December 27, 2000
Sanjib Dutta, BridgeNews
New York--Dec. 22--Neurocrine Biosciences Inc. started the Phase I clinical trials of Corticotropin Releasing Factor1, a receptor antagonist compound, in 48 volunteers. Corticotropin is for the treatment of anxiety and depression.
The following is the text of today's announcement with emphasis added by BridgeNews. BridgeStation links to company data have been inserted at the end:
Neurocrine Biosciences Announces
Initiation of Phase I Clinical Trial in Anxiety and Depression With Proprietary
CRF1 Receptor Antagonist
SAN DIEGO--(BW Healthwire)--Dec.
22, 2000--
Janssen Collaboration
Also Moves Forward With CRF1 Development
Compound
NEUROCRINE BIOSCIENCES
INC. (NASDAQ:NBIX) TODAY ANNOUNCED THE INITIATION OF A PHASE I CLINICAL
TRIAL WITH ITS PROPRIETARY CORTICOTROPIN RELEASING FACTOR1 (CRF1) RECEPTOR
ANTAGONIST COMPOUND FOR THE TREATMENT OF ANXIETY AND DEPRESSION.
THIS TRIAL IS BEING
CONDUCTED IN 48 NORMAL, HEALTHY VOLUNTEERS AND IS DESIGNED TO EVALUATE
THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS INCLUDING
ENDOCRINE PROFILES OVER A RANGE OF ESCALATING DOSES. TO DATE, THE TWO DOSING
GROUPS INVOLVING 16 SUBJECTS HAVE COMPLETED TREATMENT AND INITIAL KINETIC
EVALUATION INDICATE GOOD AND RAPID ABSORPTION WITH NO OBSERVABLE SIDE EFFECTS
OR SAFETY CONCERNS. AFTER SUCCESSFUL COMPLETION OF THIS STUDY IN FEBRUARY,
A MULTIPLE DOSE ESCALATING TRIAL WILL BE INITIATED TO FURTHER EVALUATE
THE SAFETY AND ENDOCRINE PROFILES OF THIS COMPOUND FOLLOWED BY PHASE II
STUDIES IN ANXIETY AND DEPRESSION. WITH THE INITIATION OF THIS TRIAL, NEUROCRINE
NOW HAS FIVE CLINICAL DEVELOPMENT PROGRAMS INCLUDING INSOMNIA, MALIGNANT
GLIOMA, DIABETES AND MULTIPLE SCLEROSIS WITH TWO ADDITIONAL COMPOUNDS PLANNED
TO ENTER NEW PHASE I STUDIES IN 2001.
"Enthusiasm for the
utility of CRF receptor antagonist for anxiety and depression has gained
significant momentum in the past few years. Early preliminary success with
the first generation CRF antagonist has intensified the excitement around
this novel mechanism in psychiatry," said Dr. Stan Watson, co-director
and senior research scientist at the Mental Health Research Institute at
the University of Michigan and member of the Scientific Advisory Board
of Neurocrine Biosciences.
IN ADDITION, NEUROCRINE'S
PARTNERED CRF RECEPTOR ANTAGONIST COMPOUND (NBI 37582) HAS ACHIEVED AN
IMPORTANT MILESTONE AND HAS BEEN NOMINATED FOR FULL SCALE DEVELOPMENT BY
PARTNER JANSSEN PHARMACEUTICA (A SUBSIDIARY OF JOHNSON & JOHNSON).
NBI 37582 has been advanced to development status and is expected to move
into Phase I clinical trials by 3rd Quarter 2001 following completion of
GLP (Good Laboratory Practices) and GMP (Good Manufacturing Practices)
studies. This will complete the research phase of Neurocrine's collaboration
with Janssen Pharmaceutica.
"It is our goal to
remain the world leader in the CRF field. We are pleased with the progress
we have made with our new second generation CRF receptor antagonist programs
this year," said Gary Lyons, president & CEO of Neurocrine. "The Janssen
program and our internal proprietary programs represent two independent
programs for the discovery and development of novel therapeutics for the
treatment of anxiety and depression and demonstrates our commitment to
this field. It remains our strategy to advance several proprietary CRF
compounds into clinical development so as to select the compound with the
best safety and efficacy profile for definitive Phase II trials. Our research
in this area has also expanded this year and has demonstrated utility of
CRF antagonists in Irritable Bowel Syndrome, pain and neuro-protection."
CRF was first identified
and cloned by Neurocrine co-founder, Dr. Wylie Vale, and 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.
Neurocrine Biosciences
is a neuroscience based research and development biopharmaceutical company
focused on the development of therapeutic products in the areas of anxiety,
depression, insomnia, malignant brain tumors, diabetes and multiple sclerosis.
Neurocrine Biosciences
Inc. news releases are available through the company's Web site 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
research and development programs and business and finances including,
but not limited to, risks and uncertainties associated with, or arising
out of, drug discovery, pre-clinical and clinical development of products
including risk that research may not generate development candidates, development
candidates will not successfully proceed through early clinical trials
or that in later stage clinical trials will not show that they are effective
in treating humans; determinations by regulatory and governmental authorities;
changes in relationships with strategic partners and dependence upon strategic
partners for performance of clinical and commercialization activities under
collaborative agreements including potential for any collaboration agreement
to be terminated without any product success; 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
Dec. 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.
CONTACT: Neurocrine
Biosciences
End Copyright 2000
Bridge Information Systems Inc. All rights reserved.
Claudia Jones or
Paul Hawran, 858/658-7600