Evaluate PU-AD in Subjects With Amyotrophic Lateral Sclerosis

Summary

This is a multicenter, Phase 2a, randomized, double-blind, placebo-controlled pilot study to assess the biological activity, safety and pharmacokinetics of PU-AD compared to placebo in ALS. It will be conducted in approximately 20 sites in the US. Approximately 30 subjects will be enrolled in this study; subjects will be randomized 3:2 to receive either PU-AD 30 mg or matching placebo qd, added onto any current stable background treatment.

Timeline

Start

2023-01

Primary completion

2024-12

Completion

2025-01

Outcome

Outcome not reported

Stopped: “Samus Therapeutics company closure”

Drugs

Indications