Healthcare Industry News: restless legs syndrome
News Release - May 2, 2007
Neurogen Announces Results of First-in-Human Trial for New Approach to Treating ObesityBRANFORD, Conn.--(HSMN NewsFeed)--Neurogen Corporation (Nasdaq: NRGN ) today announced that it has completed a single ascending dose, first-in-human study with NGD-4715, the Company's leading drug candidate for the treatment of obesity. NGD-4715 works as a small molecule antagonist at the melanin concentrating hormone receptor-1 (MCHR1). The compound was safe and well tolerated at all doses studied in this clinical trial.
MCHR1 represents a new biological target for treating obesity and is the subject of research programs at many major pharmaceutical companies. Neurogen believes its MCHR1 program may be the most advanced in the industry. NGD-4715 and other compounds in the Company's MCHR1 obesity program are wholly-owned by Neurogen.
The recently completed Phase I clinical trial was a randomized, double-blind, placebo-controlled evaluation in healthy overweight and obese subjects of the safety, tolerability and pharmacokinetics of single rising oral doses of NGD-4715. The study enrolled 71 male and female subjects. NGD-4715 was studied across a broad range of doses in this trial and was safe and well tolerated at all doses. During the trial, blood levels of the compound exhibited a consistent dose dependent increase.
William H. Koster, President and CEO, said, "We are exploring an entirely new target for therapeutics to treat obesity and are extremely pleased that NGD-4715 is advancing in human clinical studies. Next, we will conduct a multiple ascending dose study in healthy volunteers and then plan to proceed into a Phase 2 proof-of-concept study in obese patients.
"While the MCHR1 mechanism has been an area 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 with this promising new target 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."
Neurogen's obesity program is focused on blocking the melanin concentrating hormone receptor-1 (MCHR1). 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 MCHR1 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 MCHR1 antagonist in a non-rodent species that, like humans, expresses both a MCH type 1 and MCH type 2 receptor. The Company's studies indicated that selectively blocking MCHR1 was sufficient to achieve a significant reduction in food intake in a higher animal species.
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, restless legs syndrome (RLS), Parkinson's disease, pain, obesity, and depression. 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.
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