Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced results from the placebo group analyses of the ADAGIO study (Attenuation of Disease progression with AZILECT® GIven Once-daily) that were presented at the 62nd Annual Meeting of the American Academy of Neurology (AAN). The ADAGIO study stands out from other Parkinson's disease (PD) trials as it is the largest clinical study conducted in patients who were still in the very early stages of their disease course (average time from PD diagnosis of 4.5 months).
The placebo analyses demonstrated that the natural progression of clinical symptoms in PD may be slower in the earlier stages of disease development than was expected from previous findings. These results may have implications for the overall interpretation of the ADAGIO results. Specifically, the clinical significance of the 1.7 UPDRS (Unified Parkinson's Disease Rating Scale) units seen between the AZILECT® (rasagiline tablets) 1 mg/day early and delayed-start groups during the nine month time period represents, on average, a 40 percent reduction from baseline in the early group when compared to the delayed group.
The results of the subgroup analysis showed faster progression in placebo patients with the highest baseline UPDRS scores (upper quartile), which may provide an explanation for the reported ability to detect a larger magnitude of disease-modifying effect with AZILECT® in ADAGIO patients in this subgroup.
"One interpretation about what was found in the subgroup analyses of placebo patients with the highest UPDRS scores is that the faster progression of these patients may explain the previously reported ability to detect a larger magnitude of disease modifying effect in this population, as well as a significant effect for the 2 mg dose," said Olivier Rascol, MD, University UPS, Toulouse, France, the co-principal investigator of the ADAGIO study.
Teva Pharmaceutical Industries Ltd.