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Biotech / Medical : Neurogen (NRGN) -- Ignore unavailable to you. Want to Upgrade?

To: Jim Oravetz who wrote (421)	9/22/2005 12:15:39 PM
From: tuck	Respond to of 523

NRGN announces results of P1 for insomnia drug: >>BRANFORD, Conn., Sept. 22 /PRNewswire-FirstCall/ -- Neurogen Corporation (Nasdaq: NRGN - News) today announced that it has completed the first-in-human, single ascending dose study of the Company's leading drug candidate for insomnia, NG2-73, which selectively modulates receptors of the gamma- aminobutyric acid (GABA) neurotransmitter system. In this Phase I trial, the compound was safe and well-tolerated across a broad dose range. Consistent with the expected action of the drug, study investigators also observed reports of sleepiness among treated subjects. The study objectives were to evaluate the safety, tolerability, and pharmacokinetics of escalating single oral doses of NG2-73 in healthy male and female subjects. The study was a randomized, double-blind, placebo-controlled evaluation conducted in a single U.S. center, including 48 subjects in eight cohorts. In this escalating dose study, each cohort of subjects received a higher dose of the drug than the preceding cohort with the objective of exploring a wide range of doses to define a maximum tolerated dose. The dose limiting effect of the drug in this study was a deep sleep. NG2-73 demonstrated a dose proportional increase in concentration in subjects' blood samples with each cohort. William H. Koster, President and CEO, said, "We're very pleased with the solid results of our single rising dose study. Though not an endpoint of the trial, an apparent effect of the drug was that NG2-73 induced sleep in treated subjects, consistent with the results of our preclinical animal studies. The pharmacokinetics of NG2-73, coupled with the physical/chemical characteristics of the compound, provide the potential to achieve fast onset of sleep and we are currently developing alternate formulations designed to provide optimal sleep maintenance." The prescription drugs dominating the insomnia market work by modulating the GABA-A system of neurotransmitters. GABA is a chemical naturally released in certain parts of the brain in order to inhibit brain activity. Preclinical studies suggest that NG2-73 is pharmacologically distinct from currently marketed insomnia agents, as well as those in development. The GABA-A receptor profile for NG2-73 is distinguished from other GABA receptor hypnotics by its preferential activity at the alpha-3 receptor subtype, relative to other receptor subtypes, at expected therapeutically relevant concentrations. Preclinical animal studies with NG2-73 compared to the other GABA hypnotic agents, which are potent agonists at multiple receptor subtypes, indicate that NG2-73 may provide the benefit of sleep with a reduction in next day side effects. Dr. Koster continued, "We are moving forward with our Phase I program and, in a second study, we're currently testing multiple ascending doses of NG2-73 in healthy subjects. In addition, a PK/PD (pharmacokinetic/pharmacodynamic) study is underway to evaluate the sleep-inducing effects of the drug at various dosages in order to establish a range of doses for Phase II studies. We will also evaluate data from these on-going studies to further profile the pharmacokinetic properties of the drug. We believe NG2-73 offers the opportunity for a compelling sleep agent in a market with unmet medical need, which continues to grow." Webcast Neurogen will host a conference call and webcast to discuss today's announcement at 10:00 a.m. ET today, September 22, 2005. The webcast will be available in the Investor Relations section of http;//www.neurogen.com and will be archived on the website until December 31, 2005. A replay of the call will be available after 1:00 pm ET today and accessible through the close of business October 6, 2005. To replay the conference call, dial 888-286-8010, or for international callers, 617-801-6888, and use the pass code: 17109770.<< snip Cheers, Tuck