Phase 3 Fulcrum Clinical Trial in FSHD Using Whole Body MRI Measurements from AMRA Medical as a Key Secondary Endpoint

FSHD is a progressive and debilitating neuromuscular disease for which there is no approved treatment. The disease is characterized by fatty infiltration of skeletal muscle, impacting the patient’s ability to perform daily tasks and live independently. Losmapimod is the first and only investigational drug in clinical development, and with positive data, REACH could serve as the basis for approval.

REACH is a multinational, randomized, double-blind, placebo-controlled trial expected to enroll approximately 230 adults with FSHD. Patients will receive either losmapimod or a placebo, and will be evaluated over a 48-week treatment period. AMRA’s MRI protocol will be used to produce a composite muscle fat infiltration (MFI) score for each patient as a secondary endpoint, with accessible workspace (RWS) as the primary endpoint.

This is not the first time that Fulcrum has used AMRA’s measurements. AMRA and Fulcrum have partnered with MRI in their studies of losmapimod from early biomarker development through the ReDUX4 phase 2b, and now in the REACH phase 3 trial. The ReDUX4 trial, which demonstrated that losmapimod slowed disease progression and improved function in people with FSHD, found that RWS and MFI are reliable measures of disease progression. This has led EU and US regulatory agencies, including the FDA, to support the use of MFI composite scores in REACH.

The MFI composite score can help describe specific aspects of disease onset patterns, functional impairment, and disease progression between examinations. Scores are generated following a whole-body, whole-muscle MRI by combining measurements of muscle fat infiltration from multiple muscles throughout the body. By converting all of the IMF data for a given individual into a simplified score, researchers gain meaningful information that is easier to interpret than trying to draw conclusions from 36 different measures of IMF for a given individual. , not to mention all of the 230 study participants. With AMRA, researchers can observe significant differences in functional (RWS) and imaging (MFI) parameters to gain more holistic insights and ultimately advance their clinical pipeline.

The losmapimod journey demonstrates that progressive pharmaceutical companies can gain valuable insights from AMRA’s MRI-based body composition measurements when used in proof-of-concept studies through clinical trials of advanced stage. Find out how AMRA can help you advance metabolic and musculoskeletal clinical research and development by visiting AMRA’s website.


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