24 June 2024 Research

As many of you know, there has been huge interest in our community in the MIROCALS trial, which announced promising preliminary results at the end of 2022 but has not yet published its final results. Until we see those results, we can’t know whether or not the trial drug interleukin-2 has the potential to be an effective treatment for people with MND.  

In our update on MIROCALS last month, we promised to update you by the end of June. When we wrote those words, we hoped the final data might have been published by now. Unfortunately, this hasn’t happened. While we understand the data analysis needed to develop these final results has been complex, we’re deeply disappointed by the fact we still don’t have the final results a full year-and-a-half on from the preliminary results, and share the frustration we know the wait is causing.   

In their reply to a letter we sent last month, the researchers leading on MIROCALS assured us the paper with the final results is well advanced, but, frustratingly, they haven’t yet confirmed a publication date. There has been online speculation about potential dates, but we’re not sharing these as previously hoped-for publication dates have not materialised. We continue to urge the researchers to do everything they can to ensure the results are published as soon as possible.  

As we told you previously, we wrote to ILTOO Pharma, the pharmaceutical company engaged by the MIROCALS Consortium, asking a number of questions on behalf of the MND community. I am pleased to say ILTOO has replied and confirmed it sees the UK as an important market for ILT-101 (the name of the drug), if it is shown to be effective. 

The company also told us it has already started engaging with regulatory bodies. We’re also aware ILTOO is running a Managed Access Programme that could potentially be a route to accessing the drug, both before and after the data is published. We have asked ILTOO for clarification about how this is working in practice, and will share more when we hear. At the moment, we don’t have enough information to know if it’s a viable route for people to access the drug. We have heard some neurologists have contacted ILTOO about the programme, but haven’t received a response. 

We’ve also developed our own plans for working with the healthcare and regulatory systems to ensure we’re doing everything we can to help people with MND access ILT-101 as quickly as possible, if the data proves positive. If it does, we will be pushing for a response with the urgency the MND community expects. We are committed to playing our role in this, along with other interested people and organisations. In particular, we continue to work closely with the MND community, including our colleagues at My Name’5 Doddie Foundation and MND Scotland.  

We will also continue to update you with any news on a publication date. We are sure we speak on behalf of the whole MND community when we say we hope this will be soon.