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AMRA’s quantitative whole-body MRI analysis used in the ReDUX4 clinical trial.
LINKÖPING, Sweden, July 14, 2021 — AMRA announced today that its magnetic resonance imaging (MRI) based method has sufficient sensitivity to detect disease progression at the muscular level in ReDUX4: a multicenter Phase 2b clinical trial testing the safety and efficacy of Losmapimod in treating facioscapulohumeral muscular dystrophy (FSHD). The study introduced a powerful new method in MR image analysis, delivering a new paradigm in neuromuscular disease clinical trials for clinical researchers to consider.
AMRA’s quantitative measures for evaluating muscle health, including muscle fat infiltration to volumetrically evaluate the amount of fat within functional muscles, were used in ReDUX4. The clinical trial, launched by Fulcrum Therapeutics in 2019, enrolled 80 patients across 17 sites in 4 countries including the United States. Participants in the ReDUX4 trial were assessed with quantitative full body, whole muscle MRI, providing a holistic understanding of what is going on inside the muscles. Recently announced by Fulcrum, Losmapimod-treated participants showed decreased disease progression in the composite measure of muscle fat infiltration as measured in intermediate muscles (those most likely to change).
“We are thrilled about the ReDUX4 results. Not only do they propel a potential treatment forward for people living with FSHD, but the reduction in muscle fat infiltration and correlating benefit with several other measures reflects the power of our MRI-based muscle assessment methods in neuromuscular disease clinical trials. We are excited to bring these benefits to other teams to help them push their research forward and address the needs of these devastating diseases,” said Eric Converse, CEO of AMRA Medical.
AMRA’s advanced MRI methods and analysis can potentially help detect changes prior to individuals experiencing functional difficulties. This is particularly powerful when paired in clinical trials with functional outcome assessments, such as the Timed Up and Go (TUG), in clinical trials because researchers can assess disease severity at multiple levels and connect it to FSHD-relevant clinical endpoints. Further, AMRA’s whole muscle MR imaging and analysis, proximal to distal, in the whole body, led to a personalized set of muscles to follow over time, enabling researchers to capture disease heterogeneity—a longstanding challenge in neuromuscular disease research.
Setting a new standard in neuromuscular disease research, the ReDUX4 results demonstrate how MRI advancements can detect pathological changes in muscle, providing critical information about disease severity, disease progression, and the effect of a drug on muscle health.