ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders, announced that Jeffrey Cummings, M.D., Sc.D., Director of Cleveland Clinic Lou Ruvo Center for Brain Health, presented detailed results today from ACADIA’s pivotal Phase III -020 Study with pimavanserin in patients with Parkinson’s disease psychosis at the Emerging Science session of the 65
American Academy of Neurology (AAN) Annual Meeting. The analysis of the full data set from the Phase III -020 Study showed robust and consistent efficacy of pimavanserin across a wide array of study measures and confirmed the positive top-line results previously reported.
Pimavanserin met the primary endpoint in the -020 Study by demonstrating highly significant antipsychotic efficacy on the 9-item SAPS-PD scale (p=0.001). Pimavanserin also met the key secondary endpoint for motoric tolerability as measured using Parts II and III of the Unified Parkinson’s Disease Rating Scale, or UPDRS. Dr. Cummings presented new data from the -020 Study showing highly significant improvements in all secondary efficacy measures, including the Clinical Global Impression Severity, or CGI-S, scale (p<0.001), the Clinical Global Impression Improvement, or CGI-I, scale (p=0.001), and a CGI-I responder analyses (p=0.002). The CGI-I responder results showed that approximately twice as many subjects in the pimavanserin treatment arm, as compared to placebo, were rated as very much improved or much improved at the conclusion of the study. In addition, pimavanserin demonstrated significant improvements using the full 20-item SAPS scale and each of the separate hallucinations and delusions domains in supportive analyses. Statistically significant benefits were also observed in exploratory measures of nighttime sleep, daytime wakefulness, and caregiver burden.
“The significant and consistent results observed across measures in the Phase III -020 Study are impressive and potentially very encouraging for Parkinson’s patients who suffer from the psychosis frequently associated with this disease,” said Dr. Jeffrey Cummings. “Importantly, regardless of whether assessments were performed by independent blinded raters, site investigators or caregivers, clear benefits were observed and clinical measures were well aligned. The results of this study suggest that a selective, non-dopaminergic-based therapy has the potential to transform the standard of care by providing an effective, safe and well tolerated treatment for patients suffering from this large unmet medical need.”