Clinical Data
The data, which were previously presented as part of a late-breaking oral session at the 13th​ International Conference on Alzheimer's and Parkinson's Diseases (AD/PD) in Vienna, Austria in April 2017, demonstrated that PRX002/RG7935 was found to have an acceptable safety and tolerability profile in patients with Parkinson's disease, meeting the primary objective of this study. CNS penetration was demonstrated by a dose-dependent increase in PRX002/RG7935 levels in CSF, and a mean concentration of PRX002/RG7935 in CSF of 0.3 percent relative to serum across all dose levels. Additional results showed a rapid, dose- and time dependent mean reduction of free serum alpha-synuclein levels of up to 97 percent after a single dose, which were statistically significant (p<0.0001), and maintained following two additional monthly doses. The study results supported advancing PRX002/RG7935 into the PASADENA Phase 2 clinical study in patients with early Parkinson's disease that is currently ongoing.