aTyr announced that its candidate Resolaris has been granted Fast Track designation for the treatment of limb girdle muscular dystrophy 2B (LGMD2B), by the Food and Drug Administration (FDA). The FDA also removed its partial clinical hold on a dosing ceiling for Resolaris in clinical trials.

Results from a Phase 1b/2 open-label trial of Resolaris in 9 patients with LGMD2B, showed that 78% (7) of patients had an increase in muscle function at 14 weeks as measured by manual muscle test (MMT). Patients received up to 3mg/kg biweekly, a dose the researchers can be more flexible with in the future due to the ceiling removal. Overall, the trial showed a mean increase of MMT from baseline of 6.2%. 

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Resolaris is a potential first-in-class intravenous protein therapeutic for the treatment of rare myopathies, being developed by aTyr to treat patients with rare myopathies characterized by excessive immune cell activity. 

“We believe that during our safety and dose ranging Phase 1b/2 clinical trials we have potentially identified a dose for the next phase of clinical development with a favorable safety profile and potential clinical activity across different rare muscle indications,” said Sanjay Shukla, MD, MS, and CMO of aTyr. 

The Fast Track decision makes Resolaris the first known therapeutic candidate for the treatment of LGMD2B to receive this designation.

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