Prothena Corporation plc (NASDAQ: PRTA)announced that the Company 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.
"We are deeply disappointed by this outcome, particularly for patients suffering from this devastating disease," said Gene Kinney, PhD, President and Chief Executive Officer of Prothena. "We are surprised by the results from these two placebo-controlled studies and will continue to analyze the resulting data to share insights with our collaborators in the scientific, medical and advocacy communities. We thank all of the patients, their families, caregivers, investigators, study staff and our employees. Their participation in and commitment to these studies are indispensable to advancing our shared goal of improving the lives of patients with amyloidosis."
"Prothena has a deep pipeline of novel therapeutics in clinical and preclinical development, including several partnered with leading strategic collaborators," stated Lars Ekman, MD, PhD, Chairman of Prothena's Board of Directors. "We have the resources and scientific expertise to continue to advance our pipeline through meaningful development milestones towards our goal of transforming patients' lives."