Press release
Fulcrum Therapeutics Announces Second Quarter 2022 Financial Results and Business Update
Presented initial data from Phase 1b trial in sickle cell disease (SCD), which demonstrate rapid and robust increases in hemoglobin F (HbF); supports
About this update from Fulcrum Therapeutics, Inc.
[{"type":"text","content":"Presented initial data from Phase 1b trial in sickle cell disease (SCD), which demonstrate rapid and robust increases in hemoglobin F (HbF); supports proof-of-concept that FTX-6058 is a novel oral HbF inducerAnnounced enrollment of first patient in Phase 3 REACH trial of losmapimod in facioscapulohumeral muscular dystrophy (FSHD); first ever Phase 3 trial in this diseaseAnnounced strategic realignment to reduce operating expenses by $40-50M, prioritize clinical execution, and extend cash runway into mid-2024Conference call scheduled for 8:00 a.m. ET today CAMBRIDGE, Mass., Aug. 11, 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 reported financial results for the second quarter of 2022 and announced a strategic plan to realign internal resources to support the two clinical programs that are expected to be the key drivers of near-term value and extend cash runway. “In the second quarter, we achieved major milestones in both of our clinical programs,” said Bryan Stuart, Chief Executive Officer of Fulcrum Therapeutics. “We demonstrated compelling proof of concept data for 6058 and initiated the first registrational trial for FSHD. Our strategic refocus will better position us to continue to advance our exciting pipeline and deliver on our unwavering commitment to patients with genetically defined rare diseases.” Key Business Updates FTX-6058 Announced data from initial patients in first cohort of Phase 1b trial of FTX-6058 in SCD; achieved HbF increases of up to 6.3% over baseline, showing proof-of-concept for FTX-6058 as an oral HbF inducer.Enrolling new patients in 6mg and 2mg dose cohorts of Phase 1b SCD trial, including patients both on and off hydroxyurea.Planning to initiate additional cohort at higher dose; expect to complete enrollment in three dose cohorts by end of 2022.Planning to initiate registrational trial in 2023.Delaying initiation of Phase 1b trial in non-SCD hemoglobinopathies, including beta-thalassemia. Losmapimod Enrolled first patient in REACH pivotal Phase 3 trial in FSHD.Registrational trial will include over 30 sites in the U.S., EU, U.K., and Canada. Preclinical Pipeline Planning to submit next Investigational New Drug application (IND) in 2023. Organizat...