Neurogen Announces Adipiplon Preclinical and Clinical Data to Be Presented at Neuroscience 2007BRANFORD, Conn.--(BUSINESS WIRE)--Nov 6, 2007 - Neurogen Corporation (Nasdaq: NRGN), a drug discovery and development company, today announced that data from several preclinical and clinical studies with adipiplon (formerly NG2-73), the Company's lead compound for the treatment of insomnia, will be presented on November 6 in five posters at Neuroscience 2007, the Society for Neuroscience annual meeting in San Diego, California.
To date adipiplon has been tested in over 600 subjects in eight clinical studies. Results from two Phase 2b studies with adipiplon in chronic primary insomnia patients were announced earlier this year. These data demonstrated doses that met primary endpoints for sleep induction and for sleep maintenance, with statistical and clinical significance, and with no next-day residual effects. In these Phase 2b studies, adipiplon also achieved statistical significance over placebo for improvement in patient-assessed sleep quality. In addition, this critical measure of patient satisfaction was achieved in a Phase 2a study of adipiplon in transient insomnia--a model of insomnia conducted with healthy volunteers.
Adipiplon has a novel profile, different from currently marketed GABA insomnia drugs and from GABA drugs in development for the treatment of insomnia. Adipiplon is a partial GABA agonist with preference for the alpha-3 subtype receptor, which is associated with the reduction of anxiety, as well as hypnotic, or sleep effects. In clinical studies to date, adipiplon has been shown to be safe and well tolerated.
Posters will be displayed at the Neuroscience 2007 meeting at the San Diego Convention Center in Exhibit Halls B-H in the "Sleep: Systems and Behavior" session on Tuesday, November 6, from 8:00 a.m. - noon PT. -0-
Tuesday, November 6, 2007 "I. Preclinical characterization in vitro of NG2-73 as a potent and selective partial allosteric activator at the benzodiazepine site of GABA(A) receptors with predominant efficacy at the (alpha)3 subunit" (Abstract control number: 112013) Poster Board Number: AAA26, 10:00-11:00 a.m. PT "II. Preclinical characterization in vivo of NG2-73, an (alpha)3- subunit preferring GABA(A) receptor partial allosteric activator, as a sedative-hypnotic agent with an improved side effect profile relative to zolpidem" (Abstract control number: 111951) Poster Board Number: AAA23, 11:00 a.m.-12:00 p.m. PT "III. Clinical trial data demonstrating sedative-hypnotic efficacy of the (alpha)3-subunit preferring GABA(A) receptor partial allosteric activator, NG2-73: Translational validity of pharmacokinetic/pharmacodynamic (PK/PD) relationships derived from preclinical studies" (Abstract control number: 111673) Poster Board Number: AAA17, 9:00-10:00 a.m. PT "IV. Further pharmacological exploration of (alpha)3-subunit preferring GABA(A) receptor partial allosteric activators: Evidence for anxiolysis and reduced sedative tolerance of NDT 9530021" (Abstract control number: 112734) Poster Board Number: AAA21, 9:00-10:00 a.m. PT "V. Further pharmacological exploration of (alpha)3-subunit preferring benzodiazepine site partial allosteric activator sedative-hypnotics: Anticonvulsant activity of NDT 9530021 in rats" (Abstract control number: 107530) Poster Board Number: AAA24, 8:00-9:00 a.m. PT
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, obesity, pain, Parkinson's disease, restless legs syndrome (RLS), and depression. Neurogen conducts its research and development independently and, when advantageous, collaborates with world-class pharmaceutical companies to access additional resources and expertise.
Neurogen Safe Harbor Statement
The information in this press release contains certain forward-looking statements, made pursuant to applicable securities laws, which 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 activities, events or developments that Neurogen believes, expects or anticipates will occur in the future and include, but are not limited to, earnings estimates, statements that are not historical facts relating to Neurogen's future financial performance, its growth and business expansion, its financing plans, the timing and occurrence of anticipated clinical trials, and potential collaborations or extensions of existing collaborations. These statements are based on certain assumptions made by Neurogen based on its experience and perception of historical trends, current conditions, expected future developments and other factors it believes are appropriate under the circumstances. Actual results may differ materially from those expressed or implied by 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 Neurogen's drug candidates, adverse side effects or inadequate therapeutic efficacy or pharmacokinetic properties of Neurogen's drug candidates or other properties of drug candidates which could make them unattractive for commercialization, advancement of competitive products, dependence on corporate partners, Neurogen's ability to retain key employees, sufficiency of cash to fund Neurogen's planned operations and patent, product liability and third party reimbursement risks associated with the pharmaceutical industry. Although Neurogen believes that its expectations are based on reasonable assumptions, it can give no assurance that the anticipated results will occur. 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. Forward-looking statements represent the judgment of Neurogen's management as of the date of this release and Neurogen disclaims any intent and does not assume any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, unless required under applicable law.
Elaine Grimsell Dodge, 203-315-4615
Posted: November 2007
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