Seelos Misses Endpoints in Blow to ALS Community
Biopharmaceutical company, Seelos Therapeutics (Nasdaq: SEEL) has missed primary and secondary endpoints in its Phase 2/3 HEALEY ALS Platform trial of SLS-005 in a blow to the ALS community. The company’s shares dropped by more than 50% to reach a record low in trading last week.
SLS-005 previously received Orphan Drug Designation for the treatment of ALS from the FDA and from the European Medicines Agency in the EU. It was found to be well-tolerated and comparable to placebo in safety, and although it missed a number of endpoints, the compound showed a potential signal of efficacy in a pre-specified subgroup.
In this subgroup of patients treated with SLS-005, without RELYVRIO®, the top-line data favored SLS-005 versus placebo, demonstrating a 22% improvement in slope of change in ALSFRS-R assessment adjusted for mortality, with an 89% success probability, at 24 weeks, and a 25% slowing of Slow Vital Capacity (SVC) decline versus placebo.
“The HEALEY platform is designed to detect signals of efficacy and we believe the observed signal and success probability is competitive to other recently FDA-approved therapies for ALS which also failed to achieve statistical significance when measured for function and mortality on similar primary and efficacy endpoints,” said Raj Mehra Ph.D., Chairman and Chief Executive Officer of Seelos. “We plan to request a meeting with the FDA to discuss potential next steps for the program and will continue our potential partner discussions.”
Seelos plans to run additional analyses once it receives the full dataset, including examining biomarkers of neurodegeneration, neurofilament light chain, exploratory efficacy results, subgroups and post-hoc analyses.
About Seelos Therapeutics
Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (CNS) disorders and other rare diseases. The Company’s robust portfolio includes several late-stage clinical assets targeting indications including Acute Suicidal Ideation and Behavior (ASIB) in Major Depressive Disorder (MDD), amyotrophic lateral sclerosis (ALS) and spinocerebellar ataxia (SCA), as well as early-stage programs in Huntington’s disease, Alzheimer’s disease, and Parkinson’s disease.
