MND Association update: MIROCALS trial

Firstly, we would like to acknowledge the deep frustration there is in the MND community around the ongoing wait for the publication of the results of the MIROCALS trial. We share that frustration.

Like you, we expected the full results of the trial to be published soon after the topline results were announced in December 2022. It is bitterly disappointing that it is taking so long for the detailed results, for what may be an effective treatment for MND, to be published.  You – and those of us working with and supporting you – need answers.

As we have shared previously, from our limited role in the Consortium, we neither have access to the full trial results nor have been in a position where we could effectively influence bringing forward their publication or establishing a timeline for this to be done.

We deeply regret the undue stress and anxiety this lack of information, knowledge and clarity is causing you.

As an Executive team and Board, we have been actively listening to the challenges from people in our community, reflecting long and hard on the situation we all find ourselves in, and considering carefully what we can do. Our priority as a membership organisation will always be listening to and acting in the best interests of people affected by MND. We know that, in this instance, some people feel we haven’t done that.  

Our Board of Trustees took the decision to hold an extraordinary Board meeting on Friday 10 May to decide how we move forward. The discussions at the meeting were challenging, constructive and very heartfelt. Most of our Trustees have a personal connection with MND, with all of us round the table bringing our own unique perspective, professional expertise, and knowledge.

Our role in the Consortium, which was set up back in 2015, is limited to supporting the delivery of the trial in the UK and disseminating the results when they are available. We don’t own any intellectual property related to the trial, which includes the trial results.  

We haven’t been party to or involved in the development of any commercial agreements with ILTOO Pharma, the pharmaceutical company engaged by the Consortium, and we don’t have a role where we can influence what it does or how it works.

As we have always said, there is no financial interest for us in this – we haven’t received any money from the Consortium or from ILTOO Pharma, nor are we entitled to any.  

After careful consideration, the Board decided that to leave the Consortium would only reduce the already limited level of influence we have and therefore be counterproductive. Having said this, the Board’s view is that we should continue to regularly review the decision to remain as a member of the Consortium.

The Board also decided we should use our Consortium membership to take a more formal approach than we have done so far.

With the support of our lawyers, we have this week written to Consortium members in the strongest terms. We have specifically asked for a full explanation about why it is taking so long to publish the results, a clear timetable for publication and the steps being taken to ensure there are no further delays. We have also asked questions about any commitments ILTOO Pharma is required to abide by in the commercial agreement to ensure people with MND in the UK have access to any treatment which proves to be effective at the earliest possible opportunity.

Going forward, there are clearly lessons to be learnt from this experience. Given the lack of influence we have so far been able to have on the publication of the results and the impact this has had on our community, the Board has committed to reviewing our original decision to become involved in the Consortium. The charity operates very differently from when we joined the Consortium nine years ago. We have strengthened our decision-making processes around research investment, we have strengthened our governance and we have new members of our Board and Executive Leadership Team including the Chair and Chief Executive roles. But there are always lessons to be learnt and it is vital we take those lessons forward, particularly when considering the role we, as a charity, should and can play in the future.  

But, for now, our sole focus around MIROCALS is getting the results published as quickly as possible. Whether or not this proves to be an effective treatment, people with MND and those of us in the MND community have a right to know.

We will let you know, no later than the end of June, when we have an update.  

Tanya Curry

Chief Executive, Motor Neurone Disease Association