ATyr Pharma has announced that Resolaris, an investigational treatment of facioscapulohumeral muscular dystrophy (FSHD), has been granted Fast Track status by the Food and Drug Administration (FDA).

Resolaris, a first-in-class intravenous protein therapeutic derived from a naturally occurring protein released in vitro by human skeletal muscle cells, is the first FSHD treatment to receive Fast Track designation. FSHD is a rare genetic myopathy that affects an estimated 19,000 people in the United States for which there are no approved treatments. 

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A Phase 1b/2 clinical study of Resolaris is currently being conducted for three types of rare myopathies with an immune component; in patients with early-onset FSHD (003 trial), in patients with FSHD and Limb Girdle Muscular Dystrophy 2B (LGMD2B, 004 trial), and an extension study in FSHD patients (005 trial). 

“This designation highlights the significant need to develop and ultimately approve meaningful new therapeutics to treat patients with rare myopathies, such as FSHD,” said John Mendlein, PhD, CEO of aTyr Pharma.

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