Press release
Fulcrum Therapeutics® Reports Recent Business Highlights and Third Quarter 2021 Financial Results
–On-track to initiate enrollment by year-end in Phase 1b clinical trial of FTX-6058 in people with sickle cell disease– – Losmapimod update planned for Q1
About this update from Fulcrum Therapeutics, Inc.
[{"type":"text","content":"–On-track to initiate enrollment by year-end in Phase 1b clinical trial of FTX-6058 in people with sickle cell disease– – Losmapimod update planned for Q1 2022 – –Raised $144.2 million in gross proceeds from August 2021 public offering, extending cash runway into 2024 – – Conference call scheduled for 8:00 a.m. ET today – CAMBRIDGE, Mass., Nov. 04, 2021 (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 third quarter of 2021. “Fulcrum made great progress in the third quarter, as we continued to advance our lead programs for FSHD and sickle cell disease,” said Bryan Stuart, president and chief executive officer. “Most notably, we reported compelling data from our Phase 1 trial of FTX-6058 that strengthen our belief in its potential as a functional cure for people with sickle cell disease and other hemoglobinopathies. Based on these data demonstrating proof-of-biology in healthy adults, we are moving quickly into a Phase 1b trial in people with sickle cell disease and plan to submit an investigational new drug application for FTX-6058 in other hemoglobinopathies, including beta thalassemia, by the end of this year. We are equally excited about losmapimod, which we believe has the potential to slow or stop the progression of FSHD, and we look forward to sharing next steps following our regulatory interactions. Looking ahead, we are well-funded with cash into 2024 beyond multiple expected milestones that bring us closer to our goal of delivering life-changing therapies to people with rare genetic diseases.” Upcoming Milestones Initiate enrollment in a Phase 1b clinical trial of FTX-6058 in people with sickle cell disease by year-end 2021.Submit an investigational new drug application (IND) for FTX-6058 in non-sickle cell disease hemoglobinopathies, including beta thalassemia, by year-end 2021.Report an update from the ongoing Phase 1 trial of FTX-6058, including data from the 20mg and 30mg multiple-ascending dose (MAD) cohorts in healthy volunteers, by year-end 2021. In conjunction with the update, report new data for FTX-6058 further elucidating the relationship between EED inhibition and HBG mRNA induction.Meet with health a...