Summit Announces PhaseOut DMD Did Not Meet Primary Endpoint
Summit Therapeutics plc today announces PhaseOut DMD has not met its primary or secondary endpoints after 48 weeks of treatment of ezutromid in patients with Duchenne muscular dystrophy.
Please find below a letter from CEO, Glyn Edwards:
To the DMD community,
After reviewing the top-line results of PhaseOut DMD, we have made the difficult decision to discontinue the development of ezutromid.
We recognize that this decision will be disappointing for the Duchenne community, but the data from PhaseOut DMD were clear that ezutromid, while well-tolerated, did not provide a benefit to patients with DMD.
These results are not what we had hoped for, and certainly not what we had expected based on the encouraging interim results from PhaseOut DMD. But, they provide a clear answer to the important scientific question of ezutromid’s effect in DMD. The results provided no evidence that ezutromid is having a meaningful effect on slowing DMD progression. We therefore cannot support further development of ezutromid. We are now working with our clinical trial investigators to bring the PhaseOut DMD clinical trial and associated extension phase to a close. Patients in PhaseOut DMD should contact their study doctors for more information.
We sincerely thank the patients, families and clinical trial sites who have been involved in all of our clinical trials of ezutromid. We plan to explore ways that the information gathered as part of PhaseOut DMD can be made available to support other research activities in DMD for the benefit of the entire community.
We are also grateful for the support that we’ve had from patient organizations worldwide in the development of ezutromid.
We believe that the future of Duchenne research is bright. There are numerous clinical trials and research studies taking place in this field, and there is hope on the horizon for all those living with DMD.
If you have further questions, please contact Michelle Avery, PhD, our Director of Patient Engagement, at [email protected]
Glyn Edwards, CEO of Summit
1. What do these data mean?
We designed PhaseOut DMD to answer if ezutromid is safe and efficacious in patients with DMD. Unfortunately, the results are quite clear that ezutromid is not having a clinical benefit for patients with DMD. It does continue to be well-tolerated, but given the lack of evidence we’ve seen, we have decided to discontinue its development.
2. Will patients in PhaseOut DMD be allowed to continue to receive ezutromid?
We are working with our clinical trial investigators to bring the trial and extension phase to a close, including any patients who have been enrolled into the additional cohort of the trial that was opened in March 2018. We have taken this difficult decision as the data were clear that patients in PhaseOut DMD were not benefitting from ezutromid treatment.
3. Are you continuing to work on future generation compounds?
While we still believe utrophin modulation could have a place in the treatment of DMD and other dystrophinopathies, our focus will be on the development of our new mechanism antibiotic pipeline.
Press release from Summit is below or read on their website
Summit Announces PhaseOut DMD Did Not Meet Primary Endpoint
Ezutromid Development to be Discontinued
Summit to Focus on Advancing its Pipeline of New Mechanism Antibiotics
Conference Call Scheduled for 8:00am EDT / 1:00pm BST
Oxford, UK, and Cambridge, MA, US, 27 June 2018 - Summit Therapeutics plc (AIM:SUMM, NASDAQ:SMMT) today announces PhaseOut DMD has not met its primary or secondary endpoints after 48 weeks of treatment of ezutromid in patients with Duchenne muscular dystrophy ('DMD'). PhaseOut DMD was a multi-centre, open-label Phase 2 clinical trial of the utrophin modulator, ezutromid.
Based on this outcome, the Company is discontinuing its development of ezutromid and as a result, will be implementing cost reduction measures. Summit will now focus its operations on the development of its pipeline of new mechanism antibiotics. The Company's lead product candidate, ridinilazole, is expected to enter Phase 3 clinical trials for the treatment of C. difficile infection in Q1 2019.
"These data come as a great disappointment to us and to all those living with DMD," said Glyn Edwards, Chief Executive Officer of Summit. "While we believe utrophin modulation could still have a place in the treatment of DMD, it is clear that ezutromid is not providing a benefit for patients. We therefore feel that our resources are better focussed on the development of our promising pipeline of new mechanism antibiotics.
"We sincerely thank the patients, families and clinical trial sites involved in all of the ezutromid clinical trials for their commitment to advancing research in DMD. We hope that the information we have gathered can ultimately be used to benefit ongoing research in DMD."
Summit is currently working with the clinical trial investigators in PhaseOut DMD to bring the trial and associated extension phase to a conclusion. The Company plans to also explore ways that information gathered as part of PhaseOut DMD can be made available to support other research activities in DMD for the benefit of the DMD community.
About PhaseOut DMD
A total of 40 boys with DMD were enrolled in PhaseOut DMD, with 38 completing the 48-week clinical trial. Ezutromid was dosed twice a day at either 1000 mg (F6 formulation) or 2500 mg (F3 formulation). The primary endpoint was the change from baseline in magnetic resonance parameters related to the leg muscles. Biopsy measures evaluating utrophin and muscle damage were included as secondary endpoints, with patients having two biopsies: one at baseline and their second after either 24 weeks or 48 weeks of ezutromid treatment. Exploratory endpoints included the six-minute walk distance, the North Star Ambulatory Assessment and patient reported outcomes. While statistical decreases in developmental myosin and magnetic resonance T2 measures were seen after 24 weeks of treatment, these effects were not seen after 48 weeks of treatment. Ezutromid was generally well-tolerated in the trial.
Conference Call Details
Summit will host a conference call and webcast to review the data today at 8:00am EDT / 1:00pm BST. To participate in the conference call, please dial +1 929-477-0402 (US local number) or +44 (0)330 336 9126 (UK and international participants) and use the conference confirmation code 7830699. 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 completion of the call.
About Summit Therapeutics
Summit is a biopharmaceutical company focused on the discovery, development and commercialisation of novel medicines for which there are no existing or only inadequate therapies. Summit's clinical programmes focus on the infectious disease C. difficile infection and the neuromuscular disease Duchenne muscular dystrophy. Further information is available at www.summitplc.com and Summit can be followed on Twitter (@summitplc).
For more information, please contact:
|Glyn Edwards / Richard Pye (UK office)||Tel:||44 (0)1235 443 951|
|Erik Ostrowski / Michelle Avery (US office)||+1 617 225 4455|
|Cairn Financial Advisers LLP (Nominated Adviser)||Tel:||+44 (0)20 7213 0880|
|Liam Murray / Tony Rawlinson|
|N+1 Singer (Joint Broker)||Tel:||+44 (0)20 7496 3000|
|Aubrey Powell / Jen Boorer|
|Panmure Gordon (Joint Broker)||Tel:||+44 (0)20 7886 2500|
|Freddy Crossley / James Stearns|
|MSL Group (US)||Tel:||+1 617 684 6557|
|Jon Siegal||[email protected]|
|Consilium Strategic Communications (UK)||Tel:||+44 (0)20 3709 5700|
|Mary-Jane Elliott / Jessica Hodgson /||[email protected]|
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 implementation of cost reduction measures, the timing of initiation, completion and availability of data from clinical trials, 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 2018. 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).
Published on 27 June 2018Share this article Categories DMD research