Losmapimod for FSHD Program Update

Posted by Friends of FSH Research on Apr 2, 2020

Fulcrum Therapeutics Provides Business Update on Impact of COVID-19

As a result of the suspension of clinical-trial activity by a number of the Company’s clinical trial sites stemming from the pandemic, the Company is currently assessing the impact to the ReDUX4 clinical trial, including whether it will have topline data for the primary endpoint by the end of the third quarter of 2020 as previously disclosed. The company plans to provide a further update when it has more clarity. ReDUX4 is an international, multicenter, randomized, Phase 2b double-blind, placebo-controlled, 24-week trial of losmapimod in 80 patients with genetically confirmed facioscapulohumeral muscular dystrophy (FSHD).

Q&A

When does Fulcrum anticipate knowing specifically how clinical trials and timelines will be affected?

• Fulcrum is continuing to monitor developments related to COVID-19 carefully and will provide updates as early as possible.

Will losmapimod continue to be available for patients in the OLE study?

• At this time, Fulcrum does not anticipate any changes in availability of losmapimod or the ability to expand production as needed. Fulcrum will continue to monitor patient safety closely, as well as minimize treatment disruptions.

When will losmapimod be available to patients?

• The team at Fulcrum is dedicated to advancing this development program as rapidly as possible.

Is it possible to continue to monitor patients remotely?

• Fulcrum is working with trial sites to try to identify opportunities for remote patient monitoring and will provide an update when they’re able regarding these strategies.

How far along is Fulcrum in the study?  If enrollment in the trial is finished, why would data be late?

• The completion of enrollment was announced in February 2020.
• A number of Fulcrum’s clinical trial sites have temporarily postponed clinical trial related activities.  Fulcrum is currently assessing the impact this will have on ReDUX4 and will provide an update when they have more clarity.

Will any patients need to restart their participation in the trial? 

• Fulcrum is currently considering different scenarios and will provide an update as soon as they have more clarity.

Is there a protocol or data related to patients who stop and then restart treatment with losmapimod in the trial?

• Fulcrum is currently considering different scenarios and will provide an update as soon as they have more clarity.