Shares of Acadia Pharmaceuticals Inc. (ACAD) surged nearly 150 percent in morning trade on Tuesday, after its investigational drug pimavanserin met the primary endpoint in a Phase 3 trial in patients with Parkinson's disease psychosis.
In the pivotal late-stage trial, pimavanserin showed significant antipsychotic efficacy and maintenance of motor control in Parkinson's patients.
Pimavanserin also showed major improvements in nighttime sleep, daytime wakefulness and caregiver burden, and was safe and well tolerated.
The late-stage trial enrolled 199 patients, randomized on a one-to-one basis to receive either 40 mg of pimavanserin or placebo once-daily for six weeks. Patients also received stable doses of their existing therapy throughout. The focus of the trial included concerns such as hallucinations and delusions.
Pimavanserin is Acadia's proprietary small molecule that acts selectively as an antagonist/inverse agonist on serotonin 5-HT2A receptors. Earlier, a late-stage trial of the drug failed to show statistical significance owing to robust improvements among the placebo group.
Parkinson's disease psychosis, or PDP, is a debilitating disorder that develops in up to 60 percent of patients with Parkinson's disease. Currently, there is no FDA-approved therapy to treat PDP in the U.S. PDP, commonly consisting of visual hallucinations and delusions, substantially contributes to the burden of Parkinson's disease. According to the National Parkinson's Foundation, about one million people in the U.S. and from four to six million people worldwide suffer from Parkinson's disease.
Acadia is also evaluating pimavanserin in mid-stage trials for patients with schizophrenia and Alzheimer's disease psychosis.
Acadia stock is trading at $5.56, up $3.38 or 147%, on a volume of about 31 million shares on the Nasdaq.
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