Press release
Fulcrum Therapeutics Announces Recent Business Highlights and Third Quarter 2022 Financial Results
― Selected 12mg as the dose for next cohort in the Phase 1b trial of FTX-6058 in sickle cell disease (SCD) ― ― Presented 96-week data from the Phase 2 ReDUX4
About this update from Fulcrum Therapeutics, Inc.
[{"type":"text","content":"― Selected 12mg as the dose for next cohort in the Phase 1b trial of FTX-6058 in sickle cell disease (SCD) ― ― Presented 96-week data from the Phase 2 ReDUX4 trial open label extension (OLE) study at World Muscle Society (WMS) conference ― ― Completed equity raise of approximately $80.8 million in net proceeds; Updated cash runway guidance into late 2024 ― ― Announced the appointments of Chief Medical Officer and Chief Scientific Officer ― ― Conference call scheduled for 8:00 a.m. ET today ― CAMBRIDGE, Mass., Nov. 08, 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 third quarter of 2022. “In the third quarter, we have continued our focus on strong clinical and operational execution. Now that we have established proof of concept for FTX-6058 as an oral HbF inducer and have initiated our Phase 3 registration-enabling trial in FSHD, the team is focused on progressing our clinical programs and developing high-quality, compelling data,” said Bryan Stuart, president and chief executive officer. “We believe we are well positioned, with a strong cash runway to deliver on our upcoming catalysts as we prepare to have two registration-enabling trials in the next 18 months.” Key Business Updates FTX-6058 Selected 12mg as the dose for the third cohort in the Phase 1b SCD trial; plan to include participants both on and off hydroxyurea.Continuing to enroll patients at both 6mg and 2mg doses.The Phase 1b trial is expected to continue enrolling into 2023. Losmapimod Presented 96-week OLE data from the Phase 2 ReDUX4 trial at the WMS conference in October: 97 percent of participants in the initial 48-week study continued into the OLE.Participants in the initial treatment-arm who continued to receive losmapimod demonstrated maintenance of effect through 96-weeks as measured by reachable workspace (RWS) mean change from baseline.Participants who crossed over from placebo to losmapimod after the initial 48-week trial period showed improvement and slowing of disease progression as measured by RWS mean change from baseline.Losmapimod continued to demonstrate a favorable safety profile and was generally well tolerated. Continuing to enroll patients in REACH Phase 3 pi...