Exhibit 99.1
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ACADIA Pharmaceuticals Announces PositiveTop-line Results from Phase 2 CLARITY Trial of Pimavanserin for Adjunctive Treatment in Patients with Major Depressive Disorder (MDD)
- Pimavanserin met primary endpoint with statistically significant overall improvement inHAMD-17 total score compared to placebo (p=0.039)
- Pimavanserin met key secondary endpoint with statistically significant overall improvement in Sheehan Disability Scale compared to placebo (p=0.004)
- Positive results also observed on seven additional secondary endpoints including responder rate, improvement in sexual function, and reduction in daytime sleepiness
- ACADIA to initiate Phase 3 program in adjunctive MDD in 1H 2019
- Conference call and webcast to be held today at 8:30 a.m. Eastern Time
SAN DIEGO, CA,October 31, 2018 – ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) today announced positivetop-line results from CLARITY, a randomized, double-blind, placebo-controlled, multi-center, sequential parallel comparison design (SPCD) study in major depressive disorder (MDD). In the study, 207 adult patients with a confirmed inadequate response to existing first-line SSRI or SNRI therapy for MDD received adjunctive treatment of either 34 mg pimavanserin or placebo in addition topre-existing first-line therapy for five weeks (Stage 1). Those patients who did not show a response to placebo in Stage 1 werere-randomized to receive either pimavanserin or placebo for a second five week treatment period (Stage 2).
In the trial, pimavanserin met the overall primary endpoint of the weighted average results of Stage 1 and Stage 2 by significantly reducing17-item Hamilton Depression Rating Scale(HAMD-17) total score compared to placebo (p=0.039). In addition, in Stage 1 (n=207) patients on pimavanserin demonstrated a highly significant improvement inHAMD-17 (p=0.0003). Importantly, this group of patients saw a benefit over placebo in the first week of treatment (p=0.0365). Stage 2 (n=58) results did not demonstrate significant separation in this small set of placebonon-responders.
On the key secondary endpoint, pimavanserin demonstrated statistically significant reductions compared to placebo in the Sheehan Disability Scale (SDS) score (p=0.004).
Positive results were also observed for seven of the eleven other secondary endpoints listed below with nominalp-values: Clinical Global Impression-Severity (p=0.0084), Clinical Global Impression-Improvement (p=0.0289), ShortForm-12 Mental Component Summary (p<0.0001), Karolinska Sleepiness Scale (p=0.0205), Massachusetts General Hospital Sexual Functioning Index (p=0.0003), Barratt Impulsiveness Scale (p=0.0075), as well as response rates (p=0.0065), defined as a 50% or greater reduction on theHAMD-17 total score.