Neurogen Announces Progress in Its Drug Development Programs to Treat Anxiety and Alzheimer's Disease
BRANFORD, Conn., Feb. 17 /PRNewswire/ -- Neurogen Corporation (Nasdaq: NRGN - news), a leading drug discovery and development company, today announced progress in its clinical development drug programs to treat anxiety and Alzheimer's disease. In these discovery programs, Neurogen's goal is to discover multiple chemical series from which to select multiple drug candidates for advancement through clinical development. Both the anxiety and Alzheimer's disease drug programs are partnered with Pfizer Inc, in an arrangement where Neurogen discovers new drug candidates, and Pfizer conducts all clinical trials.
Alzheimer's Disease Program - GABA
Neurogen and Pfizer are collaborating to develop drugs to treat Alzheimer's disease, for which there is a growing market opportunity, and few effective prescription drug treatments are available. The Neurogen /Pfizer collaboration has yielded drug candidates designed to enhance cognition by acting in the brain's memory centers as highly selective inverse agonists of specific GABA receptor subtypes. Drug candidates from the collaboration improve memory in a variety of laboratory animal models.
In preparation for Phase II studies in the US, an Investigational New Drug Application (IND) was filed by Pfizer with the FDA and has recently become effective. Multiple dosing Phase I studies examining the safety and pharmacokinetics of the collaboration's most advanced drug candidate in healthy young and elderly human volunteers are nearing completion in Europe. Results of Phase I clinical trials conducted to date indicate that this compound is well-tolerated.
Anxiety/Depression Program -- GABA
Neurogen and Pfizer are also developing fast-acting drugs to treat anxiety without the side effects, such as sedation and memory impairment, of currently marketed drugs like Valium© and Xanax©. Neurogen believes that safer, fast-acting drugs to treat anxiety would greatly expand the market, just as safer anti-depressants such as Prozac© have expanded the market for anti-depressants. Candidates from the anxiety/depression program act as selective partial agonists of the GABA receptor, and have demonstrated robust anti-anxiety activity in pre-clinical animal models without producing the side effects of the benzodiazepine anxiolytics.
One of the most advanced drug candidates has recently completed single-dose Phase I human clinical studies examining the safety and pharmacokinetics across several dosing levels. Results of Phase I clinical trials conducted to date indicate that the candidate is well-tolerated.
Neurogen is a leader in both the discovery and development of new drug candidates and in the development and integration of new drug discovery technologies, most notably its AIDD (Accelerated Intelligent Drug Discovery) system. Neurogen has generated a growing portfolio of compelling new drug programs that promise improved efficacy and reduced side effects in the treatment of large market psychiatric, metabolic and inflammatory disorders. Through strategic collaborations with world-class pharmaceutical companies, Neurogen couples its ability to generate multiple drug candidates with the proven drug development and marketing expertise of its partners. These collaborations help to finance the company's operations and hold the promise of valuable royalties and profit sharing upon the commercialization of Neurogen's products. Neurogen also finances its activities via licenses of its AIDD system to other companies.
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 Company research, 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. |
