Posted by Friends of FSH Research on May 13, 2020
Michelle Hage (Fulcrum Therapeutics)
Today Fulcrum issued a press release that provided an update on our business, including the steps we are taking to adapt in response to the challenges presented by COVID-19. In collaboration with our trial investigators, and to provide the highest levels of protection and convenience for patients and clinicians, we have made some changes to the ReDUX4 study for FSHD. These changes are designed to enable patients and investigators to continue participation in the trial, and for us to monitor patient safety as we collect essential data to advance this important study.
The biggest change is that we have amended the study to extend the randomized, placebo-controlled part of the trial from 24 to 48 weeks. Patients enrolled in the trial will still have the opportunity to participate in the open label extension after completing the week 48 visit. This amendment also allows for a second biopsy to occur at either 16 weeks or at 36 weeks if a biopsy could not be performed at 16 weeks due to COVID-19. We strongly believe these changes are in the best interest of the FSHD community and we are grateful for your patience and ongoing partnership.
See full news release.