Rapastinel demonstrates pro-cognitive benefits in animal model of cognitive impairment

Allergan has announced new data on the investigational medication rapastinel (GLYX-13) and its lack of impairment on cognitive function.

The goal of this study was to compare the effects on cognition of rapastinel and ketamine in novel object recognition (NOR) in mice. The NOR task is a validated animal model of human declarative memory (memory of facts and events) that has been widely used to identify differences across compounds. Deficits in learning and memory are often comorbid conditions in patients suffering from a number of mental illnesses including major depressive disorder, bipolar disorder, and schizophrenia.

The study found that unlike ketamine and phencyclidine (PCP), rapastinel did not cause deficits in NOR in mice. This study also demonstrated rapastinel’s ability to reverse NOR deficits produced by a single exposure to ketamine or multiple doses of PCP or ketamine. In addition, rapastinel like ketamine has fast onset antidepressant effects. Allergan says the data from this study demonstrates that rapastinel does not share some of the less desirable pharmacological properties of ketamine.

Rapastinel demonstrated pro-cognitive benefits

Commenting on the data, Herbert Y. Meltzer, MD, Professor of Psychiatry, Northwestern Feinberg School of Medicine, said, “This work demonstrates that rapastinel, unlike ketamine, did not induce transient or persistent cognitive deficits in normal mice. Further, rapastinel, but not ketamine, as administered here, demonstrated pro-cognitive benefits in a well-studied animal model of cognitive impairment. This difference merits further study in patients who are candidates for rapidly acting antidepressant treatment.”

David Nicholson, Executive Vice President and President of Global R&D brands at Allergan, added, “We are encouraged by these promising study findings and what they could mean in clinical practice and plan to begin pivotal phase 3 trials of rapastinel later this year.”

Rapastinel (formerly known as GLYX-13) is an investigational intravenous formulation of a novel NMDA receptor partial agonist, which is being evaluated for adjunctive treatment of Major Depressive Disorder (MDD), and has shown a rapid onset of antidepressant efficacy 1 day after a single dose in a Phase 2 clinical trial of patients with MDD who had an inadequate response to one or more antidepressants. No psychotomimetic or hallucinogenic side effects were observed with rapastinel.