Ticker | Status | Jurisdiction | Filing Date | CP Start | CP End | CP Loss | Deadline |
---|
Ticker | Case Name | Status | CP Start | CP End | Deadline | Settlement Amt |
---|
Ticker | Name | Date | Analyst Firm | Up/Down | Target ($) | Rating Change | Rating Current |
---|
Tuesday, Seelos Therapeutics Inc (NASDAQ:SEEL) provided an update on top-line data of the Phase 2/3 HEALEY ALS Platform trial.
The study was designed to evaluate SLS-005 (IV trehalose), a low molecular weight disaccharide that stabilizes misfolded proteins and activates autophagy, in decreasing the slope of the ALS Functional Rating Scale (ALSFRS-R) and separation from placebo in Function and Mortality in an all-comers population of Persons with ALS (PALS).
The company said that while the study did not meet statistical significance in the primary and secondary endpoint in the Full Analysis Set (FAS), it showed a 13% improvement in Function and Mortality with an 88% success probability (versus the pre-specified 98%), a potential signal of efficacy in a pre-specified subgroup (ERF).
In the pre-specified subgroup of PALS treated with SLS-005, without Amylyx Pharmaceuticals Inc (NASDAQ:AMLX) Relyvrio, the top-line data favored SLS-005 versus placebo in efficacy measures in the Efficacy RELYVRIO Free (ERF) data set (n=130), including:
Seelos awaits receiving full data sets and it plans to run additional analyses, including biomarkers of neurodegeneration, neurofilament light chain, exploratory efficacy results, subgroups, and post-hoc analyses.
SLS-005 was generally well-tolerated and comparable to placebo in safety.
Price Action: SEEL shares are down 54.2% at $0.42 on the last check Tuesday.
Photo via Shutterstock