Amylyx terminates open-label extension of the PHOENIX study

The pharmaceutical company Amylyx has announced that they will terminate the open-label extension of the PHOENIX study as of October 1st. This decision was made following the disappointing results of the PHOENIX study. 

On March 8, 2024, Amylyx announced that the first results of the PHOENIX study showed no effect of the drug AMX0035 (also known as RELYVRIO or ALBRIOZA) in people with ALS. Initially, it was decided to continue the open-label extension of the PHOENIX study in order to gather more long-term information about the drug.  

However, the decision has now been made to discontinue the open-label extension as of October 1st, 2024. Participants may also stop using the drug earlier, in consultation with their study physician. Amylyx still intends to collect information on survival. 

What is an open-label extension?

The open-label extension (OLE), is often the last period of trial. During this period, all participants of the study receive the active compound for an extended period of time to gather more information about the efficacy of the drug on the long-term.

Reaction TRICALS

Leonard van den Berg, chair of TRICALS, stated: “Continuing the open-label extension takes up time and energy for the participants of the PHOENIX study and the trial teams at the participating centres. Therefore, terminating the open-label extension is a logical consequence of the disappointing results of the PHOENIX study. We want to thank participants of the PHOENIX study for their dedication and time. We also want to express our support to all people with ALS. The negative outcomes of the PHOENIX study are and remain a major disappointment for the ALS community, and this decision reminds us of that once again.”