Last week, Amylyx published news about their Orion clinical trial which was due to introduce UK testing sites during 2024.
Unfortunately, the Medicines and Healthcare products Regulatory Agency (MHRA) has not accepted the clinical trial application from Amylyx of protocol A35-009, a Phase 3 study of safety and efficacy of AMX0035 in Progressive Supranuclear Palsy (PSP). As such, the initiation of the study in the UK is unable to proceed at this time.
PSPA CEO, Rebecca Packwood, said: “We know many of our supporters will be incredibly disappointed to hear the Orion trial will not be going ahead in the UK at this time. Whilst the trial isn’t going ahead in the UK, it is continuing in America, Japan and in Europe which means Amylyx will still be testing their protocol and gathering data about its use.
“Research into PSP & CBD has gathered pace in the last ten years, and we do know so much more about the condition than before. We know there is still a lot to learn, which is why in 2024 PSPA has increased its investment in research and continues to work closely with researchers and pharmaceutical companies to help develop more interest in the conditions and further trials to help improve quality of life for people diagnosed with PSP or CBD.”
