BRANFORD, Conn., Nov. 13 /PRNewswire-FirstCall/ -- Neurogen Corporation today announced that it has commenced Phase I human testing of the Company's leading drug candidate for treatment of obesity. The compound, NGD-4715, works as an antagonist at the melanin concentrating hormone receptor-1 (MCH1). NGD-4715 and other compounds in the Company's obesity program are wholly-owned by Neurogen.
William H. Koster, President and CEO, said, "We are extremely pleased to be entering human testing exploring this promising new target. While the MCH1 mechanism has been a target of high interest in the pharmaceutical community, we believe most in the industry have encountered significant obstacles to advancing drug candidates into human studies. Neurogen has established a leading position in this promising new arena and we hope to provide an effective therapeutic for the growing number of patients affected by obesity and its many co-morbidities, including diabetes and hypertension."
The ongoing Phase I clinical trial is a randomized, double-blind, placebo-controlled evaluation in healthy overweight and obese subjects of the safety, pharmacokinetics, and pharmacodynamics of single rising oral doses of NGD-4715. The study has a planned total enrollment of up to 84 male and female subjects. This single center study will be conducted in the U.S. and standard safety assessments will be made.
Neurogen's obesity program is focused on blocking the melanin concentrating hormone receptor-1 (MCH1). When the neuropeptide MCH binds to the receptor it stimulates food intake. Reported studies in rodents support MCH being an important mediator of caloric intake. Deletion of MCH or the MCH1 receptor gene resulted in lean animals, while over-production of MCH caused increased weight gain. Neurogen scientists presented data at the North American Association for the Study of Obesity (NAASO) in November 2004, which the Company believes was the first reported finding of the utility of an MCH1 antagonist in a non-rodent species. The Company's studies indicated that selectively blocking MCH1 was sufficient to achieve a significant reduction in food intake in a higher animal species.
Webcast
Neurogen will host a conference call and webcast to discuss this announcement at 8:30 a.m. ET today, November 13, 2006. 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 p.m. ET today and accessible through the close of business November 27, 2006. To replay the conference call, dial 888-286-8010, or for international callers, 617-801-6888, and use the pass code: 47103054.
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 CorporationCONTACT: Elaine Grimsell Dodge of Neurogen Corp., +1-203-315-4615, oredodge@nrgn.com
Web site: http://www.neurogen.com/
