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Lundbeck has strengthened its pipeline of pharmaceuticals in clinical development by initiating clinical phase II trials with Lu AA39959.
The decision is based on positive pre-clinical results as well as positive conclusions of the phase I trials in healthy individuals.
Lu AA39959 is first in class with a unique target profile. Pre-clinical studies in animal models have shown antipsychotic-like as well as antidepressant-like effects, and Lu AA39959 is expected to show clear and convincing effects in patients with bipolar disorder (also called manic-depressive illness or manic depression), and is also likely to be associated with attractive safety/tolerability profile and additional features, such as low switch-rate to mania.
The clinical phase II study is placebo-controlled and quetiapine-referenced, using a fixed dose of Lu AA39959 in the treatment of patients with bipolar I or II disorder.
The study will include 180 patients in three arms (15 mg Lu AA39959 twice daily, placebo and quetiapine). The primary outcome measure will be reduction of depressive symptoms as measured by the change from baseline in total MADRS score after 8 weeks.
Lu AA39959 affects recently discovered ion channels expressed in the central nervous system and this is the first time this mechanism of action is investigated in patients with bipolar disorder.
“Lu AA39959 appears well tolerated in phase I studies and represents a complete novel approach to the treatment of bipolar disorder. The preclinical profile of Lu AA39959 suggests that the compound, in addition to its anti-depressant-like effect, also possesses the ability to treat manic as well as psychotic symptoms”, says Executive Vice President Anders Gersel Pedersen, Head of Drug Development at Lundbeck.
“We are very pleased with this further strengthening of Lundbeck’s development pipeline.”