ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) announced the presentation of data from the Phase II -019 Study of pimavanserin in Alzheimer’s disease psychosis at the 10th Clinical Trials on Alzheimer’s Disease (CTAD) meeting in Boston. The -019 Study data are being presented at the symposium titled, “The Importance of Serotonin in Alzheimer’s Disease Psychosis and the Role of Pimavanserin.”
Pimavanserin met the primary endpoint in the Phase II -019 Study, showing a statistically significant reduction in psychosis versus placebo, as previously reported. Data presented at CTAD showed multiple sensitivity and responder analyses supportive of the primary result and demonstrated substantively greater benefit in those patients with more severe psychosis. Building on these data, ACADIA recently initiated the Phase III HARMONY study of pimavanserin in dementia-related psychosis. Dementia-related psychosis includes psychosis in Alzheimer’s disease, dementia with Lewy bodies, Parkinson’s disease dementia, vascular dementia, and frontotemporal dementia. There is no drug approved by the FDA for dementia-related psychosis. In October 2017, the FDA granted Breakthrough Therapy Designation for pimavanserin for the treatment of dementia-related psychosis.
“In the Phase II -019 Study, pimavanserin significantly reduced psychosis in patients with Alzheimer’s disease without negatively impacting cognition,” said Clive Ballard, MBChB, MRCPsych, Pro-Vice-Chancellor and Executive Dean, University of Exeter Medical School. “Pimavanserin also had a favorable tolerability profile compared to known adverse effects of current antipsychotics. With no approved treatment for dementia-related psychosis, there is a significant unmet need. The results of the study indicate that pimavanserin could be an important new treatment option for this elderly and underserved patient population.”
Key Findings from the Phase II -019 Study Presented at CTAD Symposium
The Phase II -019 Study data are being presented by Clive Ballard in the presentation titled, “Clinical Trial of Pimavanserin in Alzheimer’s Disease Psychosis.” The Phase II -019 Study was a double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of pimavanserin in 181 patients with Alzheimer’s disease psychosis. Top-line results of the study were previously reported in December 2016.
Pimavanserin met the primary endpoint in the study, showing a statistically significant reduction in psychosis versus placebo as measured by the Neuropsychiatric Inventory-Nursing Home (NPI-NH) Psychosis score at week 6 of dosing (delta = 1.84, p=0.0451, effect size [Cohen’s d] = 0.32). The proportion of responders at week 6 that had an NPI-NH Psychosis score improvement of ≥ 30% was 55.2% for pimavanserin-treated patients versus 37.4% for placebo (p=0.0159).
Importantly, in the -019 Study, no detrimental effect was observed on cognition for pimavanserin-treated patients compared to placebo. Atypical antipsychotics have been associated with a statistically significant acceleration of cognitive deterioration in patients with Alzheimer’s disease.
The pimavanserin and placebo groups did not separate statistically on the secondary endpoints of the Alzheimer’s Disease Cooperative Study – Clinical Global Impression of Change (ADCS-CGIC) or the Cohen-Mansfield Agitation Inventory Short Form (CMAI-SF), nor on the exploratory endpoints of the mean change in NPI-NH Psychosis score at week 12 or the Alzheimer’s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL).
Data presented at CTAD from a pre-specified subgroup analysis demonstrated a substantively larger and significant reduction in psychosis in pimavanserin-treated patients with more severe psychosis, further underscoring the effect seen on the primary result. Approximately one-third of patients in the study had more severe psychotic symptoms (NPI-NH Psychosis score ≥12). In this subgroup, pimavanserin demonstrated a statistically significant reduction in psychosis versus placebo on the NPI-NH Psychosis score at week 6 (delta = 4.43, p=0.0114, effect size [Cohen’s d] = 0.73). Additionally, the proportion of responders at week 6 that had an NPI-NH Psychosis score improvement of ≥ 30% was 88.9% for pimavanserin-treated patients versus 43.3% for placebo (p=0.0004).
Larger effects were also observed on the NPI-NH Psychosis score in pimavanserin-treated patients with prior antipsychotic use.
As previously reported, pimavanserin was well tolerated in this frail and elderly population and the safety profile was consistent with what has been observed in previous studies.
Shares of Acadia are currently trading at $36.59, up $1.48 or 4.22%. ACAD has a 1-year high of $41.20 and a 1-year low of $20.90. The stock’s 50-day moving average is $36.66 and its 200-day moving average is $31.92.
On the ratings front, ACAD stock has been the subject of a number of recent research reports. In a report issued on October 10, Jefferies analyst Eun Yang reiterated a Buy rating on ACAD, with a price target of $47, which represents a potential upside of 33% from where the stock is currently trading. Separately, on October 9, J.P. Morgan’s Cory Kasimov assigned a Buy rating to the stock.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Eun Yang and Cory Kasimov have a yearly average return of 6.9% and 3.0% respectively. Yang has a success rate of 48% and is ranked #589 out of 4704 analysts, while Kasimov has a success rate of 38% and is ranked #1560.
Sentiment on the street is mostly bullish on ACAD stock. Out of 7 analysts who cover the stock, 6 suggest a Buy rating and one recommends to Hold the stock. The 12-month average price target assigned to the stock is $52.6, which represents a potential upside of 49% from where the stock is currently trading.
ACADIA engages in the research, development and manufacture of pharmaceutical products. It focuses on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders.