome Trust with these contributing significantly towards undertaking a Phase 2 proof of concept trial in patients.
The award is being made as part of the Wellcome Trust’s Translation Award programme. This represents the second funding award the Wellcome Trust has made to support Summit’s C. difficile antibiotic programme and follows an award made under the Seeding Drug Discovery Initiative in 2009. A new funding agreement has been signed under which the Wellcome Trust share in net revenues generated by commercialisation of the programme.
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 of resistance development coupled with an excellent safety profile.
Translational Award Terms
The translational award will be drawn-down in staged-payments as follows:
Payment Released on
£1.26 million Start of translational award
£0.74 million Completion of Phase 1 clinical trial
£1.9 million Submission of Phase 2 IND/CTA
£0.1 million Completion of Translational Award
The total cost of completing the Phase 1 and Phase 2 trials is estimated at £6.5 million. The Wellcome Trust Translational Award will contribute £4.0 million towards this with the remainder to be contributed by Summit. At the end of the translational award, the Wellcome Trust is eligible to receive a share of net revenues Summit generates related to the C. difficile programme upon its commercialisation.
Conditions exist within the funding agreement for the full or partial repayment of the award that are commercially reasonable to Summit. These include a sale of the business, fraudulent behaviour or wilfully withholding material information 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 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
Singer Capital Markets
(Nominated Adviser and Joint broker)
Shaun Dobson / Jenny Wyllie
Tel: +44 (0)203 205 7500
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
(U.S. media contact)
Michelle Avery
Tel: +1 781-235-3060
Forward Looking Statements
This document contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as “anticipates”, “intends”, “plans”, “seeks”, “believes”, “estimates”, “expects” and similar references to future periods, or by the inclusion of forecasts or projections. Forward-looking statements are based on the Company’s current expectations and assumptions regarding our business, the economy and other future conditions. Because forward-looking statements relate to the future, by their nature, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. The Company’s actual results may differ materially from those contemplated by the forward-looking statements. The Company cautions you therefore that you should not rely on any of these forward- looking statements as statements of historical fact or as guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements and regional, national, global political, economic, business, competitive, market and regulatory conditions.
