This week, Amylyx Pharmaceuticals has made the decision to discontinue their Orion trial of AMX0035 for Progressive Supranuclear Palsy (PSP).
Amylyx began recruiting to this 2b trial in the EU and US early last year. It was hoped AMX0035, which is an oral, fixed-dose combination of sodium phenylbutyrate (PB) and taurursodiol, would slow or mitigate the neurodegeneration caused by PSP.
After AMX0035 did not show differences compared to the placebo on primary and secondary outcomes at week 24, it was decided the trial should be discontinued. And a Phase 3 portion of the trial will not be initiated as planned.
We understand this maybe disappointing news for PSPA supporters however Amylyx Pharmaceutical have reassured families, saying “We believe data from this trial will inform PSP literature as well as deepen scientific understanding of this devastating disease.”
The full press release from Amylyx Pharmaceuticals can be read, here.
