Fulcrum’s Phase 3 Clinical Trial Has Launched
This past summer, the Phase 3 clinical trial for Losmapimod began. It is an experimental FSHD treatment. Patients diagnosed with FSHD 1 and FSHD 2 will participate in this study for approximately 53 weeks. Patients will be randomized to receive 15 mg of losmapimod or placebo twice daily by mouth for 48 weeks. Source
Losmapimod is an investigational, selective p38α/β mitogen-activated protein kinase (MAPK) inhibitor. Fulcrum discovered the role of p38α/β inhibitors in reducing DUX4 expression and an extensive review of known compounds. The results reported slowed disease progression and improved function, including positive impacts on upper extremity strength, supporting losmapimod’s potential to be a transformative therapy for the treatment of FSHD.
– REACH is the first Phase 3 trial for this rare, progressive, and debilitating muscular disease –
– Losmapimod is a small oral molecule that has the potential to be the first therapy to treat FSHD, the second most common form of muscular dystrophy –
– U.S. Food and Drug Administration (FDA) granted Fast Track Designation in 2021 –
Read more about it here: Fulcrum Therapeutics
If you have FSHD, what do you think of this Phase 3 clinical trial? Does it give you hope that there will be treatment by 2025 when the FSHD Society said they would have one?
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