Acadia’s schizophrenia hopeful fails late-stage study

11 Mar 2024
Phase 3AcquisitionNDAClinical Result
Acadia Pharmaceuticals announced late Monday that its experimental schizophrenia treatment pimavanserin failed in a Phase III trial, sending its stock down about 15% during after-hours trading.
It’s the third miss for the inverse serotonin 5-HT2A receptor agonist in central nervous system disorders as Acadia attempts to expand pimavanserin’s label beyond its approval for Parkinson’s disease psychosis, granted by the FDA in 2016. The agency rejected an application for dementia-related psychosis in 2021, and another for Alzheimer’s disease psychosis in 2022. For more, see ViewPoints: Investors see Acadia’s CRL as clearing event.
In the Phase III ADVANCE-2 trial, pimavanserin did not lead to a statistically significant improvement in negative symptoms of schizophrenia versus placebo, the study’s primary endpoint. Improvement was measured using the NSA-16 scale, which assesses change in 16 different symptoms including blunted affect, poor socialisation, and lack of motivation.​
The 26-week study randomized 454 adults with schizophrenia to receive either 34mg of pimavanserin or placebo.
CEO Steve Davis said that while Acadia will continue to analyse the data with its scientific advisors, “we do not intend to conduct any further clinical trials with pimavanserin.”
Despite Acadia’s schizophrenia setback, patients may not have long to wait before treatments hit the market with a novel mechanism of action – muscarinic receptor modulation.
Earlier this year, FirstWord spoke with Christoph Correll – professor of psychiatry and molecular medicine at Hofstra/Northwell’s Donald and Barbara Zucker School of Medicine and medical director in the department of psychiatry at Zucker Hillside Hospital – who shared excitement over the class’s potential to avoid all five of the key side effects that patients complain about with dopamine D2 therapies. For more, see KOL Views Q&A: Leading psychiatrist sees a muscarinic revolution coming in schizophrenia and beyond.
Two large pharmas announced major acquisitions last year to add muscarinic receptor modulators to their pipeline: Bristol Myers Squibb ponied up $14 billion to buy Karuna in December, roughly two weeks after AbbVie agreed to acquire Cerevel for $8.7 billion.
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