NEUROGEN BEGINS CHRONIC INSOMNIA PHASE II TRIAL

Neurogen has begun a Phase II clinical trial in chronic insomnia patients with the company's insomnia agent, NG2-73. The study will measure reduction in time to onset of persistent sleep and sleep maintenance across a range of doses and formulations during two weeks of treatment. NG2-73 selectively modulates receptors of the gamma-aminobutyric acid neurotransmitter system and is one of several unpartnered compounds in Neurogen's portfolio.

The Phase II clinical trial is a randomized, double-blind, placebo-controlled, multicenter, parallel-group study designed to determine the efficacy and safety of five different dose and formulation profiles of NG2-73 compared with placebo. The primary endpoint will be the time it takes to fall asleep as defined by Latency to Persistent Sleep. Sleep maintenance will be explored in several secondary endpoints. At least 240 chronic insomniacs, ages up to 64 years, are expected to receive study drug or placebo for 14 days. Polysomnography will be used to measure various sleep parameters.

The study will test doses and formulations of NG2-73 that span the therapeutic range. Doses to be tested include sustained-release formulations. The exposure/response relationships will also be examined and pharmacokinetic/pharmacodynamic modeling will be utilized to facilitate dose and formulation optimization.

Neurogen previously announced results from Phase II human testing in transient insomnia for NG2-73. The primary endpoint of the study measured the efficacy of NG2-73 in reducing time to onset of persistent sleep in a well-established clinical model of transient insomnia in healthy adults. In the multicenter, 369-subject study, NG2-73 was shown to significantly reduce time to onset of persistent sleep versus placebo at all doses tested. NG2-73 was well-tolerated at all doses, with no drug-related serious adverse events or drug-related premature subject withdrawals.