LA JOLLA, Calif., July 21 /PRNewswire/ -- SIBIA Neurosciences, Inc.
(Nasdaq: SIBI) today announced results from two initial Phase 2 clinical
trials of SIB-1508Y (altinicline) in Parkinson's disease (PD) patients.
The first study, 201, was a parallel group, placebo controlled, multiple
dose study over four weeks of oral dosing primarily to assess the safety and
tolerability and secondarily the efficacy of altinicline against both motor
and cognitive symptoms in early stage PD patients who were not currently
receiving dopaminergic therapy. In this study, a range of well tolerated
doses was established with the dosing regimen used. Altinicline did not
demonstrate statistically significant improvement relative to placebo in the
global analysis; however, an unusually high placebo response rate was observed
in this trial. Despite this, altinicline, at a well-tolerated dose, showed
improvement relative to baseline status, and in some cases to placebo, in
certain motor and cognitive measures.
The second study, 202, was a crossover design examining acute motor and
cognitive performance over an eight hour period in which later stage patients
received either placebo or one of three doses of altinicline in random order
along with half of their normally effective dose of L-DOPA on each of four
treatment days. In this acute study, altinicline was not statistically
significantly different from placebo in the global analysis. However, a trend
to significance was noted and significant differences between doses of
altinicline were observed, suggesting a dose-response effect. The study also
demonstrated that later stage patients tolerated altinicline in the presence
of L-DOPA.
Jeffrey McKelvy, Ph.D., SIBIA's Chief Scientific Officer, reported, "In
these studies we found altinicline to be safe in the regimen used, and we
defined tolerability over a broad dose range. Whereas statistical
significance was not observed, we believe that future studies are warranted
based on the observed tolerability and the efficacy trends noted. These data
will be valuable for the design of longer term studies of altinicline. At
present, SIBIA intends that any future studies would be carried out by
corporate partners."
SIBIA Neurosciences, Inc. is engaged in the discovery and development of
novel small molecule therapeutics for the treatment of neurodegenerative,
neuropsychiatric and neurological disorders, many of which have large patient
populations and represent critical unmet medical needs. SIBIA is a leader in
the development of proprietary drug discovery platforms that combine key tools
necessary for modern drug discovery, including genomics, high throughput
screening, advanced combinatorial chemistry techniques and pharmacology. The
Company's proprietary molecular targets and drug candidates, together with its
drug discovery technologies and research expertise, have enabled the Company
to establish several corporate collaborations, which currently include Eli
Lilly and Company, Bristol-Myers Squibb Company and Meiji Seika Kaisha, Ltd.,
and multiple technology licensing arrangements.
This press release contains forward-looking statements that involve risks
and uncertainties. Actual results could differ materially from those
discussed herein. These risks and uncertainties include whether SIBIA or its
partners will pursue future clinical studies of altinicline, whether SIBIA
will be able to meet its development goals with respect to its drug
candidates, whether SIBIA's clinical trials will yield favorable results with
respect to the efficacy of altinicline, or more generally the new and
uncertain state of SIBIA's technologies, SIBIA's future capital needs and the
uncertainty of receiving additional funding, uncertainties regarding patents
and proprietary rights, and other research, development and market risks.
These and other risks and uncertainties are more fully set forth in SIBIA's
most recently filed Forms 10-Q and 10-K.
SOURCE SIBIA Neurosciences, Inc.
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CONTACT: Jeffrey F. McKelvy, Ph.D., Executive Vice President and CSO of SIBIA Neurosciences, Inc., 619-452-5892 ext. 229, jmckelvy@sibia.com
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