Prothena Decides To Discontinue Development Of NEOD001 For AL Amyloidosis

(RTTNews) - Prothena Corporation plc (PRTA) said that it is discontinuing development of NEOD001, an investigational antibody that was being evaluated for the treatment of AL amyloidosis. The decision was based on results from the Phase 2b PRONTO study and a futility analysis of the Phase 3 VITAL study.

Based on the results from the Phase 2b PRONTO study, which did not meet its primary or secondary endpoints, the Company asked the independent data monitoring committee (DMC) of the Phase 3 VITAL study to review a futility analysis of the ongoing VITAL study. The DMC recommended discontinuation of the VITAL study for futility.

The company therefore decided to discontinue all development of NEOD001, including the VITAL study as well as the open label extension studies.

The VITAL Amyloidosis Study was a Phase 3 global, multi-center, randomized, double-blind, placebo-controlled clinical study of NEOD001 vs. placebo in treatment-naïve patients with AL amyloidosis and cardiac dysfunction, with both arms of the study receiving standard of care. The composite primary endpoint was event-based, with all-cause mortality or cardiac hospitalizations as events.