- Prothena Corporation plc PRTA announced topline data from the Phase 1 single ascending dose (SAD) study for PRX005 for Alzheimer's disease.
- PRX005 is one of three global neuroscience research and development programs in collaboration between Prothena and Bristol Myers Squibb & Co BMY.
- Study participants received a single dose of PRX0005 or placebo intravenously (IV) and were followed for up to two months. The data exhibited that all three dose-level cohorts of PRX005 were generally safe and well tolerated.
- None of the treatment-emergent adverse events (TEAE) were serious. No clinically relevant changes were observed in other safety parameters.
- PRX005 also met key pharmacokinetic (PK) and immunogenicity secondary endpoints. Plasma drug concentrations of PRX005 increased in a dose-proportional manner.
- Furthermore, PRX005 exposure in cerebrospinal fluid (CSF) was measured in the high-dose cohort and based on the robust exposure of PRX005 in the CSF.
- PRX005 had a desirable immunogenicity profile with no persistent PRX005-induced antidrug antibodies observed.
- Topline results from the Phase 1 MAD trial are expected by year-end 2023.
- Price Action: PRTA shares are down 3.55% at $54.64 on the last check Wednesday.
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