Summit Announces FDA Clearance of IND Application For Phase 2 Study of SMT19969
Oxford, UK, 18 March 2014 - Summit (AIM: SUMM), a drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy and C. difficile infection ('CDI'), announces clearance by the US Food and Drug Administration ('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.
"SMT19969 has demonstrated high selectivity for only clostridia in a Phase 1 study of healthy volunteers," commented Glyn Edwards, Chief Executive Officer of Summit. "If this profile is replicated in future studies, SMT19969 could potentially offer a differentiated and more beneficial option to current CDI treatments, which continue to undermine the natural balance of the gut flora and lead to recurrent disease. We are excited about initiating a Phase 2 proof of concept clinical trial with the continued support of the Wellcome Trust."
The Phase 2 study, named CoDIFy, will be a double blind, active controlled trial comparing the efficacy of SMT19969 to vancomycin (the current standard of care) in CDI patients through assessment of both initial cure rates and absence of recurrent CDI within 30 days of the end of treatment. The Phase 2 trial will recruit 100 patients with CDI and enrolment is expected to commence during H1 2014 at sites in the US and Canada.
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.
About C. difficile Infection
C. difficile infection ('CDI') is a serious healthcare threat in hospitals, long-term care homes and increasingly the wider community. It is a serious illness 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 C. difficile 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 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.
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.
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.
Source: Summit Corporation plc
Posted: March 2014