Up another 65% today after stating that the PhIII study (top line results reported last November) is sufficient for filing an NDA.
ACADIA Announces Presentation of Data from Its Pivotal Phase III Parkinson's Disease Psychosis Study with Pimavanserin at the American Academy of Neurology Annual Meeting
22:00 EDT Wednesday, March 20, 2013
SAN DIEGO (Business Wire) -- 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 65th 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.”
Safety and Tolerability Profile
Consistent with previous studies, pimavanserin was safe and well tolerated in the -020 Study. The most common adverse events were urinary tract infection (11.7% PBO vs. 13.5% PIM) and falls (8.5% PBO vs. 10.6% PIM). Adverse events were generally characterized as mild to moderate in nature. The only serious adverse events that occurred in more than one patient were urinary tract infection (1-PBO vs. 3-PIM) and psychotic disorder (0-PBO vs. 2-PIM). Over ninety percent of the patients who completed the clinical phase of this trial elected to roll over into the ongoing open-label safety extension study. Patients were only eligible to participate in the extension study if the treating investigator also deemed them to be likely to benefit from continued treatment with pimavanserin.
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