NEW YORK - Seelos Therapeutics, Inc. (NASDAQ: NASDAQ:SEEL), a clinical-stage biopharmaceutical company, today announced preliminary findings from its Phase 2/3 HEALEY ALS Platform trial, which did not meet the primary and secondary endpoints but showed a potential signal of efficacy in a specific subgroup of patients.
The study evaluated SLS-005, an investigational treatment for amyotrophic lateral sclerosis (ALS), in a broad population of patients.
The trial's primary measure was the change in the ALS Functional Rating Scale (ALSFRS-R) slope, assessing function and mortality.
While the overall results did not achieve statistical significance, a pre-specified subgroup of patients not treated with the drug RELYVRIO® exhibited a 22% improvement in the ALSFRS-R slope and a 25% reduction in the decline of Slow Vital Capacity (SVC), both key measures of ALS progression.
Seelos plans to request a meeting with the FDA to discuss the program's future and will continue discussions with potential partners. The company is awaiting the full dataset to conduct further analyses, including biomarkers and exploratory efficacy results.
SLS-005 was generally well-tolerated with safety comparable to placebo, though an imbalance in deaths/death equivalents was noted, deemed unrelated to the drug.
SLS-005, a low molecular weight disaccharide, has received Orphan Drug Designation for ALS treatment but is not yet approved for medicinal use. ALS is a rare neurological disease leading to progressive muscle weakness and is currently without a cure or effective treatment to halt or reverse progression.
The findings, based on a press release statement from Seelos, contribute to ongoing research in the field of ALS, where the need for effective therapies remains high.
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