4 April 2024 Research

The MND Association, MND Scotland and My Name’5 Doddie Foundation understand the continued frustration within the MND community that we are still awaiting publication of data from the MIROCALS trial. We share that frustration.

In February, as the three main MND charities, we shared an update that stated we had written a joint letter to regulators alerting them to the imminent publication of the data. We have now received a response from the Medicines and Healthcare products Regulatory Agency (MHRA) indicating they do not have capacity to accommodate our request for a meeting over the coming months.

We also wrote to ILTOO Pharma, the French company selected by the MIROCALS consortium as the organisation to commercialise low dose IL2, should the results be sufficiently conclusive. The charities have not yet received a response to this letter.  

This is, of course, disappointing and we are continuing to proactively pursue engagement with both the MHRA and ILTOO to ensure we are well placed once the trial results are published.  

While we await the publication of the results, the charities have also worked with people with MND and neurologists to jointly create a package of information to help make low dose IL-2 available via an off-label route, again, if the trial results are positive.

We are also working with the UK MND Clinical Studies Group (which includes leading neurologists, researchers and people with MND) which will provide an agreed clinical consensus on the data, as soon as it is available. We hope this will provide a strong and united basis on which to apply leverage – if the MIROCALS trial shows a positive outcome - so that people with MND can access treatment as quickly as possible.

We would like to reiterate that the charities are committed to pursuing every avenue available to us to make proven treatments available to people with MND as quickly as possible.