Press release
Fulcrum Therapeutics Reports Recent Business Highlights and First Quarter 2022 Financial Results
– Initial data from Phase 1b trial of FTX-6058 in sickle cell disease to be presented at the EHA 2022 Congress – – Phase 3 REACH trial of losmapimod in FSHD
About this update from Fulcrum Therapeutics, Inc.
[{"type":"text","content":"– Initial data from Phase 1b trial of FTX-6058 in sickle cell disease to be presented at the EHA 2022 Congress – – Phase 3 REACH trial of losmapimod in FSHD expected to begin in 2Q 2022 – – Conference call scheduled for 8:00 a.m. ET today – CAMBRIDGE, Mass., May 09, 2022 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today provided a business update and reported financial results for the first quarter of 2022. “Our clinical programs continued to make significant progress in the first quarter,” said Bryan Stuart, president and chief executive officer. “Looking ahead, we are sharing initial data from the ongoing 6 mg dose cohort in the Phase 1b trial of FTX-6058 in people with sickle cell disease at the EHA Congress, and we plan to open the next dose cohort in the trial in the second quarter. Additionally, we plan to begin dosing patients in REACH, our Phase 3 trial of losmapimod in FSHD, in the second quarter. We are in a strong financial position to continue to execute on these programs, both of which have the potential to be life-changing, while continuing to leverage our FulcrumSeek™ product engine to expand our pipeline and fuel our long-term growth.” Upcoming Milestones FTX-6058 Report initial data, including measures of HbF protein induction and safety, from the ongoing 6 mg dose cohort in the Phase 1b trial in people with sickle cell disease at the European Hematology Association (EHA) 2022 Hybrid Congress, taking place from June 9-12, 2022.Open next dose cohort in Phase 1b trial in people with sickle cell disease in the second quarter of 2022.Initiate registrational trial in sickle cell disease in early 2023.Initiation of Phase 1b trial in select other hemoglobinopathies, including beta-thalassemia, now expected in the second half of 2022. Losmapimod Initiate REACH, a Phase 3 randomized, double-blind, placebo-controlled multi-national trial that will evaluate the efficacy and safety of losmapimod for Facioscapulohumeral Muscular Dystrophy (FSHD), in the second quarter of 2022. 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 o...