ACADIA Pharmaceuticals to Present Phase 2 CLARITY Results for Pimavanserin as an Adjunctive Treatment in Major Depressive Disorder at the 2019 American Psychiatric Association Annual Meeting - Seite 2

In the trial, pimavanserin met the overall primary endpoint of the weighted average results of Stage 1 and Stage 2 by significantly reducing the 17-item Hamilton Depression Rating Scale total score compared to placebo (p=0.039). On the key secondary endpoint, pimavanserin demonstrated statistically significant reductions compared to placebo in the Sheehan Disability Scale score (p=0.004). Positive results were also observed for seven other secondary endpoints, including improvement in daytime sleepiness as measured by the Karolinska Sleepiness Scale and improvement in sexual function as measured by the Massachusetts General Hospital Sexual Functioning Index.

“In this Phase 2 study of pimavanserin as an adjunctive treatment for MDD, we found patients treated with pimavanserin experienced significant reduction in their depression symptoms in addition to improvement in daytime sleepiness and sexual function when compared to placebo,” said Serge Stankovic, M.D., M.S.P.H., ACADIA’s President. “These results are encouraging for patients with MDD who may experience challenges with their current treatment options. We look forward to further evaluating pimavanserin as an adjunctive treatment in our ongoing Phase 3 CLARITY program.”

On April 25, ACADIA announced it had initiated its Phase 3 CLARITY program for pimavanserin as an adjunctive treatment for MDD. The CLARITY-2 study will be based in the U.S. and has already initiated enrollment and the CLARITY-3 study will be based outside the U.S. and will initiate enrollment in the upcoming months. Both studies are six-week, parallel-designed, randomized, double-blind, placebo-controlled, multi-center studies designed to evaluate the efficacy and safety of pimavanserin as adjunctive treatment in patients with MDD who have an inadequate response to standard antidepressant therapy with either a SSRI or a SNRI.

About Major Depressive Disorder
According to the National Institute of Mental Health, MDD affects approximately 16 million adults in the U.S.¹, with approximately 2.5 million adults treated with adjunctive therapy.^2,3 MDD is a condition characterized by depressive symptoms such as a depressed mood or a loss of interest or pleasure in daily activities for more than two weeks, as well as impaired social, occupational, or other important functioning. The majority of people who suffer from MDD do not respond adequately to initial antidepressant therapy.⁴