Acadia Scraps a Phase II Alzheimer's Trial, Gets Breakthrough Tag for Dementia-Related Drug

Published: Oct 06, 2017

Acadia Scraps a Phase II Alzheimer's Trial, Gets Breakthrough Tag for Dementia-Related Drug October 5, 2017
By Alex Keown, BioSpace.com Breaking News Staff

SAN DIEGO – After posting mixed results for its pimavanserin trial in December, Acadia Pharmaceuticals is broadening its research focus from Alzheimer’s disease psychosis to the treatment of hallucinations and delusions associated with dementia-related psychosis.

The California-based company is taking its drug Nuplazid (pimavanserin) into Phase III trials for dementia-related psychosis. The plan was bolstered by the U.S. Food and Drug Administration’s granting of the Breakthrough Therapy Designation to Nuplazid for the treatment. Dementia-related psychosis includes psychosis in patients with Alzheimer’s disease, dementia with Lewy bodies, Parkinson’s disease dementia, vascular dementia and frontotemporal dementia.

Nuplazid, a selective serotonin inverse agonist that targets 5-HT2A receptors, has been approved by the U.S. Food and Drug Administration for hallucinations and delusions associated with Parkinson’s disease psychosis. In its announcement this morning, Acadia said if the new indication for Nuplazid is approved by the FDA, it would be the first therapy approved for this condition.

Acadia R&D head Serge Stankovic said diving into the Phase III trial for dementia-related psychosis is supported by “clinical and preclinical evidence of pimavanserin’s antipsychotic activity without detrimental effects on cognitive function or other side effects associated with antipsychotics currently used off-label for this indication.”

Steve Davis, president and chief executive officer of Acadia, said Nuplazid has a unique biological mechanism that distinguishes it from any other antipsychotic. Following the Phase II study of Alzheimer’s disease, Davis said company researchers believed Nuplazid could be “particularly beneficial” in the underserved population of dementia patients with psychosis. In the Phase II Alzheimer’s study, Nuplazid showed a statistically significant reduction in psychosis incidents at week six of the study. However, after week 12, the drug did not statistically differentiate itself from placebo.

Davis pointed to the drug’s Phase II benefit as an antipsychotic without impairment of cognition.

“We were very excited to be the first and only FDA approved drug for the treatment of Parkinson’s disease psychosis and are equally excited about the potential to help many more patients suffering from dementia-related psychosis,” Davis said.

If the Phase III proves successful, Acadia believes the results, coupled with supporting data from previous Nuplazid studies, could lead to regulatory approval from the FDA.

The news certainly sparked the interest of investors. Shares prices rose from Wednesday’s close of $39.08 to $40.73 this morning.

Leerink analyst Paul Matteis said the Breakthrough Therapy Designation for Nuplazid is encouraging, Endpoints News reported.

“Moreover, if the study succeeds, the addressable population could be very large, rendering how we currently model the ADP revenue oppty conservative. However, ACAD’s “basket” approach to this new ph3 may introduce additional challenges that are simply difficult to handicap: while the trial works to enrich the placebo-controlled portion for pimavanserin responders, we see the inclusion of such a heterogeneous population in a single pivotal as a risky strategy,” Matteis said in his note, according to Endpoints.

There are approximately 8 million people in the United States with a form of dementia and about half of those have been diagnosed. Acadia said about 30 percent of dementia patients have psychosis, which typically consists of hallucinations or delusions.

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