BRANFORD, Conn., Dec. 14 /PRNewswire-FirstCall/ -- Neurogen Corporation today announced that it has commenced Phase II human 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. NG2-73 and related compounds are a part of Neurogen’s wholly-owned insomnia program.
The Phase II 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 (LPS). LPS 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 (PK/PD) 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.
William H. Koster, President and CEO, said, “This Phase II trial is the first of a comprehensive plan that will build on the exciting results we have seen in Phase I testing. In studies completed thus far NG2-73 appears to have a very attractive safety profile and we have observed consistent incidents of sleepiness. A Phase I pharmacokinetic/pharmacodynamic (PK/PD) study measuring multiple parameters related to the degree of sedation has provided guidance for establishing the dose range in our Phase II study. Given the body of clinical literature for insomnia, we’re confident that our clinical plan will provide the most useful data to build our case for NG2-73 in an expanding market.”
Neurogen previously announced results from a first-in-human, single ascending dose study and a multiple ascending dose study for NG2-73. In both Phase I trials, the compound was safe and well-tolerated with no serious adverse events.
About Neurogen’s Insomnia Program
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. These studies with NG2-73 compared to the other GABA hypnotic agents that 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.
Webcast
Neurogen will host a conference call and webcast to discuss this announcement at 10:00 a.m. ET today, December 14, 2005. The webcast will be available in the Investor Relations section of www.neurogen.com and will be archived on the website until December 31, 2006. A replay of the call will be available after 1:00 pm ET today and accessible through the close of business December 24, 2005. To replay the conference call, dial 888-286-8010, or for international callers, 617-801-6888, and use the pass code: 91585454.
About Neurogen
Neurogen Corporation is a drug discovery and development company focusing on small molecule drugs to improve the lives of patients suffering from disorders with significant unmet medical need, including insomnia, pain, depression, obesity, and inflammation. Neurogen has generated a portfolio of compelling new drug candidates through its Accelerated Intelligent Drug Discovery (AIDD(TM)) system, its expertise in cellular functional assays, and its depth in medicinal chemistry. Neurogen conducts its research and development independently and, when advantageous, collaborates with world- class pharmaceutical companies.
Neurogen Safe Harbor Statement
The information in this press release contains certain forward-looking statements that involve risks and uncertainties as detailed from time to time in Neurogen’s SEC filings, including its most recent 10-K. Actual results may differ materially from the statements made as a result of various factors, including, but not limited to, risks associated with the inherent uncertainty of drug research and development, difficulties or delays in development, testing, regulatory approval, production and marketing of any of the Company’s drug candidates, adverse side effects or inadequate therapeutic efficacy or pharmacokinetic properties of the Company’s drug candidates or other properties of drug candidates which could make them unattractive for commercialization, advancement of competitive products, dependence on corporate partners, sufficiency of cash to fund the Company’s planned operations and patent, product liability and third party reimbursement risks associated with the pharmaceutical industry. Future results may also differ from previously reported results. For example, positive results or safety and tolerability in one clinical study provides no assurance that this will be true in future studies.
Neurogen Corporation
CONTACT: Elaine Grimsell Dodge, of Neurogen Corp., +1-203-315-4615,edodge@nrgn.com
Web site: http://www.neurogen.com/
