Nice results - they even snuck in some good CRF news at the end.
My particular thanks to Rick, Miljenko and others for this one - I've just been blindly and happily tagging along here.
Headline: Neurocrine Biosciences, Inc. Reports Positive Phase II Results With
New Insomnia Drug
======================================================================
SAN DIEGO, Nov. 29 /PRNewswire/ -- Neurocrine Biosciences, Inc.
(NASDAQ:NBIX) today announced results from a Phase II clinical trial
demonstrating that NBI-34060 is a robust sedative hypnotic as demonstrated by
a highly statistically significant and clinically relevant effect in inducing
sleep when compared to placebo. These data confirm that NBI-34060 is safe and
effective in helping subjects with transient insomnia achieve rapid sleep
induction without next day residual effects associated with most currently
marketed sleep hypnotics.
The results indicate statistical significance was reached for the primary
clinical endpoint (Latency to Persistent Sleep-LPS), the required regulatory
endpoint for approval. In this study, which enrolled 228 transient insomnia
subjects, those subjects receiving NBI-34060 the mean time to LPS was 16
minutes compared to 34 minutes in the placebo group (p less than .001). In
addition, the data indicated that a majority of subjects in the treated group
fell asleep within 9 minutes as indicated by the median time to LPS as
compared to 23 minutes in the placebo group.
"An ideal sedative does not exist in the market today," said Dr. Thomas
Roth, Chief, Division Head, Sleep Disorders and Research Center, Henry Ford
Hospital. "By successfully combining efficacy (on multiple measures) with
safety (low side effects, hangover, abuse liability), NBI-34060 will address
the market need expressed by both physicians and consumers for an ideal
sedative."
The Phase II clinical trial was a randomized-double blinded placebo
controlled, multi-center Phase II clinical trial of NBI-34060 in 228 subjects
with transient insomnia. The study was conducted in a sleep laboratory
setting employing objective polysomnographic assessments. The safety findings
indicate that NBI-34060 was safe and well tolerated at doses up to 30 mg.
There were no serious adverse events reported in this clinical trial. Overall
there was a low incidence of adverse effects which was comparable to that
observed in the placebo group with no residual next day hangover effects.
"We are pleased with these robust efficacy findings. By successfully
combining better efficacy and safety, we believe NBI-34060 will become the
first choice for treating insomnia by prescribing physicians and those who
suffer from insomnia," said Gary A. Lyons, President and Chief Executive
Officer of Neurocrine Biosciences. "These results confirm that NBI-34060 has
the potential to compete effectively in the $1 billion sleep hypnotic market."
Lyons added that "Neurocrine is moving rapidly to expand clinical
development of NBI-34060 and plans to initiate a dose-response,
randomized-placebo controlled, multi-center Phase II study in over 550
subjects in the 2nd Quarter 2000. These studies will be conducted in subjects
with chronic insomnia and will include other subject sub-groups. Neurocrine
is also designing a large scale pivotal Phase III program in more than 1500
subjects scheduled to begin in late 2000."
In addition at an investor conference this week, Florian Holsboer, M.D.,
PhD of the Max Planck Institute for Psychiatry in Germany presented
preliminary safety and efficacy results on 20 subjects in an open-label Phase
II study with a CRF receptor antagonist (R121919/NBI-30775). This compound is
being developed by Neurocrine and Janssen Pharmaceutica for
anxiety/depression. Results indicated a statistically significant improvement
in widely accepted measures of anxiety and depression. Comprehensive findings
from this trial will be finalized and Dr. Holsboer will present a full
analysis in early 2000.
<snip>
SOURCE Neurocrine Biosciences, Inc.
-0- 11/29/1999
/CONTACT: Elizabeth Foster or Paul Hawran, both of Neurocrine
Biosciences, 619-658-7600/
/Web site: neurocrine.com
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