Fulcrum Seeks to Initiate the P-III (REACH) Trial of Losmapimod for the Treatment of Facioscapulohumeral Muscular Dystrophy
Shots:
- The company initiates the P-III (REACH) trial to evaluate losmapimod (15mg, bid, PO) vs PBO in a ratio (1:1) in 230 adult patients with FSHD for 48wk. The trial is expected to be initiate in Q2’22
- The 1EPs of the study is the absolute change from baseline in RWS & 2EPs include MFI, PGIC & Neuro QoL UE. The trial also include patient-centered assessments of healthcare utilization
- In the P-IIb (ReDUX4) trial, the patients treated with losmapimod achieved the slowed disease progression, clinical benefits on multiple measures of muscle health, function along with PROs & showed clinical benefit. The therapy also decreased progression of fat infiltration in muscles
Ref: Globenewswire| Image: Fulcrum
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