Acadia Stock Screams Upward; Primary Endpoint Met in Phase II Study of Pimavanserin for Alzheimer’s

Acadia Stock Screams Upward; Primary Endpoint Met in Phase II Study of Pimavanserin for Alzheimer’s December 20, 2016
By Alex Keown, Breaking News Staff

SAN DIEGO – Shares of Acadia Pharmaceuticals are soaring this morning after the company announced its mid-stage drug pimavanserin to treat patients with Alzheimer’s disease psychosis hit its trial endpoints.

In its announcement this morning, Acadia said pimavanserin, a selective serotonin inverse agonist that targets 5-HT2A receptors, showed a statistically significant reduction in psychosis incidents. Pimavanserin was generally well tolerated and the safety profile was consistent with what has been observed in previous studies, the company said. Studies suggest that 25 to 50 percent of patients diagnosed with Alzheimer’s disease may develop psychosis, commonly consisting of hallucinations and delusions, Acadia said.

Pimavanserin has been approved by the U.S. Food and Drug Administration (FDA) for hallucinations and delusions associated with Parkinson’s disease psychosis. It is currently marketed under the brand name Nuplazid.

“Alzheimer’s disease patients suffer from a number of debilitating symptoms, of which psychosis carries a poor prognosis and is associated with earlier placement into nursing homes,” Steve Davis, Acadia’s president and chief executive officer, said in a statement. “Data from the -019 Study provide solid evidence that pimavanserin can improve psychosis in another major neurological disorder and provide strategic momentum for the further development of pimavanserin to address the needs of AD Psychosis patients.”

The news was not all good for Nuplazid’s use in Alzheimer’s disease psychosis. The company did indicate in its announcement that at week 12, the drug did not show any statistical improvement compared to placebo: “On the secondary endpoint of mean change in NPI-NH Psychosis score at week 12, pimavanserin maintained the improvement on psychosis observed at the week 6 primary endpoint, but did not statistically separate from placebo.” As a result of that admission, some industry analysts were skeptical of the drug’s future. Endpoints cited a tweet from Alfredo Fontanini, an associate professor of neurobiology at Stony Brook University School of Medicine, who said that because of the 12 week issue, the trial is largely a failure.

California-based Acadia has been a hot topic of acquisition rumors following the approval of its drug, Nuplazid for the treatment of Parkinson’s psychosis. Nuplazid is used to treat delusions and hallucinations in patients with psychosis caused by Parkinson's disease, a progressive disease that affects the central nervous system and is known for causing tremors. Nuplazid, which targets 5-HT2A receptors, is the only drug that has been approved by the U.S. FDA for this condition. Acadia estimates that approximately 40 percent of the four to six million people worldwide diagnosed with Parkinson’s suffer from Parkinson’s disease psychosis.

The possible use of Nuplazid in Alzheimer’s is attracting the interest of companies like Boston-based Biogen , which has several Alzheimer’s drugs in its pipeline, including aducanumab which targets amyloid plaque in the brain. In addition to its Alzheimer’s treatments, Biogen also has several neurological drugs in its pipeline for Parkinson’s and schizophrenia, which again aligns nicely with what Acadia is doing with Nuplazid. The FDA has not approved any drugs to treat Alzheimer’s disease psychosis.

Although Nuplazid currently comes with a black box warning from the U.S. Food and Drug Administration regarding increased mortality in elderly patients, the drug has the potential to generate $1 billion in revenue.

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