First participants enrolled in PHOENIX trial
November 8, 2021
Amylyx Pharmaceuticals, Inc. today announced that the first participants have been dosed in their PHOENIX trial. This is a global study evaluating the safety and efficacy of the compound ‘AMX0035’ in people with ALS. The Phase 3 trial will be conducted at approximately 65 sites in Europe and the U.S. TRICALS is very excited to be collaborating with Amylyx on the European arm of their phase 3 trial.
PHOENIX is a follow-up clinical trial to the CENTAUR trial. This was a 24-week placebo-controlled study of 137 participants with ALS that evaluated the safety and efficacy of AMX0035. As published in the New England Journal of Medicine (NEJM), the study met its primary efficacy endpoint of slowing ALS progression as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R).
“Given the results from CENTAUR, it is especially important that we advance the scientific understanding of ALS and continue investigating AMX0035 for the hundreds of thousands of people living with the disease worldwide,” said Professor Leonard van den Berg, Chairman of TRICALS. “We’re looking forward to collaborating on the Phase 3 PHOENIX study with NEALS as it will take a global and unified effort to make promising advances for patients and their families.”
AMX0035 consists of a combination of two molecules: tauroursodeoxycholic acid (TUDCA) and sodium phenylbutyrate. Both were previously shown to be safe and well tolerated. The combination of the two drugs is believed to decrease nerve cell damage in people living with ALS. The PHOENIX trial will enroll approximately 600 participants with ALS within 24 months from symptom onset. The duration of the trial is 48 weeks. The primary efficacy outcome of the trial will be a joint assessment of ALSFRS-R total score progression and survival.
