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Summit Highlights Scientific Rigour of its PhaseOut DMD Clinical Trial at MDA Clinical ConferenceOXFORD, United Kingdom and CAMBRIDGE, Mass., March 14, 2018 (GLOBE NEWSWIRE) -- Summit Therapeutics plc (NASDAQ:SMMT) (AIM:SUMM) highlighted the rigour being utilised in the collection and analysis of muscle biopsies and magnetic resonance spectroscopy (‘MRS’) related data in its PhaseOut DMD clinical trial, at the 2018 MDA Clinical Conference in Arlington, VA. PhaseOut DMD is a Phase 2 open-label trial of the Company’s utrophin modulator, ezutromid, in patients with Duchenne muscular dystrophy (‘DMD’). Through this study, Summit is compiling a deep dataset for each patient in the trial, which includes the analysis of several thousand muscle fibres per biopsy sample. As part of this effort, steps are being taken to remove human bias through the automated reading of biopsy and MRS measurements at central sites. “Since DMD is a muscle-wasting disorder, it is critical for us to have high quality data from objective muscle health measurements as we assess ezutromid’s activity. As the collection of muscle biopsy and MRS measurements are a major intervention for patients in clinical trials, it means it is crucial this is done in a robust and reliable way,” said Dr David Roblin, Chief Medical Officer and President of R&D of Summit. “Our data collection and analysis methods used in PhaseOut DMD helped yield a high-quality dataset from all evaluable boys in the trial after 24-weeks of treatment. We are grateful to all the boys in the trial and excited about the interim findings that showed compelling signs of ezutromid activity.” The recently announced positive interim data from PhaseOut DMD showed that after 24 weeks of treatment, there was a significant and meaningful reduction in muscle damage, as well as a significant reduction in muscle inflammation, in patients treated with ezutromid. These data provide early evidence that ezutromid is modulating the production of utrophin protein and having its intended effect of stabilising muscle membranes, which has in turn led to early improvements in muscle health. Utrophin is a protein that can substitute for dystrophin, the protein that is missing in those with DMD the absence of which results in disease progression and premature death. Because Summit’s utrophin modulation approach is independent of the patient’s underlying dystrophin gene mutation, it could be applicable to all patients with DMD. Details of the Methodologies from the Poster Presentation Muscle inflammation is measured by T2- relaxation time using MRS. MRS of the soleus (calf) and vastus lateralis (thigh) muscles is performed at central imaging centres following a training and certification process. The MRS quantification is then performed by an automated blinded process. A copy of the poster is available in the Publications section of Summit’s website, www.summitplc.com. About PhaseOut DMD About Utrophin Modulation in DMD About Summit Therapeutics Contacts
Summit Forward-looking Statements Any statements in this press release about the Company’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company’s product candidates, the therapeutic potential of the Company’s product candidates, the potential commercialisation of the Company’s product candidates, the sufficiency of the Company’s cash resources, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals 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 or preclinical studies will be indicative of the results of later clinical trials, expectations for regulatory approvals, laws and regulations affecting government contracts, availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the "Risk Factors" section of filings that the Company makes with the Securities and Exchange Commission, including the Company’s Annual Report on Form 20-F for the fiscal year ended 31 January 2017. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release. This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014 (MAR). |