PRTA - Prothena's PRX012 for Alzheimer's gets FDA nod to enter clinical trial

Prothena (NASDAQ:PRTA) said the U.S. Food and Drug Administration cleared an investigational new drug (IND) application for its antibody drug candidate PRX012 to enter trial for treating Alzheimer’s disease (AD). The company said it has begun a phase 1 single ascending dose study to test PRX012 in both healthy volunteers and patients with AD. Prothena expects to start the phase 1 multiple ascending dose study by this year end. The company said preclinical data had shown that the drug binds to Alzheimer's associated protein called beta amyloid plaques and oligomers with high avidity, enabling effective levels of A? plaque occupancy at relatively lower dose ranges. "PRX012’s high binding potency and subcutaneous administration has the potential to serve as a foundational anti-A? treatment for Alzheimer’s disease," said Gene Kinney, Prothena's CEO. Earlier this month, the clinical-stage biotech said it plans to file an IND application for its dual A?/tau vaccine candidate targeted at Alzheimer’s disease in 2023.

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Prothena's PRX012 for Alzheimer’s gets FDA nod to enter clinical trial