Neurogen begins phase 2 testing for lead candidate NG2-73 to treat insomnia

By E. Janene Geiss

Philadelphia, Dec. 14 - Neurogen Corp. announced Wednesday that it has started phase 2 testing of the company's leading drug candidate for insomnia, NG2-73, which selectively modulates receptors of the gamma-aminobutyric acid (GABA) neurotransmitter system.

The primary endpoint of the study will measure the efficacy of NG2-73 in reducing time to onset of persistent sleep in a model of transient insomnia in healthy adults, according to a company news release.

NG2-73 and related compounds are a part of Neurogen's wholly owned insomnia program.

The phase 2 clinical trial is a randomized, double-blind, placebo-controlled study, designed to determine the efficacy of four dose levels of NG2-73 compared to placebo in reducing the time it takes to fall to sleep as defined by Latency to Persistent Sleep.

Latency to Persistent Sleep will be measured in a single-night model of transient insomnia where temporary insomnia is induced in normal subjects by environmental stress.

The transient insomnia model has been well established for the clinical development of other sleep agents. The exposure response relationship for NG2-73 will be examined using pharmacokinetic/pharmacodynamic modeling and a routine safety assessment will be made.

The study will be conducted at 12 sites in the United States. Healthy adult subjects will be enrolled in five treatment arms totaling 360 subjects, officials said.

"This phase 2 trial is the first of a comprehensive plan that will build on the exciting results we have seen in phase 1 testing. In studies completed thus far NG2-73 appears to have a very attractive safety profile and we have observed consistent incidents of sleepiness," William H. Koster, president and chief executive officer, said in the release.

In phase 1 ascending-dose study and multiple ascending-dose study, NG2-73 was safe and well-tolerated with no serious adverse events, officials said.

Neurogen is a Branford, Conn., drug development company focusing on small molecule drugs to treat disorders that include insomnia, pain, depression, obesity and inflammation.

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