Thursday December 20, 9:16 am Eastern Time
Press Release
SOURCE: Neurogen Corporation
Neurogen Corporation Announces Results of Phase IIA Clinical Trial For Treatment of Generalized Anxiety Disorder
BRANFORD, Conn., Dec. 20 /PRNewswire/ -- Neurogen Corporation (Nasdaq: NRGN - news), a leading small molecule drug discovery and development company, today announced preliminary results from a Phase IIA clinical study of NGD 91-3, the Company's lead drug candidate for the treatment of anxiety disorders. NGD 91-3 is one of several drug candidates that work through selective modulation of the neurotransmitter system known as GABA (gamma aminobutyric acid), which are being developed for treatment of neuropsychiatric disorders in collaboration with Pfizer Inc (NYSE: PFE - news).
The Phase IIA clinical trial conducted by Pfizer was a randomized, double-blind, placebo-controlled evaluation of the safety, pharmacokinetics, and efficacy of NGD 91-3 in patients suffering from generalized anxiety disorder (GAD). Phase II clinical trials are designed to explore the potential efficacy and safety of the drug in a targeted patient population, and to determine drug doses most appropriate for future clinical trials.
The efficacy of NGD 91-3 was assessed in a six-week Phase IIA clinical trial using approximately 280 patients. Four groups of approximately 70 patients received either of two dosages of NGD 91-3, Xanax®, or placebo. The primary efficacy endpoint was improvement in the patient's condition as measured by the Hamilton Anxiety scale. In the study, subjects tested at the high dose of NGD 91-3 showed a trend toward efficacy that did not achieve statistical significance. This trend toward efficacy in subjects treated with the high dose was not associated with adverse events such as sleepiness, lack of coordination, and dizziness observed in subjects receiving Xanax. No effect was seen in subjects on the low dose of NGD 91-3.
William H. Koster, Ph.D, President and CEO of Neurogen, said, ``We are on the cutting edge of understanding how gabaergic systems work in the brain. Clinical studies with NGD 91-3 have been designed to explore a breakthrough concept for the treatment of anxiety. Analysis of exposure levels and potential therapeutic window will determine our next steps with our partner Pfizer.''
In collaboration with Pfizer, Neurogen is developing sub-type selective GABA -based drugs for the treatment of anxiety, Alzheimer's disease, and sleep disorders. Currently, Pfizer is conducting a Phase IIa study with Neurogen's lead drug candidate for the treatment of Alzheimer's disease, NGD 97-1. Pfizer is also conducting pre-clinical studies of collaboration candidates for the treatment of insomnia.
Dr. Koster will host a conference call to discuss the Phase IIA clinical trial results, as well the worldwide collaboration with Aventis Pharma to develop CRF1 drugs, also announced today. The call will take place at 10:30 a.m. EST on Thursday, December 20, 2001 and will be broadcast live via the internet at www.neurogen.com. An archive will be available on the website for at least one week following the call. A replay of the call will also be accessible by telephone after 1 p.m. EST, available through midnight, December 27, 2001. To replay the call, dial 800.945.0822 (direct dial is 402.220.0668).
About Neurogen Corp.
Neurogen Corp. is a leader in the discovery and development of new drug candidates targeted at improving the lives of patients suffering from psychiatric, metabolic and inflammatory disorders. The Company has generated a portfolio of compelling new drug programs, and through strategic collaborations with world-class pharmaceutical companies, accesses proven drug development and marketing expertise. Neurogen's Accelerated Intelligent Drug Discovery (AIDD) system is a key discriminator in the Company's ability to rapidly and cost effectively screen for active compounds during the drug discovery process.
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 of the Company's drug candidates, advancement of competitive products, dependence on corporate partners, difficulties or delays in development, delivery or performance of the Company's AIDD-related systems and business, sufficiency of cash to fund the Company's planned operations and patent, product liability and third party reimbursement risks associated with the pharmaceutical industry.
SOURCE: Neurogen Corporation |
