14 June 2017
SUMMIT THERAPEUTICS REPORTS FINANCIAL RESULTS FOR THE FIRST QUARTER ENDED 30 APRIL 2017 AND OPERATIONAL PROGRESS
Oxford, UK, 14 June 2017 – Summit Therapeutics plc (AIM: SUMM, NASDAQ: SMMT), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy (‘DMD’) and C. difficile infection (‘CDI’), today reports its unaudited financial results for the first quarter ended 30 April 2017.
“Over the past quarter and in recent months, we have made meaningful advances in both our DMD and CDI programmes to bring these programmes closer to the patients in need. We continue to progress our PhaseOut DMD clinical trial of our lead utrophin modulator, ezutromid, in the treatment of DMD. We achieved a major milestone in the programme with the completion of enrolment into PhaseOut DMD, triggering a $22 million payment from Sarepta. In addition, we have made provisions for patients in the trial to remain on ezutromid beyond the initial 48-weeks of the trial, which will allow us to monitor safety and efficacy data related to longer-term dosing. We look forward to reporting 24-week biopsy, MRI and functional data in the first quarter of 2018 for what could be the first disease modifying treatment for all patients with DMD. “As we continue to prepare our other lead product candidate, ridinilazole, for Phase 3 clinical development, a recent Lancet Infectious Diseases publication highlighted the novel antibiotic’s differentiation and promise as a potential treatment for CDI, as evidenced by the Phase 2 CoDIFy clinical data. We believe the robust design of the Phase 3 clinical programme, which has received input from the US Food and Drug Administration and European Medicines Agency, has the potential to underpin ridinilazole as a potential front-line treatment for CDI.”
Mr Glyn EdwardsChief Executive Officer of Summit
Utrophin Modulation Programme for DMD
- Completed enrolment into PhaseOut DMD in May 2017. PhaseOut DMD is a 48-week, open label Phase 2 clinical trial that has enrolled 40 patients at sites in the UK and US. The trial aims to establish proof of concept of ezutromid and is evaluating a range of muscle structure, muscle health and functional endpoints.
- Expecting to report full 24-week data analysis from PhaseOut DMD in Q1 2018. This data set will include 24-week biopsy data from all patients who provide a 24-week biopsy sample (approximately 20). In addition, Summit expects to report 24-week MRI and functional data from all 40 patients in the trial. Top-line data from the complete 48-week clinical trial are expected in Q3 2018.
- Received support from an Independent Data Monitoring Committee for the extension of PhaseOut DMD following its interim review of safety and tolerability data. The extension phase will allow Summit to continue to gather long-term safety and efficacy data and is expected to last until ezutromid either receives marketing approval in relevant countries or its development is discontinued. In May 2017, Summit received the necessary regulatory approvals for the extension phase.
- Outlined Phase 3 development programme for the novel antibiotic ridinilazole following input from the US Food and Drug Administration and European Medicines Agency. The primary endpoint of the Phase 3 trials is expected to test for superiority in sustained clinical response compared to vancomycin as the Company seeks to further differentiate ridinilazole from currently marketed CDI treatments and those in late-stage development. Preparation for the Phase 3 clinical trials is ongoing with the trials planned to start H1 2018.
- Continuing to explore various funding options for the Phase 3 development programme as the Company seeks to maximize the value of ridinilazole. Options include potentially entering into a collaboration with a third party or securing meaningful non-dilutive funding from government entities and philanthropic, non-government and not for profit organisations.
- Published Phase 2 CoDIFy clinical trial results in The Lancet Infectious Diseases. CoDIFy evaluated ridinilazole against the standard of care antibiotic, vancomycin, for the treatment of CDI. The results showed ridinilazole demonstrated substantial clinical benefit over vancomycin. This included ridinilazole achieving statistical superiority over vancomycin in sustained clinical response, a composite endpoint of cure at the end of treatment and no recurrence 30 days after treatment, a result which was driven by a large numerical reduction in recurrent disease.
- Planning to report data from an exploratory Phase 2 clinical trial evaluating ridinilazole against the antibiotic fidaxomicin later this year. A key objective of the trial is to determine the relative impact on the patients’ microbiomes of treatment with ridinilazole compared to fidaxomicin.
- Strengthened R&D team with Chief Operating Officer Dr David Roblin expanding his role to include serving as Chief Medical Officer and appointments of Dr Anne Heatherington as Head of Clinical Development and Quantitative Sciences and Dr Dave Powell as Head of Research. These appointments, announced in May 2017, will help ensure the Company has the leadership, depth of knowledge and expertise needed to support its clinical and preclinical pipeline.
- Cash and cash equivalents at 30 April 2017 of £19.4 million compared to £28.1 million at 31 January 2017.
- $22 million milestone payment to Summit triggered in May 2017, post the period under review, under the terms of the licence and collaboration agreement with Sarepta Therapeutics Inc. (‘Sarepta’).
- Loss for the three months ended 30 April 2017 of £4.8 million compared to a loss of £5.4 million for the three months ended 30 April 2016.
About Summit Therapeutics
Summit is a biopharmaceutical company focused on the discovery, development and commercialisation of novel medicines for indications for which there are no existing or only inadequate therapies. Summit is conducting clinical programmes focused on the genetic disease Duchenne muscular dystrophy and the infectious disease C. difficile infection. Further information is available at www.summitplc.com and Summit can be followed on Twitter (@summitplc).
For more information, please contact:
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+1 617 225 4455
Cairn Financial Advisers LLP
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Aubrey Powell / Lauren Kettle
Tel: +44 (0)20 7496 3000
MacDougall Biomedical Communications
(US media contact)
Consilium Strategic Communications
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Forward Looking Statements
Any statements in this press release about our future expectations, plans and prospects, including statements about development and potential commercialisation of our product candidates, the therapeutic potential of our product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential benefits and future operation of the collaboration with Sarepta Therapeutics Inc., including any potential future payments thereunder, any other potential third-party collaborations and expectations regarding the sufficiency of our cash balance to fund operating expenses and capital expenditures, and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, expectations for regulatory approvals, availability of funding sufficient for our foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the "Risk Factors" section of filings that we make with the Securities and Exchange Commission, including our Annual Report on Form 20-F for the fiscal year ended 31 January 2017. In addition, any forward-looking statements included in this press release represent our views only as of the date of this release and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update any forward-looking statements included in this press release.
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