BRANFORD, Conn., Dec. 20 /PRNewswire-FirstCall/ -- Neurogen Corporation today announced that it has commenced a Phase II clinical trial in chronic insomnia patients with the Company's insomnia agent, NG2-73. The study will measure sleep maintenance, as well as onset, across a range of doses and formulations. This is one of two ongoing studies designed to measure sleep onset and maintenance in patients with chronic insomnia and this study complements the earlier Phase II clinical trial the Company announced on October 30, 2006.
The Phase II clinical trial announced today is a randomized, double-blind, placebo-controlled, multi-center, cross-over study designed to determine the efficacy and safety of eight different dose and formulation profiles of NG2-73 compared to placebo. The primary endpoint will be wake after sleep onset (WASO). In addition, sleep onset, as measured by latency to persistent sleep (LPS) and additional measures of sleep maintenance will be explored in several secondary endpoints. At least 36 patients with chronic insomnia, aged up to 64 years, are expected to participate in the study. Each patient will be randomly assigned to a treatment sequence of study drug and placebo. Polysomnography will be used to objectively measure various sleep parameters.
The study will test doses and sustained release formulations of NG2-73, which are expected to span the projected therapeutic range. The exposure/response relationships will also be examined and pharmacokinetic/pharmacodynamic (PK/PD) modeling will be utilized to facilitate dose and formulation optimization.
William H. Koster, President and CEO, said, "Our target product profile for NG2-73 is a drug that provides rapid sleep onset and reduces wake time through the night, with patients awakening feeling refreshed and with no hangover effects. We saw dramatic results for rapid sleep onset in our Phase II transient insomnia study. In these concurrent Phase II studies, we are now testing our drug in chronic insomnia patients with sleep initiation and sleep maintenance issues, since people with insomnia may suffer from both. The clinical trial announced in October is a parallel design study and is larger, with sleep onset as its primary endpoint. In this second study, which is a cross-over design, we are primarily assessing sleep maintenance effects for NG2-73."
About Neurogen's Insomnia Program
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 multi-center, 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 subject withdrawals.
Many prescription drugs approved for treatment of both onset and maintenance symptoms of insomnia work by modulating the gamma-aminobutyric acid (GABA) 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, preferentially modulating alpha-3 receptor subtypes of the GABA-A neurotransmitter system.
Helpful websites for information on insomnia: National Sleep Foundation http://www.sleepfoundation.org National Institutes of Health http://www.nih.gov About Neurogen Corporation
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, Parkinson's disease and restless legs syndrome (RLS), pain, depression, and obesity. Neurogen conducts its research and development independently and, when advantageous, collaborates with world-class pharmaceutical companies to access additional resources and expertise.
Safe Harbor Statement
The information in this press release contains certain forward-looking statements, made pursuant to applicable securities laws, that involve risks and uncertainties as detailed from time to time in Neurogen's SEC filings, including its most recent 10-K. Such forward-looking statements relate to events or developments that we expect or anticipate will occur in the future and include, but are not limited to, statements that are not historical facts relating to the timing and occurrence of anticipated clinical trials, and potential collaborations or extensions of existing collaborations. Actual results may differ materially from such forward-looking statements 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, the Company's ability to retain key employees, sufficiency of cash to fund the Company's planned operations and patent, product liability and third party reimbursement risks associated with the pharmaceutical industry. For such statements, Neurogen claims the protection of applicable laws. 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 disclaims any intent and does not assume any obligation to update these forward-looking statements, other than as may be required under applicable law.
Neurogen CorporationCONTACT: Elaine Grimsell Dodge of Neurogen Corp., +1-203-315-4615,edodge@nrgn.com
