In this phase II trial, investigators will assess the efficacy, safety and tolerability of Avicena's ALS-08 drug candidate in separate combinations with two treatments, minocycline and celecoxib.
The study design uses a two-stage protocol to determine a superior combination drug candidate. Following treatment, investigators will assess the mean difference in the two treatments. After trial completion, the superior combination therapy will be selected for further study in a phase III clinical trial.
“The unique study design allows for an effective assessment of the neuron-protective potential of ALS-08 in combination with two separate agents that have shown to influence different mechanisms of neurodegeneration,” said CEO Belinda Tsao-Nivaggioli.
Investigators will also assess whether the combination drug candidates are safe and well tolerated in conjunction with riluzole, the only FDA-approved ALS drug.