BRANFORD, Conn., Nov. 1 /PRNewswire-FirstCall/ -- Neurogen Corporation today announced that Merck & Co. Inc., through an affiliate, has begun a Phase II proof-of-concept clinical trial to study MK-2295 (NGD-8243) for the treatment of post-operative dental pain. MK-2295 is one of several drug candidates Merck is developing as part of its exclusive worldwide alliance with Neurogen to develop oral medicines targeting the VR1 receptor.
The initiation of the Phase II study triggers a $3 million milestone payment from Merck to Neurogen. Through the alliance, Neurogen and Merck have generated a broad spectrum of chemical intellectual property and several leading drug candidates, including MK-2295. The companies will select the most promising of the lead candidates for further development once proof-of-concept has been established.
The Phase II proof-of-concept trial is a randomized, double-blind, placebo controlled study, designed to determine the efficacy of MK-2295 in the treatment of post-operative dental pain. In single ascending dose Phase I trials conducted to date, MK-2295 was potent and active at the VR1 target and generally well tolerated with no serious adverse events. Multiple ascending dose studies are ongoing.
“VR1 receptor antagonists have the potential to alleviate pain, including pain from inflammatory states,” said William H. Koster, PhD, President and CEO of Neurogen. “We look forward to learning more about this promising new mechanism as clinical development continues.”
About the VR1 Program
Neurogen’s exclusive worldwide alliance with Merck to research, develop and commercialize next-generation drugs for the treatment of pain and other disorders began in January 2004. The partnership enabled Merck and Neurogen to pool drug candidates targeting the type 1 vanilloid receptor (VR1), a key integrator of pain signals in the nervous system, and combine their ongoing VR1 programs to form a global research and development collaboration.
About Neurogen
Neurogen Corporation targets new 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 to obtain additional resources and to access complementary 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.
Neurogen Corporation
CONTACT: Elaine Grimsell Dodge of Neurogen Corp., +1-203-315-4615,edodge@nrgn.com
Web site: http://www.neurogen.com/
