Seelos Therapeutics Shares Gain On FDA Approval To Add SLS-005 Regimen In HEALEY ALS Trial

The Sean M. Healey & AMG Center for ALS at Mass General received approval from the FDA and the Mass General Brigham Institutional Review Board to add SLS-005 (trehalose injection, 90.5 mg/ML for intravenous infusion) as an additional regimen in the HEALEY ALS Platform Trial.
HEALEY ALS Trial Design Committee worked with Seelos Therapeutics Inc SEEL to include SLS-005’s pivotal Phase 2b/3 trial in amyotrophic lateral sclerosis (ALS) on the platform.
The drug received Orphan Drug Designation for ALS from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP).
Trehalose is a low molecular weight disaccharide (0.342 kDa) that crosses the blood-brain barrier, stabilizes proteins and, activates autophagy, which is the process that clears material from cells.
The HEALEY ALS Platform Trial is designed to evaluate multiple investigational treatments simultaneously.
Related content: Benzinga's Full FDA Calendar.
Price Action: SEEL stock is up 20.4% at $2.29 during the market session on the last check Tuesday.