Following the completion of the Phase 2 clinical trial, Fulcrum therapeutics recruited its first patient for REACH – the Phase 3 clinical trial of losmapimod for facioscapulohumeral muscular dystrophy (FSHD).
REACH is a randomised, placebo-controlled, and multi-national clinical trial, that has been designed to test the safety and efficacy of losmapimod. Losmapimod is a drug that has shown to slow down disease progression in people with FSHD.
This clinical trial will be conducted across 30 sites in Europe and North America and aims to enrol about 230 adults. We will update this story once we know if/where UK sites will be recruiting patients. It is designed to support both the European Medicines Agency (EMA) and the US FDA regulatory applications of losmapimod for the treatment of FSHD. We hope that the data will also support an application to the UK regulator.
We know that this news will be really encouraging for people living with FSHD. And we know that people with FSHD will be hoping that they can access this drug through the NHS soon. However, before this can happen, the company will need to have results from the REACH study and have discussions with the UK regulators – The Medicines and Healthcare products Regulatory Agency (MHRA). They will also need to apply to the UK organisations that recommend whether a treatment is cost-effective to the NHS – NICE and the Scottish Medicines Consortium (SMC).
Read the full press release here.