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Prothena Reports Topline Phase 1 Single Ascending Dose Study Results of PRX005, a Novel Anti-MTBR-Tau Antibody for the Potential Treatment of Alzheimer’s Disease
Results from a single ascending dose (SAD) study in healthy volunteers demonstrated dose-proportional PRX005 concentrations in plasma with robust central
About this update from Prothena Corporation Plc
[{"type":"text","content":"\n\nResults from a single ascending dose (SAD) study in healthy volunteers demonstrated dose-proportional PRX005 concentrations in plasma with robust central nervous system (CNS) penetration of this potentially best-in-class investigational anti-MTBR-tau antibody\n\n\nSingle doses of PRX005 across three dose cohorts were generally safe and well tolerated, meeting the primary objective of the study\n\n\nThe Phase 1 multiple ascending dose (MAD) portion of the study is ongoing in healthy volunteers and patients with Alzheimer’s disease; topline results are expected by year end 2023\n\n\n DUBLIN--(BUSINESS WIRE)--\nProthena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, today announced positive topline Phase 1 single ascending dose (SAD) study results for PRX005, a potentially best-in-class investigational tri-epitopic antibody for the treatment of Alzheimer’s disease that specifically binds with high affinity to the R1, R2, and R3 repeats within the microtubule binding region (MTBR) of tau and targets both 3R and 4R tau isoforms. PRX005 is one of three programs in the global neuroscience research and development collaboration between Prothena and Bristol Myers Squibb.\n\n“For the first time, we have confirmation that PRX005 is safe and well-tolerated in humans and that it crosses the blood-brain barrier with robust central nervous system (CNS) penetration. We developed PRX005 to uniquely target a key region within the MTBR of tau to reduce pathogenic tau uptake into neurons, an attribute that has not been similarly achievable with antibodies targeting other regions of tau. These topline Phase 1 data, together with the mounting scientific evidence suggesting that tau propagation could be mediated by MTBR-tau seeds, underscores the potential of PRX005 in treating Alzheimer’s disease,\" said Gene Kinney, PhD, President and Chief Executive Officer of Prothena. \"Working closely with Bristol Myers Squibb, we are combining our expertise to advance the development of PRX005 as quickly as possible, and we look forward to seeing Phase 1 multiple ascending dose (MAD) results in patients with Alzheimer’s disease later this year.”\n\nIn this first-in-human, randomized, placebo controlled, SAD study, healthy volunteers (...