Acadia, an actively traded mid-cap biotech, said Monday that it will stop the Phase 3 HARMONY study early based on the recommendation of the independent data monitoring committee that reviewed data from the planned interim analysis.
The HARMONY study is evaluating pimavanserin for the treatment of dementia-related psychosis.
Interim analysis of data showed the study met its primary endpoint by demonstrating a highly statistically significant longer time to the relapse of psychosis with pimavanserin compared to placebo.
The study has a pre-specified stopping criterion of a one-sided p-value less than 0.0033 on the study's primary endpoint.
Pimavanserin has already been approved by the FDA for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis and is marketed under the trade name Nuplazid.
Why It's Important
About 1.2 million patients in the U.S. are diagnosed with dementia-related psychosis, the company said.
No FDA-approved therapies exist for dementia-related psychosis.
"Psychosis adds dramatically to the marked burden that dementia patients already carry and is one of the most challenging-to-manage aspects of the disease for caregivers," said Jeffrey Cummings, the director emeritus of the Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas.
The early halt to the trial is also expected to save resources for the company in terms of both time and money.
Acadia said it is looking ahead to speaking with the FDA about a supplemental new drug application, or sNDA, to support pimavanserin for the treatment of dementia-related psychosis.
At last check, Acadia shares were rallying by 63.32% to $38.87 at the time of publication Monday.
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