ACADIA Pharmaceutical Inc. (NASDAQ:ACAD) announced that following a positive response from the FDA; the company is planning to combine its CLARITY-2 and CLARITY-3 third phase studies. This is for the evaluation of pimavanserin for adjunctive major depressive disorder treatment into a single study having a pre-defined statistical analysis plan.
Data from the CLARITY studies to support new drug application for pimavanserin
Following the studies’ combination, the company will not enroll new patients in the two matching third phase studies. However, each of the studies will be finalized with at least over 50% enrolment. ACADIA is anticipating reporting of top-line data from the combined studies in the Q3 of 2020. If the company reports positive data from these combined studies and the positive results from the previous pivotal CLARITY, trial will help form a basis for supplemental novel drug application for the company’s pimavanserin in adjunctive MDD treatment.
Both CLARITY-2 and CLARITY 3 are 6-week randomized, multi-center, double-blind, parallel designed studies evaluating the safety and efficacy of pimavanserin as an adjunctive MMD treatment in patients with inadequate response to the conventional antidepressant therapy of either serotonin-norepinephrine reuptake inhibitor or selective serotonin reuptake inhibitor. In both studies, patients were randomized and received 34mg of pimavanserin in oral treatment and placebo once per day, supplementing their antidepressant treatments. The primary endpoint of the studies is the baseline change on the 17-item Hamilton Depression Rating Scale total score.
The patients that completed the third phase studies are eligible o take part in the current 52-week open-label extension trial evaluating the long-term tolerability and safety of pimavanserin in the treatment of MMD.
CLARITY study conducted across 27 centers in the US
On the other hand, the CLARITY study, which was a second phase trial, was a 10-week double-blind, randomized multi-center placebo-controlled 2-stage sequential parallel comparison design study that evaluated the tolerability, efficacy, and safety of pimavanserin in treatment of MDD. The company conducted the study in partnership with Massachusetts General Hospital Clinical Trials Network & Institute, randomizing 207 subjects in 27 centers.