Acadia drug fails schizophrenia trial, setting back company’s expansion plans
Dive Brief:
Acadia Pharmaceuticals doesn’t plan to conduct any further clinical trials on its first drug to reach the market after the failure of a Phase 3 study in schizophrenia.
The San Diego-based company had hoped to expand use of the medicine, sold under the brand name Nuplazid for patients with Parkinson’s disease psychosis. But the Phase 3 trial failed to find a significant effect for the drug in treating negative symptoms of schizophrenia, Acadia said late Monday. The company’s shares tumbled 15% early Tuesday.
In the past, Acadia has also tried to extend approval of the medication to patients who suffer from hallucinations and delusions associated with Alzheimer’s disease. The Food and Drug Administration twice rejected the company’s applications for that use. The drug failed as an adjunctive therapy in schizophrenia in 2019 as well.
Dive Insight:
Though some analysts considered the trial a long shot, it offered the chance to access a significant new market for Nuplazid. About 24 million people suffer from schizophrenia around the world, with as many as 6 in 10 displaying so-called negative symptoms that can affect a patient’s verbal or emotional expression, motivation or interest.
A Phase 2 trial of the medicine had suggested some hope for the treatment in those patients. CEO Steve Davis on Monday said the company will continue to analyze the latest data, but has no plans to start up new research for the drug, known under the generic name pimavanserin.
“Ultimately, this isn’t super surprising,” Stifel analyst Paul Matteis wrote in a note to clients. “While the prior study showed a clinical signal, the effect size was small, secondary endpoints were inconsistent and historically, schizophrenia negative symptoms is very challenging.”
The research setback leaves Acadia focused on a pipeline that holds some significant risk. In June last year, Acadia announced plans to start a Phase 3 trial of a medicine for the rare genetic disease Prader-Willi Syndrome that was rejected by the FDA while under development by a different company.
In addition to Nuplazid, Acadia sells the drug Daybue, which was approved in 2023 to treat Rett syndrome. Even with two products on the market and increasing revenue, the company is still losing money. In 2023, the company reported a net loss of about $61 million, or 37 cents a share, compared with $216 million, or $1.34 a share, in the previous year. Last year’s net product sales reached just over $726 million.
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