Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CNM-Au8 · 1 trial · 1 indication
Change in disease severity as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R) total score using a Bayesian repeated measures model that accounts for loss to follow-up due to mortality. 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 |
|---|---|---|
| CNM-Au8 | EXPERIMENTAL | Drug: CNM-Au8 Administration: Oral Dosage: 30 mg or 60 mg daily |
| Matching Placebo | PLACEBO_COMPARATOR | Administration: Oral Dosage: 2 bottles daily |
| Name | Type | Description |
|---|---|---|
| CNM-Au8 | DRUG | Drug: CNM-Au8 Administration: Oral Dosage: 30 mg or 60 mg daily |
| Matching Placebo | DRUG | Drug: Matching Placebo Administration: Oral Dosage: 2 bottles daily |
Inclusion Criteria: * No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT NCT04297683). Exclusion Criteria: * The following exclusion criterion is in addition to the exclusion criteria specified in the Master Protocol (NCT NCT04297683). 1. Histo...
CNM-Au8 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 is not yet approved by regulatory authorities.
CNM-Au8 is being developed by Merit Medical Systems, Inc., a company publicly traded under the ticker symbol MMSI. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with ALS.
CNM-Au8 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being evaluated in a completed Phase 2 trial for Amyotrophic Lateral Sclerosis.
CNM-Au8 was studied in a Phase 2 clinical trial with the identifier NCT04414345, titled "HEALEY ALS Platform Trial - Regimen C CNM-Au8." This randomized, double-blind, placebo-controlled trial enrolled 161 participants with Amyotrophic Lateral Sclerosis in the United States and has been completed.
CNM-Au8 is not known to have alternative names. It is a distinct investigational small molecule being developed by Merit Medical Systems, Inc. for the treatment of Amyotrophic Lateral Sclerosis.