We are disappointed to learn that Summit Therapeutics plc today announced that their PhaseOut DMD trial has not met its primary or secondary endpoints after 48 weeks of treatment of ezutromid in patients with Duchenne. Based on this outcome, Summit is discontinuing its development of ezutromid and as a result, will be implementing cost reduction measures. We will learn more about this data and these results when Summit presents later this week at the 2018 PPMD Conference.

 

 

Summit’s Letter to the Community:

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 michelle.avery@summitplc.com.

Sincerely,

Glyn Edwards, CEO of Summit

Summit’s FAQs:

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.

Summit’s Press Release:

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.