Shares of San Diego-based Acadia Pharmaceuticals ($ACAD) surged 28% this morning after the biotech spelled out some of its Phase III data on pimavanserin, its experimental therapy for treating psychosis in Parkinson's patients.
In addition to hitting its primary endpoint--demonstrating highly significant antipsychotic efficacy on a reduced 9-item SAPS-PD scale--pimavanserin also scored well on key secondary endpoints. The drug arm was significantly less likely to suffer from hallucinations and delusions than the placebo arm and was twice as likely to rate as "very much improved" or "much improved."
The report marks the latest step ahead for a big turnaround story. Biovail walked away from its partnership with Acadia three years ago, only to watch the company's shares soar over the past year as its lead program appeared headed for an approval at the FDA. Just last December Acadia cashed in on its swelling share price, raising $86 million. And a number of analysts give Acadia a good shot at an approval.
"The significant and consistent results observed across measures in the Phase III -020 Study are impressive and potentially very encouraging for Parkinson's patients who suffer from the psychosis frequently associated with this disease," said Dr. Jeffrey Cummings. "Importantly, regardless of whether assessments were performed by independent blinded raters, site investigators or caregivers, clear benefits were observed and clinical measures were well aligned. The results of this study suggest that a selective, non-dopaminergic-based therapy has the potential to transform the standard of care by providing an effective, safe and well tolerated treatment for patients suffering from this large unmet medical need."
Acadia CEO Uli Hacksell told FierceBiotech last fall that the company has no plans to partner with another company on the development of pimavanserin, which has also shown evidence of potential benefits for patients with Alzheimer's disease.
- here's the release
- here's the AP story