Neurocrine announces phase 1 study of VMAT2 inhibitor, dosing in phase 2 study of MDD drug

Neurocrine Biosciences Inc. announced a phase 1 study to evaluate an investigational neuropsychiatric therapy in healthy adults, as well as commencement of dosing in a phase 2 study of a novel oral compound for major depressive disorder.

According to a company release, the phase 1 trial will examine safety, tolerability, pharmacokinetics and pharmacodynamics of NBI-1065890, an oral, selective inhibitor of the vesicular monoamine transporter-2.

“We're excited to bring this next generation, internally discovered, highly potent, oral, selective VMAT2 inhibitor into the clinic with the hope of providing differentiated benefit in treating certain neurological and neuropsychiatric conditions,” Eiry W. Roberts, MD, chief medical officer at Neurocrine Biosciences, said in the release.

In a separate release, Neurocrine announced that the first patient has been randomized in a phase 2 study to evaluate safety, efficacy and tolerability of the investigational therapeutic NBI-1070770, in adults with MDD.

NBI-1070770 is a novel, selective and orally active negative allosteric modulator of the NR2B subunit-containing N-methyl-D-aspartate receptor.

The phase 2, multicenter, randomized, double-blind, placebo-controlled trial is expected to enroll approximately 72 adults at centers throughout the United States. The study will evaluate safety and efficacy of NBI-1070770 compared with placebo, measuring improvement in depression symptoms by the Montgomery-Åsberg Depression Rating Scale.

“Based upon our phase 1 first-in-human study, we are excited to bring this novel oral compound, which acts through a clinically validated mechanism of action, into clinical development as a potential treatment for major depressive disorder,” Roberts said.