Acadia Pharmaceuticals revealed late-stage clinical data this week that could support bringing its drug for psychosis to a broader group of patients.
The Acadia (NASDAQ: ACAD) drug pimavanserin (Nuplazid) is currently approved for treating psychosis associated with Parkinson’s disease. But the San Diego-based company has also been testing the drug in dementia-related psychosis (DRP), which includes those with Alzheimer’s disease, dementia with Lewy bodies, Parkinson’s disease dementia, vascular dementia, and frontotemporal dementia patients who are experiencing hallucinations and delusions.
At the 12th annual Clinical Trials on Alzheimer’s Disease congress, Acadia presented detailed data from HARMONY, its Phase 3 study of the drug in DRP, which showed a significant benefit for those patients compared to a placebo. Acadia’s stock price jumped 14 percent after the company’s presentation late Wednesday, closing at $50.48 per share Thursday.
Earlier this year Acadia announced it would stop the trial early because the drug had already met its primary goal, significantly the reducing of relapse among patients with DPR. Data revealed Wednesday showed that the drug had done so by about 65 percent. It also met a secondary goal of reducing risk of discontinuation or stopping use of the drug, by 55 percent.
Those results are “as good as we could have hoped for,” wrote SVB Leerink analyst Marc Goodman in a research note.
About 8 million people in the US are living with dementia, and about 30 percent, or 2.4 million people, also have the delusions and hallucinations characteristic of psychosis, according to the company. These symptoms can significantly worsen quality of life for both those suffering from psychosis and their caregivers—and can even be a turning point at which institutionalization becomes necessary. Today some of those patients are treated with antipsychotic drugs, used off-label.
“They all work in pretty similar ways, primarily by blocking dopamine,” Davis said. However, the medications can lead to complications, especially in dementia patients, who tend to be older and frailer. And symptoms of psychosis, which are common, tend to appear later in the disease’s progression.
“[Antipsychotics] can impair motor function, which can lead to falls; they’re highly sedated…they’re really very imperfect drugs for those populations,” Davis said.
Acadia wants its drug—which works in a different way by targeting other receptors believed to play an important role in DRP—to become what clinicians turn to in such cases. If the FDA approves the drug as a treatment for DRP, it would significantly expand the number of patients to whom it could be prescribed.
The company said its drug was well tolerated, with a discontinuation rate of 2.9 percent compared to 3.6 percent for the placebo due to side effects. Two deaths during during the trial were not related to the drug’s use, according to investigators. The most common side effects were headache and urinary tract infection.
Davis said the company anticipates a meeting with the FDA in the first half of 2020, then filing for review “as soon after that as we can.”
In the first nine months of this year Acadia reported earning $240.8 million in revenue from product sales, compared to $164.2 million in the same months of 2018. Over that time the company reported a net loss of $182.2 million, compared to a net loss of $179.7 million in the same time the year prior.
Acadia is also testing the drug as an adjunctive treatment for patients with a type of schizophrenia characterized by a flat affect and other so-called “negative symptoms,” and in major depressive disorder. Earlier this year, however, the drug failed a late-stage trial in another subset of schizophrenia patients who hadn’t responded to a handful of existing antipsychotic drugs.