On March 19, 2024, Seelos Therapeutics, Inc., a clinical-stage biopharmaceutical company, announced top-line results from its Phase 2/3 HEALEY ALS Platform trial evaluating SLS-005 (IV Trehalose) for Amyotrophic Lateral Sclerosis (ALS). The study, in collaboration with The Sean M. Healey and AMG Center, did not meet statistical significance in the primary and secondary endpoint in the Full Analysis Set. However, a potential signal of efficacy was observed in a pre-specified subgroup, showing a 22% improvement in the ALS Functional Rating Scale (ALSFRS-R) and a 25% slowing of Slow Vital Capacity (SVC) decline. Seelos plans to request a meeting with the FDA to discuss the program's future and will continue discussions with potential partners. The full dataset is yet to be...Show More

On March 19, 2024, Seelos Therapeutics, Inc., a clinical-stage biopharmaceutical company, announced top-line results from its Phase 2/3 HEALEY ALS Platform trial evaluating SLS-005 (IV Trehalose) for Amyotrophic Lateral Sclerosis (ALS). The study, in collaboration with The Sean M. Healey and AMG Center, did not meet statistical significance in the primary and secondary endpoint in the Full Analysis Set. However, a potential signal of efficacy was observed in a pre-specified subgroup, showing a 22% improvement in the ALS Functional Rating Scale (ALSFRS-R) and a 25% slowing of Slow Vital Capacity (SVC) decline. Seelos plans to request a meeting with the FDA to discuss the program's future and will continue discussions with potential partners. The full dataset is yet to be received by Seelos, which will be used for further analyses. SLS-005 was generally well-tolerated, with an imbalance of deaths/death equivalents observed, all deemed unrelated to the study drug. Seelos Therapeutics is focused on developing therapies for CNS disorders and rare diseases, with a portfolio including late-stage clinical assets targeting various conditions.