Citi: ACADIA Pharmaceuticals Inc (ACAD)
Pimavanserin Call with Physician Expert Confirms High Unmet
Need in Parkinson’s Disease Psychosis
? What's New — We hosted a call with a physician expert on the prospects of
Pimavanserin in Parkinson’s Disease Psychosis (PDP). Results from first
pivotal Ph. 3 trial for Pimavanserin expected in this quarter.
? What is PD Psychosis — 1.6M patients have Parkinson’s disease in the U.S.
and approx. 25% will develop psychosis. According to physician expert,
hallucinations and delusions are main manifestations of disease. Symptoms
can be extremely debilitating and key reason for nursing home placement.
Psychosis in PD patients linked to dopamine therapy for movement disorders.
? Current Treatments for PD Psychosis — There are no approved drugs for PDP.
According to physician expert, Seroquel is used today as 1st line treatment for
PDP. However, there is no data to support its use and it’s thought to have only
limited efficacy, if any. 2nd line agent, Clozapine, is highly effective, but has
safety risks which require pts to undergo weekly blood monitoring, severely
limiting it use.
? High Unmet Need — Physician expert confirmed high unmet need in PDP, due
to the seriousness of the condition and shortcomings of current agents.
Physician believes that Pimavanserin will be positioned as first-line agent
almost immediately, if approved.
? Efficacy Bar for Ph 3 Trial — Primary endpoint for Ph.3 trial is antipsychotic
efficacy on SAPS. In Ph. II trial, Pimavanserin improved SAPS score by 4.4 pts
versus placebo. According to Physician expert, a similar improvement in Ph. 3
trial would be clinically important. Physician believes 4 or 5 pts on SAPS would
be recognized by caregivers, a key determinant of efficacy in clinical setting.
? Potential for Off-Label Use — According to physician expert, if approved,
Pimavanserin may see off-label use in Alzheimer’s Disease Psychosis (ADP)
and Dementia with Lewy Bodies (DLB), which have similar disease
mechanisms to PDP. DLB, in particular, can often be indistinguishable from
PDP at certain points in the disease. |
