On 5 December, ACADIA Pharmaceuticals Inc. presented topline results from its Phase III HARMONY clinical trial of pimavanserin, designed to evaluate the efficacy of pimavanserin. Pimavanserin is an antipsychotic drug that is currently approved for Parkinson’s disease (PD)-related psychosis, under the trade name NUPLAZID. Pimavanserin functions by blocking the 5HT serotonin receptor and is classified as a selective serotonin inverse agonist.
The Phase III HARMONY trial was designed to evaluate the efficacy of pimavanserin in treating dementia-related psychosis, enrolling 392 participants with dementia (vascular, fontotemporal or Alzheimer’s disease dementia, dementia with Lewy bodies or dementia associated with PD) having previously experienced dementia-related psychosis. HARMONY comprised a 12-week open-label pimavanserin treatment period prior to a 26-week long randomisation period. Strong results presented by Erin Foff, Senior Director of Clinical Research at ACADIA Pharmaceuticals Inc., showed that pimavanserin had met its primary endpoint, significantly reducing the risk of relapse of psychosis by 65% during the double-blind, randomisation period. Psychotic symptoms were meaningfully reduced and pimavanserin was well-tolerated by the trial participants, with no worsening in cognition or motor symptoms. ACADIA Pharmaceuticals are now in the process of applying for FDA approval for pimavanserin, with submission anticipated in early 2020. Link to press release: https://ir.acadia-pharm.com/news-releases/news-release-details/acadia-pharmaceuticals-presents-positive-top-line-results?field_nir_news_date_value[min]=
