Fulcrum Therapeutics Inc (NASDAQ:FULC) plans to initiate REACH, a Phase 3 trial of losmapimod in facioscapulohumeral muscular dystrophy (FSHD), in Q2 of 2022.
- FSHD is characterized by fat infiltration of skeletal muscle leading to muscular atrophy involving the face, scapula and shoulders, upper arms, and abdomen.
- REACH will be a randomized, double-blind, placebo-controlled, multi-national trial to evaluate the efficacy and safety of losmapimod for the treatment of FSHD.
- The trial is expected to enroll approximately 230 adults with FSHD. Patients will be randomized 1:1 to receive either losmapimod, administered orally as a 15 mg tablet twice a day, or placebo, and evaluated over a 48-week treatment period.
- The study's primary endpoint is the absolute change from baseline in Reachable Workspace (RWS).
- The Company plans to report initial data from the Phase 1b trial of FTX-6058 in sickle cell disease in Q2 of 2022.
- Earnings: Fulcrum ended FY21 with cash, cash equivalents, and marketable securities of $218.2 million.
- The Company reported Q4 collaboration revenues of $5.06 million, up 19.7%, beating the consensus of $ $2.68 million.
- It reported a narrower EPS loss of $(0.58), compared to $(0.64) a year ago and the consensus of $(0.73).
- Price Action: FULC shares are down 6.40% at $10.39 during the market session on the last check Thursday.
