Seelos Therapeutics Wins Orphan Drug Status for ALS Treatment

N.Y.-based Seelos Therapeutics has received an Orphan Drug designation from the FDA for its amyotrophic lateral sclerosis (ALS) therapy SLS-005.  

Seelos said it will enroll 160 ALS patients in a randomized, placebo-controlled phase 2/3 study to evaluate the drug’s effectiveness at 24 weeks, including any changes in disease progression.

The drug previously received Orphan Status from the FDA and the European Medicines Agency for other muscular degenerative diseases, including a form of muscular dystrophy.