Shares of Acadia Pharmaceuticals (NASDAQ:ACAD) fell more than 9% Thursday morning after the company reported mixed Phase 2 results for remlifanserin, its experimental treatment for Alzheimer's disease psychosis.
The once-daily 60 mg dose eased hallucinations and delusions more than placebo on the trial's main measure, but the result fell just short of statistical significance at six weeks. The 30 mg dose showed little benefit over placebo.
On a secondary measure of overall symptom severity, the 60 mg dose did significantly outperform placebo. The company said the 60 mg dose kept pulling further ahead of placebo on both measures throughout the six-week study.
Acadia said it will continue enrolling its two ongoing Phase 3 studies of remlifanserin in Alzheimer's disease psychosis, while amending the program to drop the 30 mg dosage arm and move forward with 60 mg only.
The drug's safety profile was a bright spot: rates of adverse events, serious adverse events and discontinuations were similar to placebo, with no signal of QT prolongation and no apparent negative impact on motor symptoms or cognition. There were no deaths in either treatment arm.
Still, analysts at Baird described the update as "incrementally negative," noting that while the 60 mg dose came close to statistical significance with a clean safety profile, investors are likely to be disappointed by the miss.
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