Neurocrine Announces Phase I Clinical Trial Results with Its Proprietary CRF1 Receptor Antagonist Compound for Depression and Anxiety
SAN DIEGO, March 8 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today the completion of a Phase I clinical trial with its proprietary Corticotropin Releasing Factor (CRF) receptor antagonist compound for the treatment of depression and anxiety. This Phase I, randomized, double-blind, placebo-controlled, single-dose trial was conducted in 48 normal healthy volunteers and was designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics, including endocrine profiles, over a range of six escalating doses. Initial pharmacokinetic evaluation indicates rapid absorption and good dose-proportionality and plasma half lives supportive of a once-a-day dosing schedule. No safety issues were noted which would preclude advancement into the next phase of clinical evaluation. A two week multiple dose, dose-escalating Phase I placebo controlled clinical trial will be initiated to further evaluate the safety and endocrine profiles of this compound to prepare for Phase II efficacy evaluation.
"We are encouraged by this Phase I data and look forward to moving to the next phase of clinical development with this compound," said Gary Lyons, President and CEO. "The rapid completion of this clinical trial reinforces our goal to remain the world leader in the CRF field."
Dr. Wylie Vale, Neurocrine co-founder, first identified and cloned the CRF receptor along with his colleagues at the Salk Institute. CRF functions as a neurotransmitter in the brain and plays a critical role in coordinating the body's response to stress. The CRF1 receptor subtype largely mediates these effects. In preclinical models, selective CRF1 receptor antagonists block stress-related responses providing further evidence that this novel mechanism may result in improved anti-anxiety and anti-depressant properties. In addition, some data suggests that CRF1 antagonists may have a more rapid onset of action and a reduced side effect profile compared to currently marketed anti-depressants. According to Mental Health: A Report of the Surgeon General, 16.4% of the U.S. population suffers from anxiety, and over 6% suffer from depression.
Neurocrine Biosciences is a leading neuroscience company focused on the discovery and development of novel therapeutics for neuropsychiatric, neuroinflammatory and neurodegenerative diseases and disorders. The Company's neuroscience, endocrine and immunology disciplines provide a unique biological understanding of the molecular interaction between central nervous, immune and endocrine systems for the development of therapeutic interventions for anxiety, depression, insomnia, stroke, malignant brain tumors, multiple sclerosis, obesity and diabetes.
Neurocrine Biosciences, Inc. news releases are available through the Company's website via the Internet at http://www.neurocrine.com.
In addition to historical facts, this press release contains
forward-looking statements that involve a number of risks and uncertainties.
Among the factors that could cause actual results to differ materially from
those indicated in the forward looking statements are risks and uncertainties
associated with Neurocrine's proprietary CRF1 receptor antagonist program
including, but not limited to, risk that the program will not successfully
proceed to later stage clinical trials or that later stage clinical trials
will not show that it is effective in treating humans; determinations by
regulatory and governmental authorities; uncertainties relating to patent
protection and intellectual property rights of third parties; impact of
competitive products and technological changes; availability of capital and
cost of capital; and other material risks. A more complete description of
these risks can be found in the Company's Form 10K for the year ended
December 31, 1999 as amended, the current form 10Q and its most recent
registration statement, as filed with the Securities and Exchange Commission,
each of which should be read before making any investment in Neurocrine common
stock. Neurocrine undertakes no obligation to update the statements contained
in this press release after the date hereof.
SOURCE Neurocrine Biosciences, Inc.
Web site: http: //www.neurocrine.com
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CONTACT: Claudia Jones, or Paul Hawran, both of Neurocrine Biosciences, 858-658-7600