Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SLS-005 · 1 trial · 1 indication
Change in disease severity over time as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R). Each type of function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Patients with higher scores have more physical function.
Mortality is defined as death or death equivalent. A participant is determined to meet the criteria of death equivalent if permanent assisted ventilation (PAV) is used for more than 22 hours per day for more than seven days in a row. The rate of mortality was estimated from a Bayesian shared-parametric model that assumed exponentially distributed survival times.
| Arm | Type | Description |
|---|---|---|
| SLS-005 | EXPERIMENTAL | SLS-005 is administered via infusion once weekly for 24 weeks. |
| Matching Placebo | PLACEBO_COMPARATOR | Matching placebo is administered via infusion once weekly for 24 weeks. |
| Name | Type | Description |
|---|---|---|
| SLS-005 | DRUG | Administration: Infusion Dose: 0.75 g/kg weekly |
| Matching Placebo | DRUG | Administration: Infusion Dose: equivalent weight-based volume as described for trehalose |
Inclusion Criteria: * No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT NCT04297683). Exclusion Criteria: * The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT NCT04297683). 1. Curre...
SLS-005 is an investigational small molecule being studied for the treatment of amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disease. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
SLS-005 is a small molecule, but its specific molecular target has not been disclosed. It is being evaluated in a placebo-controlled, double-blind Phase 2 trial for ALS, with biomarker selection used to identify participants.
SLS-005 is being developed by Merit Medical Systems, Inc., a company traded on the NASDAQ under the ticker symbol MMSI. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with ALS.
SLS-005 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory bodies. Its Phase 2 trial has been completed, and the drug remains under investigation for ALS.
SLS-005 was studied in the HEALEY ALS Platform Trial, Regimen E, under the identifier NCT05136885. This Phase 2, randomized, double-blind, placebo-controlled trial enrolled 161 participants with ALS in the United States and has been completed.
SLS-005 is also known as trehalose, as indicated by the trial title 'HEALEY ALS Platform Trial - Regimen E SLS-005 - Trehalose.' It is a small molecule being investigated for ALS, and the completed Phase 2 trial used this alternative name.