The Phase II trial evaluated the neuroprotective capacity of two combinations, AL-08 and minocycline versus AL-08 with celecoxib, using group sequential design and a natural history control group for a futility analysis. The primary objective of the trial was selection of a treatment based on which drug combination appeared to slow deterioration in the amyotrophic lateral sclerosis (ALS)-functional score.
Results showed that patients taking the AL-08/celecoxib combination showed a smaller mean decline in ALS-functional score compared to those taking the AL- 08/minocycline combination. Results also showed that the AL-08/celecoxib combination was non-futile compared to historical controls, and merits further evaluation. The company said that the trial was concluded ahead of schedule after the first pool of patients met the selection criteria.
Belinda Nivaggioli, CEO and chairman of Avicena, said: “We are pleased that AL-08/celecoxib slowed deterioration in ALS-functional score compared to the other treatment and believe that results of this trial highlight the potential of this combination treatment for ALS patients. We are eager to proceed with designing our Phase III clinical trial which will attempt to confirm the efficacy of AL-08.”