BRANFORD, Conn., May 11 /PRNewswire-FirstCall/ -- Neurogen Corporation today announced top-line results of Phase II human testing in transient insomnia for the Company's internally discovered drug candidate for insomnia, 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 this multi-center, 369 subject study, NG2-73 was shown to significantly reduce time to onset of persistent sleep versus placebo at all doses tested.
Study Results
In top-line results, NG2-73 demonstrated statistically significant improvement over placebo (overall p<0.0001) for reducing Latency to Persistent Sleep (LPS) at all doses tested.
The following table shows mean LPS in minutes: placebo 1mg 3mg 10mg 20mg (n=74) (n=73) (n=69) (n=72) (n=71) -- LPS 30.8 17.8 10.6 7.8 6.6 -- p value <0.01 <0.001 <0.001 <0.001 -- percent improvement 42% 65% 75% 79% relative to placebo
In this study NG2-73 was well-tolerated at all doses, with no drug-related serious adverse events or drug-related premature subject withdrawals.
Commenting on the study results, principal investigator Gary Zammit, Ph.D., President & CEO of CliniLabs, Inc. and Clinical Associate Professor of Psychology (in Psychiatry), Columbia University College of Physicians and Surgeons, said, "In studies to date, NG2-73 has been shown to be a safe and potent sleep agent that reduces sleep latency and increases total sleep time and sleep efficiency. The fast onset of action of this compound may serve to differentiate it from other sleep agents, providing an important treatment option for patients suffering from insomnia."
William H. Koster, President and CEO, said, "We are excited to have met our primary endpoint in this Phase II study in such a conclusive manner. We have confirmation of the efficacy of NG2-73 and have narrowed our focus on the therapeutic dose range which we'll be taking into subsequent studies. As in our previous Phase I studies, NG2-73 was well-tolerated, an essential characteristic for therapeutic agents for the treatment of patients with insomnia.
"Over 20 million people in the United States are estimated to suffer from some form of insomnia and the market is expected to grow dramatically over the next several years. The needs of insomnia patients vary greatly and the emerging treatments, such as NG2-73, should help to much better serve this patient population."
Study Design
The Phase II clinical trial was a randomized, double-blind, placebo- controlled study, designed to determine the efficacy of four dose levels (1, 3, 10 and 20 mg) of NG2-73 compared to placebo in reducing the time it takes to fall asleep as defined by LPS. Dose selection was made on the basis of a prior Phase I pharmacokinetic/pharmacodynamic (PK/PD) trial which studied a range of doses of NG2-73 against placebo and an active comparator.
In this Phase II study, LPS was measured in a single-night, validated model of transient insomnia. The exposure response relationship for NG2-73 is being examined using PK/PD modeling. The study was conducted at 11 sites in the United States. Healthy adult subjects were enrolled in five treatment arms totaling 369 subjects.
NG2-73 is a partial agonist, preferential for the alpha-3 receptor subtype of the gamma-aminobutyric acid (GABAA) neurotransmitter system. NG2-73 and related compounds are a part of Neurogen's wholly-owned insomnia program. During 2005, Neurogen announced results from a first-in-human, single ascending dose study and a multiple ascending dose study for NG2-73. In both of these Phase I trials, the compound was safe and well-tolerated with no serious adverse events.
Webcast
Neurogen will host a conference call and webcast to discuss this announcement at 8:30 a.m. EDT today, May 11, 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 p.m. EDT today and accessible through the close of business May 25, 2006. To replay the conference call, dial 888-286-8010, or for international callers, 617-801-6888, and use the pass code: 27877246.
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 CorporationCONTACT: Elaine Grimsell Dodge of Neurogen Corp., +1-203-315-4615,edodge@nrgn.com
Web site: http://www.neurogen.com/
