27 March 2024 News

We are disappointed that the European TUDCA-ALS phase 3 clinical trial of tauroursodeoxycholic acid (TUDCA) did not meet its primary aim, a reduction in the progression of motor neurone disease (MND) measured by the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R).

The TUDCA-ALS consortium has published the top-line results of the phase 3 clinical trial, which also shows there were no significant differences observed across secondary aims.  The trial ran over 18 months, with 25 European sites participating in the study across seven European countries.

These results follow the publication in early March of the PHOENIX trial by Amylyx Pharmaceuticals. This Phase 3 clinical trial tested AMX0035, a combination of sodium phenylbutyrate and TUDCA. The PHOENIX trial also did not meet its primary aim of reaching statistically significant improvement in people living with MND, also measured by the ALSFRS-R functional rating scale.

This is not the news we hoped for, and we understand that these trial results are extremely disappointing for people with MND as they show no substantial clinical benefit of TUDCA.

Anyone currently taking TUDCA should contact their MND nurse or neurologist if they require clinical advice following the release of these findings. 

The charities will continue to update the MND community with any further news and the full results once they are available.