FDA Grants Orphan Drug Designation to new Treatment for Duchenne Muscular Dysptrophy (DMD)
Food and Drug Administration (FDA) has granted Orphan Drug designation and Rare Pediatric Disease designation to ARM210 (also known as S48168) for the treatment of Duchenne Muscular Dystrophy (DMD). DMD is a rare form of muscular dystrophy that presents as a progressive and debilitating weakening of muscles in young males. The announcement was made by Armgo Pharma.
The Phase 1 clinical trial for ARM210 has begun. This will assess its safety and pharmacokinetics in healthy male subjects. Armgo intends to initiate a Phase 2a study on subjects with DMD following the successful completion of the Phase 1 trial.
ARM210 (S48168) is an oral Ryanodine Receptor (RyR) agonist.
For more information visit Armgo.com.