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Acadia stock surges 65% on positive trial result in dementia psychosis

Acadia stock surges 65% on positive trial result in dementia psychosis – US biotech Acadia Pharmaceuticals (Nasdaq: ACAD) saw its stock jump 65% today on the back of a positive result in its “Harmony” Phase III study of Nuplazid (pimavanserin) for dementia-related psychosis. The company reported that the study met its primary endpoint, demonstrating a “highly” stastically significant difference in time to relapse of psychosis in a planned interim efficacy analysis. No specific data were however revealed, as is normal practice, pending presenation at a scientific conference.

Acadia remains a mid-size holding for the UK’s International Biotechnology Trust (IBT), although this shareholding was reduced in the second quarter, according to Marten & Co’s analaysis of the trust’s 13F filings.

HARMONY was designed to evaluate the efficacy and safety of pimavanserin in the treatment of delusions and hallucinations associated with dementia in a broad population of patients with the most common subtypes including Alzheimer’s disease, dementia with Lewy bodies, Parkinson’s disease dementia, vascular dementia, and frontotemporal dementia spectrum disorders. The study included a 12-week open-label stabilisation period during which patients were treated with pimavanserin after which those who met pre-specified criteria for response were randomised to continue on pimavanserin or be switched to placebo. These patients were then followed for up to 26 weeks or until a relapse of psychosis occurred. The primary endpoint in the study was time to relapse in the double-blind period. Relapse, a significant worsening of dementia-related psychosis after prior stabilisation,  was defined in the study by one or more of the following: hospitalization due to dementia-related psychosis, significant deterioration of dementia-related symptoms on clinical scales, withdrawal from the study due to lack of efficacy, or the use of an off-label antipsychotic medication for the treatment of dementia-related delusions and/or hallucinations. All potential relapses and discontinuations in the double-blind portion of the study were adjudicated by an independent adjudication committee to determine if protocol defined relapse criteria were met.

Acadia intends to discuss a possible submission with the FDA next year, although it is unknown whether a positive result of a single Phase III study will be sufficient for approval (two are normally required). Currently no drug is approved specifically for dementia-related psychosis, although anti-psychotic drugs are often prescribed off-label. Nuplazid is already approved in the US for Parkinson’s Disease psychosis, but dementia-related psychosis is thought to represent a much larger market.

Acadia has been working to expand Nuplazid’s label into a number of other areas. Earlier this year, the company reproted a mixed outcome in the “Enhance” Phase III study of Nuplazid in treatment resistant schizophrenia, which did not achieve statistical significance on the primary endpoint, but showed a consistent trend in improvement of psychotic symptoms. The company nevertheless believes that a filing is possible in this incidation in 2020. Acadia is also testing Nuplazid in two Phase III studies as an adjunctive treatment in patients with major depressive disorder (MDD) who have an inadequate response to standard antidepressant therapy.

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