Acadia Pharmaceuticals Inc. (NASDAQ: ACAD) shares dipped on Wednesday despite the announcement of positive top-line results from its Clarity midstage study in major depressive disorder (MDD).
In the trial, pimavanserin met the overall primary endpoint of the weighted average results of Stage 1 and Stage 2 by significantly reducing 17-item Hamilton Depression Rating Scale (HAMD-17) total score compared to placebo.
Additionally, in Stage 1 patients on pimavanserin demonstrated a highly significant improvement in HAMD-17. Importantly, this group of patients saw a benefit over placebo in the first week of treatment. Stage 2 results did not demonstrate significant separation in this small set of placebo non-responders.
For the key secondary endpoint, pimavanserin demonstrated statistically significant reductions compared to placebo in the Sheehan Disability Scale score.
In terms of adverse events, pimavanserin was generally well-tolerated. Discontinuations due to adverse events were 1.2% for pimavanserin and 3.2% for placebo. One subject in each of the pimavanserin and placebo groups reported serious adverse events.
Serge Stankovic, M.D., MSPH, Acadia’s Executive Vice President, Head of Research & Development, commented:
We are pleased with the robustness of the data from our Phase 2 Clarity trial, which shows significant promise for patients with MDD, including early and sustained antidepressant response over placebo, decreased daytime sleepiness, no meaningful weight gain, and improved sexual function. This is important because most people with MDD do not respond to initial antidepressant therapies and experience significant unwanted side effects. Pimavanserin is a selective serotonin inverse agonist, or SSIA, that shows great potential as an antidepressant. We look forward to engaging with the FDA and initiating a Phase 3 program in the first half of 2019.
Shares of Acadia were last seen down about 7% at $19.59, in a 52-week range of $12.77 to $38.00. The stock has a consensus analyst price target of $30.75.