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Prothena Corporation (NASDAQ:PRTA) announced Tuesday that PRX005, an Alzheimer's candidate it develops with Bristol Myers Squibb (NYSE:BMY), was found to be safe and well tolerated in a Phase 1 trial, meeting the primary objective of the study.
In this first-in-human trial for the anti-tau antibody, the Phase 1 single ascending dose (SAD) study involved 19 healthy volunteers who received three PRX005 dose levels or placebo intravenously (IV) with a follow-up of up to two months.
The company said that the topline data indicated the study met the primary objective as PRX005 was generally safe and well tolerated across all three cohorts. None of the treatment-emergent adverse events were serious, and the rise of plasma drug concentrations was dose proportional.
Prothena (PRTA) expects to present the findings at a future medical meeting. The ongoing multiple ascending dose (MAD) portion of the study, which involves healthy individuals as well as Alzheimer's patients, is expected to generate topline data by the year-end.
Read: Seeking Alpha contributor Edmund Ingham points out that Prothena's (PRTA) three Alzheimer's programs "likely account for >50% of the company's current market cap valuation."