BRANFORD, Conn., Oct. 30 /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 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 (GABA) 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, multi-center, parallel group study designed to determine the efficacy and safety of five different dose and formulation profiles of NG2-73 compared to placebo. The primary endpoint will be the time it takes to fall asleep as defined by Latency to Persistent Sleep (LPS). Sleep maintenance will be explored in several secondary endpoints. At least 240 chronic insomniacs, aged 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 which are expected to span the therapeutic range. Doses to be tested include sustained release formulations. 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, “We are building on the positive and highly significant results of our Phase II transient insomnia study, where NG2-73 demonstrated dramatic improvement over placebo for LPS. We now will seek to confirm the robust LPS response in chronic insomniacs and begin to assess sleep maintenance, since insomniacs may suffer from sleep initiation, sleep maintenance issues or both.
“Our target product profile for NG2-73 is a drug that provides quick onset and reduces wake time through the night, with patients awakening feeling refreshed and with no hangover effects. In order to expand and intensify our knowledge of doses and formulations of NG2-73 for duration of action, we plan to launch an additional concurrent study in insomniacs later this year.”
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 premature subject withdrawals.
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 11:00 a.m. ET today, October 30, 2006. 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, 2006. A replay of the call will be available after 1:00 pm ET today and accessible through the close of business November 20, 2006. To replay the conference call, dial 888-286-8010, or for international callers, 617-801-6888, and use the pass code: 43091770.
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, pain, depression, and obesity. 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.
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 Corporation
CONTACT: Elaine Grimsell Dodge, Neurogen Corp., +1-203-315-4615,edodge@nrgn.com
Web site: http://www.neurogen.com/
