The recent announcement of the positive results from the phase 2 CENTAUR trial are exciting and promising for the TUDCA-ALS trial.
The recent publication of the results from the CENTAUR Trial is of great interest to the TUDCA-ALS consortium. The CENTAUR trial was a phase 2/3 clinical trial looking at a drug named AMX0035, which is a combination of phenylbutyrate and tauroursodeoxycholic acid (TUDCA).
The CENTAUR trial followed 137 participants (89 taking AMX0035 and 48 taking a placebo) in the United States, for a period of 24 weeks. The results suggest that the treatment with AMX0035 has a clinically meaningful benefit and a favourable safety profile for people living with ALS.
The results of the CENTAUR trial are in line with those of a pilot phase 2 study, looking at the safety and efficacy of TUDCA on 60 people with ALS. This study suggests that TUDCA plays a role in delaying the progression of the disease, thus showing great promise for its use as an add-on treatment for ALS’ .
The currently ongoing TUDCA-ALS study is a phase 3 clinical trial supported by the European Commission, which aims to ascertain the long-term effectiveness and safety of TUDCA in people living with ALS. TUDCA-ALS will follow 440 participants in seven countries in Europe. Participants will be taking 1g of TUDCA or matched placebo twice a day, for a total 78 weeks (18 months).
The TUDCA-ALS consortium comments that the recent results from the CENTAUR trial confirm the great potential of TUDCA as an add-on treatment in people living with ALS. Given this recently evolved background, the TUDCA-ALS trial is now even more in the position to provide fundamental answers to ALS patients in Europe and worldwide.
If you would like to learn more about the study and how to take part, please visit https://www.tudca.eu/take-part/.