Prothena Presents New Research in the Treatment of Alzheimer’s Disease at Alzheimer’s Association International Conference 2023 (AAIC)

Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, today shared data on three investigational product programs for the treatment and prevention of Alzheimer’s disease, PRX005, PRX012 and PRX123, at the Alzheimer’s Association International Conference 2023 (AAIC) being held July 16-20, 2023 in Amsterdam, Netherlands and virtually.

“Ending Alzheimer’s disease with cutting-edge science is our mission. Our posters at AAIC exemplify our multiple efforts to continue bringing innovation to the Alzheimer’s disease field,” said Wagner Zago, Ph.D., Chief Scientific Officer, Prothena. “From two next-generation antibodies with best-in-class potential, PRX012 and PRX005, to our vaccine, PRX123, our goal is to deliver better outcomes for the millions of patients with this devastating disease and ultimately eradicate it altogether.”

PRX005 Phase 1 Clinical Trial, Single Ascending Dose (SAD) Portion

Poster 74181: PRX005, A Novel Anti-MTBR Tau Humanized Monoclonal Antibody: Results from the Single Ascending Dose Portion of a First-in-Human Double-Blind, Placebo-Controlled, Phase 1 Clinical Trial

The results of the Phase 1 clinical trial SAD portion showed that all three dose level cohorts (low, medium, high) of PRX005 were considered generally safe and well tolerated, meeting the Phase 1 clinical trial SAD portion primary objective and supporting evaluation of doses in the MAD portion of the ongoing Phase 1 clinical trial. PRX005 also met key pharmacokinetic (PK) and immunogenicity secondary endpoints. Plasma drug concentrations of PRX005 increased in a dose-proportional manner. As planned, cerebral spinal fluid (CSF) drug levels were measured in the high dose cohort and reached sufficient CSF concentrations to predict pharmacological targeting of MTBR tau in the central nervous system (CNS) (day 29 CSF:plasma ratio=0.2%).

On July 10, 2023, Prothena announced that Bristol Myers Squibb exercised its $55 million option under the global neuroscience research and development collaboration to obtain the exclusive worldwide commercial rights for PRX005. Bristol Myers Squibb will be responsible for the development, manufacturing, and commercialization of PRX005. All program updates, including results from ongoing and any future PRX005 clinical studies, will be reported by Bristol Myers Squibb going forward.