OXFORD, United Kingdom, Aug. 27, 2015 (GLOBE NEWSWIRE) -- Summit Therapeutics plc (NASDAQ:SMMT) (AIM:SUMM), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy (‘DMD’) and C. difficile infection (‘CDI’), today reports its financial results for the second quarter and half-year ended 31 July 2015.
Mr Glyn Edwards, Chief Executive Officer of Summit commented: “We have made very substantial progress with our utrophin modulator programme to treat boys with DMD with the recent announcement that our lead candidate, SMT C1100, achieved its primary objective in a Phase 1b clinical trial, allowing us to advance this molecule into a Phase 2 open-label trial that is expected to start by the end of this year. We further strengthened this programme with the publication of data on a second-generation utrophin modulator demonstrating its disease-modifying potential in animal models of this devastating disease. Importantly, we also received Fast Track designation from the US FDA for SMT19969 in CDI, highlighting the promise of our novel antibiotic treatment with the potential to address disease recurrence, the key clinical issue of CDI. With top-line data from our ongoing Phase 2 proof of concept trial in CDI expected to report in the fourth quarter of 2015, we continue to be excited about progress in both of our clinical programmes.”
RECENT OPERATIONAL HIGHLIGHTS
Utrophin Modulation Programme for DMD:
SMT C1100 Highlights
- Phase 1b modified diet clinical trial achieved primary objective in DMD
- Plasma absorption of SMT C1100 observed at a level suitable for further development
- SMT C1100 to progress into Phase 2 open-label clinical trial planned to commence in Q4 2015
- Key composition of matter patent granted by European Patent Office for SMT C1100
Utrophin Modulation Pipeline
- Positive preclinical data published on second-generation utrophin modulator showing increase in utrophin expression along entire length of muscle fibre, reduction in disease pathology and improvement in muscle function
CDI Programme:
SMT19969 Highlights
- Phase 2 proof of concept clinical trial of novel antibiotic SMT19969 against vancomycin on-going with top-line data expected to be reported in Q4 2015
- SMT19969 granted Fast Track status by the US Food and Drug Administration
- Grant of key patent in the US protecting the use of SMT19969 in the treatment of CDI
FINANCIAL HIGHLIGHTS
- Cash and cash equivalents at 31 July 2015 of £26.4 million compared to £11.3 million at 31 January 2015
- Loss for the three months ended 31 July 2015 of £4.0 million compared to a loss of £3.3 million for the three months ended 31 July 2014
- Initial Public Offering of American Depositary Shares in the US completed in March 2015 raising gross proceeds of $39.3 million
Conference Call
Summit will host a conference call and webcast to discuss the financial results for the second quarter and half-year ended 31 July 2015 today at 1:00pm BST / 8:00am EDT. To participate in the conference call please dial +44(0)20 7136 2050 (UK and international participants) or +1 718 354 1359 (US local number) and use the conference confirmation code 4691341. Investors may also access a live audio webcast of the call via the investors section of the Company’s website www.summitplc.com. A replay of the webcast will be available shortly after the presentation finishes.
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