Press release
Fulcrum Therapeutics Reports Recent Business Highlights and Fourth Quarter and Full Year 2019 Financial Results
Conference call scheduled for 8:00 a.m. ET today CAMBRIDGE, Mass., March 05, 2020 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. (Nasdaq: FULC), a
About this update from Fulcrum Therapeutics, Inc.
[{"type":"text","content":"Conference call scheduled for 8:00 a.m. ET today\nCAMBRIDGE, Mass., March 05, 2020 (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 fourth quarter and full year of 2019.\n “We made important progress at a rapid pace in 2019 as we transitioned from a private, discovery company into a public, clinical-stage company,” said Robert J. Gould, president and chief executive officer. “In our losmapimod program for patients with facioscapulohumeral muscular dystrophy (FSHD), we completed enrollment in our Phase 2 clinical trials, including ReDUX4, the randomized, double-blind placebo-controlled multicenter international Phase 2b clinical trial, and we continue to expect to announce topline data on the primary endpoint in the third quarter of 2020. We also plan to submit an IND for FTX-6058 for the treatment of sickle cell disease in the second half of this year. We look forward to building on this progress as we execute on our goal of advancing therapies focused on improving the lives of patients with genetically defined diseases.” Recent Business Highlights Evidence of dose-dependent target engagement observed in skeletal muscle with losmapimod in Phase 1. Builds on previously announced dose-dependent pharmacokinetics and target engagement in blood. Completed patient enrollment in ReDUX4 Phase 2b trial of losmapimod, a selective p38α/β mitogen activated protein kinase (MAPK) inhibitor. Phase 2 Open Label Study also completed enrollmentReDUX4 open label extension initiatedRemain on track to report topline data in the third quarter of 2020 Received U.S. Orphan Drug Designation for losmapimod in FSHD.Presented Phase 1 clinical data at the World Muscle Society meeting highlighting the safety, tolerability, and target engagement of losmapimod for the treatment of FSHD.Plan to submit an investigational new drug application (IND) to the U.S. Food and Drug Administration for FTX-6058 in the second half of 2020. FTX-6058 is an oral small molecule therapeutic discovered by Fulcrum and designed to induce expression of fetal hemoglobin (HbF) in red blood cells to compensate for the mutated adult beta hemoglobin in sickle cell disease. Expand...