The phase I clinical trial is a randomized, double-blind, placebo-controlled evaluation in healthy volunteers of the safety and pharmacokinetics of single rising oral doses of the drug candidate, NG2-73, which selectively modulates receptors of the gamma aminobutyric (GABA) neurotransmitter system.
Pre-clinical studies suggest that the specific GABA receptor profile of NG2-73 may provide the benefit of sleep with a reduction in next day side effects associated with the first generation GABA hypnotic agents.
In animal models, the compound shows reduced activity at brain cell receptors Neurogen believes cause unwelcome side effects such as impaired learning and memory, ataxia (inability to coordinate voluntary muscle movements), and interaction with alcohol.
“We have confidence in the mechanism of NG2-73 which offers the opportunity for differentiation from currently marketed insomnia medications, as well as those currently in development,” commented William Koster, president and CEO. “We believe our approach can achieve an improved side effect profile.”